The Effects of Valerian on Sleep Quality, Depression, and State Anxiety in Hemodialysis Patients: A Randomized, Double-blind, Crossover Clinical Trial

Objectives: Our study sought to determine the effects of valerian on sleep quality, depression, and state anxiety in hemodialysis (HD) patients. Methods: This randomized, double-blind, placebo-controlled, crossover clinical trial was conducted on 39 patients undergoing HD allocated into a valerian and placebo group. In the first phase of the study, group A (n = 19) received valerian and group B (n = 20) received a placebo one hour before sleep every night for a total of one month. Sleep quality, state anxiety, and depression were assessed in the patients at the beginning and end of the intervention using the Pittsburgh Sleep Quality Index, the Spielberger State-Trait Anxiety Inventory, and Beck Depression Inventory. In the second phase, the two groups’ treatment regimen was swapped. After a one-month washout period, the same process was repeated on the crossover groups (i.e., group A received placebo and group B received valerian). Results: In the first phase, the mean sleep quality, depression, and state anxiety scores showed significant reductions in both groups, but the reduction was significantly higher in group A compared to group B (7.6 vs. 3.2, p < 0.001; 6.5 vs. 2.3, p = 0.013; 14.6 vs. 7.3, p = 0.003, respectively). In the second phase, the mean sleep disorder, depression, and state anxiety scores showed significant reductions in both groups, but the reduction was significantly lower in group A compared to group B (1.4 vs. 4.6, p < 0.001; 1.2 vs. 3.8, p = 0.002; 1.5 vs. 6.2, p < 0.001, respectively). Conclusions: Valerian significantly improved sleep quality, the symptoms of state anxiety, and depression in HD patients.

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The role of tolvaptan in prevention of hyponatremia in patients undergoing transurethral resection of prostate surgery- A randomized double blind study

Indian Journal of Clinical Anaesthesia ◽

10.18231/j.ijca.2021.059 ◽

2021 ◽

Vol 8 (2) ◽

pp. 321-325

Author(s):

Dinesh Kumar Singh ◽

B B Baj ◽

Vipin Goyal

Keyword(s):

Transurethral Resection ◽

Blind Study ◽

Transurethral Resection Of Prostate ◽

Double Blind Study ◽

Double Blind ◽

Significant Difference ◽

Group A ◽

The Mean ◽

Group B

The aim of our study to determine the role of tolvaptan in prevention of hyponatremia in transurethral resection of prostate surgery. This is randomized double-blind study conducted in 60 ASA grade status 1 and 2 patients age group between 45-80 yrs undergoing TURP under spinal anaesthesia in urology operation theatre in Mahatma Gandhi hospital Jaipur after receiving permission from hospital ethical committee. A detailed history, complete physical examination and routine investigation were done for all patients followed by informed written consent was obtained. Patients are randomly divided into 2 groups. In group A -30 patients who received orally tab tolvaptan 15 mg and group B-30 patients who received orally tab multivitamin 2 hrs before surgery after doing electrolytes of the patients in the morning. In both groups age (in yrs), wt (in kg), ASA grade, volume of irrigating fluid (in litres), volume of prostate resected (in gm) and duration of surgery (in minutes) all demographic and surgical details data were compared. Electrolytes were compared in both groups pre and post-operatively and statistical analysis was done.There was significant difference in post-operative sodium level between the two groups (A and B). The mean level of sodium significantly reduced post-operatively in group –B (control grp). The mean level of sodium significantly increased post-operatively in group –A (tolvaptan grp). We conclude single dose of tolvaptan -15 mg found to effective in prevention of hyponatremia in patients undergoing TURP.

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A Double-Blind Randomized Prospective Study Comparing Ondansetron with Droperidol in the Prevention of Emesis following Strabismus Surgery

Anaesthesia and Intensive Care ◽

10.1177/0310057x9502300404 ◽

1995 ◽

Vol 23 (4) ◽

pp. 438-443 ◽

Cited By ~ 25

Author(s):

A. Davis ◽

S. Krige ◽

D. Moyes

Keyword(s):

Recovery Time ◽

Strabismus Surgery ◽

Double Blind Study ◽

Double Blind ◽

Oral Fluids ◽

Group A ◽

The Mean ◽

Group B ◽

To Receive ◽

Mean Time

A prospective double-blind study was conducted to compare the anti-emetic efficacy of ondansetron and droperidol in preventing postoperative emesis following strabismus surgery. A sample size of 213 patients was divided into three equal groups to receive ondansetron 150 μg/kg (Group A), ondansetron 75 μg/kg (Group B), or droperidol 75 fig/kg (Group C). All patients received a standardized anaesthetic technique. All episodes of emesis, recovery time, and time to tolerating oral fluids were recorded. The incidence of emesis during 24 hours was Groups A and B 19.7%, and Group C 28.2%. The lower incidence of emesis recorded by the ondansetron groups compared with the droperidol group was not statistically significant. Ondansetron at 75 μg/kg was as effective as 150 μg/kg in reducing emesis when compared with droperidol. Mean time to discharge from the recovery room was 75.3 minutes (Group A), 44.4 minutes (Group B), and 41.0 minutes (Group C). The mean time to tolerating oral fluids was 356.5 minutes (Group A), 402.8 minutes (Group B), and 378.1 minutes (Group C). There was no statistical difference in discharge times from recovery or time to tolerating oral fluids in any of the three groups.

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Impact of vitamin A supplementation in anaemia during pregnancy: a randomized double blind controlled clinical trial

International Journal of Reproduction Contraception Obstetrics and Gynecology ◽

10.18203/2320-1770.ijrcog20182332 ◽

2018 ◽

Vol 7 (6) ◽

pp. 2262

Author(s):

Shakun Singh ◽

Rachna Chaudhary ◽

Vandana Dhama ◽

Anu Singh ◽

Urmila Karya

Keyword(s):

Clinical Trial ◽

Vitamin A ◽

Pregnant Women ◽

Controlled Clinical Trial ◽

Double Blind ◽

Vitamin A Supplementation ◽

Elemental Iron ◽

Group A ◽

Group B ◽

The Impact

Background: To study the impact of Vitamin A supplementation in anaemia during Pregnancy and thus improving maternal and fetal outcome a Randomized double blind controlled clinical trial was conducted in Department of Obstetrics and Gynaecology, L.L.R.M. Medical college Meerut involving 250 pregnant women in late pregnancy 18-28 weeks with haemoglobin levels <11 g% (7-11 g%)..Methods: The study subjects were divided into two groups: Group A (n=125): Received daily supplement containing Iron (60 mg elemental iron) + Folate (500 mcg) + Vitamin A 20,000 IU weekly for a minimum of 12 weeks. Group B (n=125): Received daily supplement containing iron (60 mg elemental iron) + Folate (500 mcg) for a minimum of 12 weeks.Results: Maximum patients were uneducated belonging to low socioeconomic status. The mean haemoglobin values in Group A and Group B increased from 9.674±1.05 and 9.53±1.04 to 12.2±0.89 and 10.82±1.06 respectively after supplementation. Similarily Serum Ferritin levels increased from 15.96±2.94 and 15.70±2.83 to 78.40±17.82 and 58.64±11.93. Mean corpuscular volume, packed cell volume and red blood cell counts also increased significantly. Maximum haemoglobin levels were achieved with both vitamin A and iron supplementation. The proportion of women who became non anaemic was 97.17% in Group A vs 68.69% in Group B.Conclusions: Vitamin A supplementation improves anaemia and also dramatically improves iron stores in anaemic pregnant women.

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Comparison of Preemptive Analgesic Effects of Intravenous Ketorolac and Oral Pregabalin in Patients Undergoing Mandibular Fracture Surgery: A Randomized Clinical Trial

Avicenna Journal of Dental Research ◽

10.34172/ajdr.2020.11 ◽

2020 ◽

Vol 12 (2) ◽

pp. 51-57

Author(s):

Javad Yazdani ◽

Saeed Nezafati ◽

Ali Mortazavi ◽

Farrokh Farhadi ◽

Milad Ghanizadeh

Keyword(s):

Clinical Trial ◽

Postoperative Pain ◽

Postoperative Period ◽

Opioid Analgesic ◽

Mandibular Fractures ◽

Analgesic Effects ◽

Group A ◽

The Mean ◽

Group B ◽

Intravenous Ketorolac

Background: Preemptive analgesia is one of the techniques to manage postoperative pain, which increases patient satisfaction and decreases the duration of hospitalization. The present study aimed to evaluate and compare the pain relief achieved by preoperative intravenous ketorolac and oral pregabalin in patients undergoing surgery for mandibular fractures. Methods: In the present clinical trial, 60 patients with unilateral fractures of the mandible were randomly assigned to two groups. In group A, intravenous injections of ketorolac 30 mg and in group B, pregabalin 150 mg capsules were administrated one hour preoperatively. The severity of pain was determined using a visual analog scale (VAS) up to 24 hours postoperatively. Finally, the total doses of an opioid analgesic (pethidine) prescribed for each patient in mg during the first 24 hours and the time for the request of the first analgesic dose in minutes were recorded for each patient. Then, their means were compared between the two groups. Results: Maximum pain severity was experienced immediately after surgery, which decreased gradually during the 24-hour postoperative period (P < 0.0001). The mean severity of pain immediately after regaining consciousness and the mean pain score during the 24-hour postoperative period were lower in the pregabalin group than in the ketorolac group (P < 0.0001). In the ketorolac group, a slightly higher dose of the opioid was administered; however, the difference was not significant (P > 0.05). Conclusions: The oral administration of pregabalin 150 mg one hour preoperatively was more effective than the intravenous administration of ketorolac 30 mg in relieving postoperative pain.

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Efektivitas terapi komplementer propolis telaah terhadap SGHT dan IL-33 sekret hidung penderita rinitis alergi

Oto Rhino Laryngologica Indonesiana ◽

10.32637/orli.v49i1.286 ◽

2019 ◽

Vol 49 (1) ◽

pp. 57

Author(s):

Yunis Sucipta Ibnu ◽

Dwi Reno Pawarti ◽

Mansyur Siddiq Wiyadi

Keyword(s):

Clinical Trial ◽

Allergic Rhinitis ◽

Randomized Clinical Trial ◽

Standard Therapy ◽

Nasal Secretion ◽

Tropical Disease ◽

Double Blind ◽

Interleukin 33 ◽

Group A ◽

Group B

Latar belakang: Rinitis alergi (RA) adalah inflamasi mukosa hidung yang diperantarai oleh IgE. Gejala dapat dinilai dengan Skor Gejala Hidung Total (SGHT). Patofisiologi dan manifestasi klinis RA dipengaruhi oleh berbagai sitokin diantaranya interleukin 33 (IL-33). Efektivitas propolis maupun flavonoid dalam menurunkan SGHT dan kadar IL-33 sekret hidung masih kontroversi. Tujuan: Membuktikan bahwa penambahan propolis pada terapi komplementer RA lebih efektif menurunkan SGHT dan kadar IL-33 sekret hidung. Metode: Penelitian double blind randomized clinical trial (RCT), dilakukan di Unit Rawat Jalan (URJ) Divisi Alergi Imunologi, Departemen Telinga Hidung Tenggorok-Bedah Kepala Leher (THT-KL) RSUD Dr. Soetomo, dan Institute of Tropical Disease, Universitas Airlangga, Surabaya pada bulan September 2018-Januari 2019. Pasien RA yang memenuhi kriteria inklusi diperiksa SGHT dan kadar IL-33 sekret hidung. Terapi diberikan selama 14 hari, evaluasi SGHT dan kadar IL-33 dilakukan hari ke-15. Hasil: Sepuluh sampel mendapat propolis dan terapi standar (kelompok A), sepuluh sampel mendapat terapi standar (kelompok B). Perbandingan SGHT antar kelompok setelah terapi rerata kelompok A=1,6 (SD 1,7), kelompok B=5,2 (SD 1,6). Uji Mann-Whitney satu arah p=0,001 menunjukkan SGHT antar kelompok setelah terapi berbeda signifikan (p<0,005). Rerata kadar IL-33 setelah terapi kelompok A=0,051 (SD 0,005), kelompok B=0,051 (SD 0,013). Uji t nilai p=0,881 menunjukkan kadar IL-33 sekret hidung antar kelompok setelah terapi berbeda tidak signifikan (p>0,005). Kesimpulan: Penambahan propolis sebagai terapi komplementer lebih efektif dalam menurunkan SGHT dibandingkan dengan terapi standar saja, namun tidak efektif dalam menurunkan kadar IL-33 sekret hidung penderita RA. Background: Allergic rhinitis (AR) is a nasal mucosa inflammation mediated by IgE. The symptoms severity is determined by total nasal symptom score (TNSS). The pathophysiology and clinical manifestations of AR are affected by several cytokines, one of which is interleukin 33 (IL-33). Efficacy of propolis or flavonoid in reducing TNSS and IL-33 level in nasal secretion is still a controversy. Purpose: To find out whether propolis addition to standard therapy could be more effective in reducing TNSS and IL-33 level of nasal secretion. Method: Double blind randomized clinical trial (RCT). The study was conducted at Outpatient unit of Department of Allergic and Immunology, Dr. Soetomo General Hospital, Surabaya and Institute of Tropical Disease (ITD) Universitas Airlangga. Allergic rhinitis patients who met inclusion criteria were examined for TNSS and IL-33 nasal secretion level. Therapy was given for 14 days, after which TNSS and IL-33 levels were evaluated on day 15th. Ten samples received propolis and standard therapy (group A), ten samples received standard therapy only (group B). Result: The comparison of TNSS groups after treatment: mean group A=1.6 (SD 1.7), and mean group B=5.2 (SD 1.6). One way Mann-Whitney test showed p=0.001 indicating the TNSS after treatment was significantly different (p<0.005). The comparison of IL-33: mean group A=0.051(SD=0.005) and mean group B=0.051(SD=0.013), t-test p=0.0881 indicating the IL-33 level of nasal secretion after treatment was not significantly different (p>0.005). Conclusion: Propolis as a complementary therapy was more effective reducing TNSS compared to standard therapy only, but it was not effective in reducing IL-33 level of nasal secretion.

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Effect and mechanism of YH0618 granule on chemotherapy- induced hair loss in patients with breast cancer: study protocol for a randomized, double-blind, multi-center clinical trial

10.21203/rs.2.222/v3 ◽

2019 ◽

Author(s):

Jie-shu You ◽

Li Guo ◽

Mei Huang ◽

Xin-lei Shi ◽

Man-di Lin ◽

...

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Clinical Trial ◽

Chinese Medicine ◽

Hair Loss ◽

Double Blind ◽

Kidney Deficiency ◽

Group A ◽

Group B

Abstract Background: Hair loss is one of the most common side effects of chemotherapy, which can cause persistent negative emotions, further affecting therapeutic effects and reducing the quality of life. However, there is no clinically safe and effective methods to solve the problem at present. Our previous clinical and animal studies showed that a medicinal and edible decoction YH0618 could significantly promote hair growth in cancer patients after chemotherapy, without interfering with the anti-tumor effect of chemotherapy. Besides, the theory of Chinese Medicine believes “Essence of the kidney is reflected on the hair”. Therefore, this study will further explore the efficacy of YH0618 granule on chemotherapy-induced hair loss in patients with breast cancer by a randomized, double-blind, multi-center clinical trial and elucidate the potential mechanism from the aspect of kidney deficiency or renal dysfunction. Methods/Design: Eligible breast cancer patients who will start chemotherapy will be randomly divided into group A (YH0618 granule) and group B (placebo). The chemotherapeutic agents contains Taxanes or/and Anthracyclines, and chemotherapy regimen will last at least 6 cycles with every three weeks a cycle. Subjects assigned to group A will receive YH0618 granules two times a day (6 g each time), 6 days a week, mixing with 300 ml warm water from the first to the fourth chemotherapy cycle. Subjects in group B will receive the placebo granule in the same manner. The primary outcome is the time point of occurrence of hair loss reaching grade II assessed by WHO Toxicity Grading Scale, and objective indexes of hair quality and hair follicle recorded by a hair and scalp detector before the fifth chemotherapy. Secondary outcomes include changes of facial color and thumbnails color, grading of thumbnails ridging, assessment of quality life, fatigue, routine blood test, hepatic and renal function, and some medical indicators which can reflect kidney deficiency in Chinese Medicine. Discussion: This research is of great significance for the treatment of cancer and improving the quality of life of patients. The study may provide the most direct evidence for meeting clinical needs and lay a solid scientific foundation for later product development. Trial registration: The trial was registered on 14 December 2018 at Chinese Clinical Trial Registry: ChiCTR1800020107.

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The effect and mechanism of YH0618 granule on chemotherapy- induced hair loss in patients with breast cancer: study protocol for a randomized, double-blind, multi-center clinical trial

Trials ◽

10.1186/s13063-019-3893-3 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Jie-shu You ◽

Li Guo ◽

Mei Huang ◽

Xin-lei Shi ◽

Man-di Lin ◽

...

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Clinical Trial ◽

Cancer Patients ◽

Hair Loss ◽

Double Blind ◽

Kidney Deficiency ◽

Group A ◽

Group B

Abstract Background Hair loss is one of the most common side effects of chemotherapy, and can cause persistent negative emotions, further affecting therapeutic effects and reducing the quality of life. However, there are no clinically safe and effective methods to solve the problem at present. Our previous clinical and animal studies showed that a medicinal and edible decoction, YH0618, could significantly promote hair growth in cancer patients after chemotherapy, without interfering with the anti-tumor effects of chemotherapy. Besides, the theory of Chinese Medicine believes that the “Essence of the kidney is reflected on the hair”. Therefore, this study will further explore the efficacy of YH0618 granule on chemotherapy-induced hair loss in patients with breast cancer by a randomized, double-blind, multi-center clinical trial and elucidate the potential mechanism from the aspect of kidney deficiency or renal dysfunction. Methods/design Eligible breast cancer patients who will start chemotherapy will be randomly divided into group A (YH0618 granule) and group B (placebo). The chemotherapeutic agents contain taxanes or/and anthracyclines, and the chemotherapy regimen will be for at least six cycles with a cycle every 3 weeks. Subjects assigned to group A will receive YH0618 granules twice a day (6 g each time), 6 days a week, mixed with 300 ml warm water from the first to the fourth chemotherapy cycle. Subjects in group B will receive the placebo granule in the same manner. The primary outcome is the time point of occurrence of hair loss reaching grade II as assessed by the WHO Toxicity Grading Scale, and objective indices of hair quality and hair-follicle growth recorded by a hair and scalp detector before the fifth chemotherapy cycle. Secondary outcomes include changes of facial color and thumbnail color, grading of thumbnails ridging, assessment of quality life, level of fatigue, routine blood test results, hepatic and renal function, and certain medical indicators which can reflect kidney deficiency in Chinese Medicine. Discussion This research is of great significance for the treatment of cancer and improving the quality of life of cancer patients. The study may provide the most direct evidence for meeting clinical needs and lay a solid scientific foundation for later product development. Trial registration Chinese Clinical Trial Registry, ID: ChiCTR1800020107. Registered on 14 December 2018.

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A COMPARISON BETWEEN INTRATHECAL NALBUPHINE VERSUS FENTANYL AS AN ADJUVANT WITH 0.5% HYPERBARIC BUPIVACAINE FOR POSTOPERATIVE ANALGESIA IN PATIENTS UNDERGOING LOWER SEGMENT CESAREAN SECTION

International Journal of Medical and Biomedical Studies ◽

10.32553/ijmbs.v5i8.2081 ◽

2021 ◽

Vol 5 (8) ◽

Author(s):

Mukesh Choudhary ◽

Neeti Mahla

Keyword(s):

Cesarean Section ◽

Postoperative Analgesia ◽

Motor Block ◽

Sensory Block ◽

Hyperbaric Bupivacaine ◽

Double Blind ◽

Lower Segment Cesarean Section ◽

Group A ◽

The Mean ◽

Group B

Background: Subarachnoid block is the preferred anesthesia for cesarean section, being simple to perform and economical with rapid onset. This study aims to compare the postoperative analgesia of intrathecal nalbuphine and fentanyl as adjuvants to bupivacaine in cesarean section. Methods: A prospective, randomized, double?blind, and comparative study was conducted on 120 patients of American Society of Anesthesiologists (ASA) physical status I and II. These patients were randomized into three groups with fifty patients in each group. Group A received 2 ml of 0.5% hyperbaric bupivacaine (10 mg) plus 0.4 ml nalbuphine (0.8 mg), Group B received 2 ml of 0.5% hyperbaric bupivacaine (10 mg) plus 0.4 ml fentanyl (20 ?g), and Group B received 2 ml of 0.5% hyperbaric bupivacaine (10 mg) plus 0.4 ml of normal saline. Results: The mean duration of sensory block was 107.32 ± 5.36 min in Group A, 111.23 ± 4.23 min in Group B, and 85.69 ± 2.31 min in Group C. The mean duration of motor block (time required for motor block to return to Bromage’s Grade 1 from the time of onset of motor block) was 152.02 ± 3.12 min in Group A, 151.69± 2.36 min in Group B, and 122.12 ± 2.32 min in Group C. Conclusion: We concluded that intrathecal nalbuphine prolongs postoperative analgesia maximally and may be used as an alternative to intrathecal fentanyl in cesarean section. Keywords: Nalbuphine, Bupivacaine, Fentanyl.

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COMPARISON OF DEXMEDETOMIDINE AND FENTANYL ON INTUBATION CONDITIONS DURING AWAKE FIBREOPTIC BRONCHOSCOPIC INTUBATION- A RANDOMISED DOUBLE BLIND STUDY.

10.36106/ijar/9009785 ◽

2021 ◽

pp. 1-2

Author(s):

Asha .A ◽

E. Arunmozhi

Keyword(s):

Heart Rate ◽

Study Drug ◽

Sedation Score ◽

Double Blind ◽

Group A ◽

The Mean ◽

Group B ◽

Post Intubation ◽

Ramsay Sedation Score ◽

Mean Heart Rate

INTRODUCTION:Awake Fibreoptic Intubation is indicated in patients with anticipated diffcult airway, failed tracheal intubation, unstable cervical spine injury.Drugs used for conscious sediation includes Benzodiazepines, opioids, Propofol, either alone or in combination. All these drugs, though results in favourable intubating conditions, may also result in upper airway obstruction, hypoventilation, difcult airway instrumentation and oxygen desaturation. In order to address and overcome these issues, we compared the effects of parenteral dexmedetomidine and fentanyl on favourable conditions during awake breoptic bronchoscopic intubation. MATERIALS AND METHODS:A prospective,double blind,randomised study. 60 patients belonging to age group 25 to 60 years, ASA PS I & II posted for elective surgery under general anaesthesia with endotracheal intubation were randomly allocated into two groups, Group A(n=30) received injection dexmedetomidine, Group B(n=30) received injection fentanyl before awake breoptic bronchoscopic intubation. Hemodynamic parameters, cough score, postintubation tolerance score, ramsay sedation score were noted in both groups. The observed datas were analysed by SPSS version 21.0 software. RESULT: Demographic variable such as age,weight,ASA physical status were comparable in both the groups. The mean heart rate at 5mins,10mins after administration of study drug,intubation, 5mins postintubation are 76.73±5.51,73.63±5.99,76.37±8.11 and 75.03±7.94 respectively in Group A.The mean heart rate at 5mins,10mins after administration of study drug,intubation, 5mins postintubation are 78.57±5.04,76.93±5.11,103.30±4.21 and 99.37±4.02 respectively.The mean MAP at 5mins,10 mins after administration of study drug,intubation,5 mins post intubation are 86.80±2.33,85.77 ±2.56,87.83 ±5.73 and 87.30 ± 2.52mmHg respectively in Group A.The mean MAP at 5mins,10mins after administration of study drug,intubation,5 mins post intubation are 87.37±3.58,85.63 ±3.58,107.80 ±2.59 and 105.00 ±2.52 mmHg respectively. The post intubation SpO2 was 97.10 ±1.77 and 93.43± 1.17 % for Group A and Group B respectively.In Group A mean Ramsay sedation score is 2.87± 0.43 and in Group B the mean is 2.13 ±0.35. CONCLUSION:Dexmedetomidine group showed better hemodynamic stability and tolerance to awake endotracheal tube insertion through breoptic bronchoscope.Dexmedetomidine provides favourable intubating conditions during awake breoptic bronchoscope procedures with adequate sedation and without desaturation than fentanyl.

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Randomized Trial of Silver Nitrate with Sodium Fluoride for Caries Arrest

JDR Clinical & Translational Research ◽

10.1177/2380084418818482 ◽

2019 ◽

Vol 4 (2) ◽

pp. 126-134 ◽

Cited By ~ 7

Author(s):

S.S. Gao ◽

D. Duangthip ◽

M.C.M. Wong ◽

E.C.M. Lo ◽

C.H. Chu

Keyword(s):

Clinical Trial ◽

Preschool Children ◽

Silver Nitrate ◽

Randomized Clinical Trial ◽

Sodium Fluoride ◽

Silver Diamine Fluoride ◽

Group A ◽

The Mean ◽

The Difference ◽

Group B

Objectives: The aim of this noninferiority double-blind randomized clinical trial was to compare the effectiveness of the topical semiannual application of a 25% silver nitrate (AgNO3) solution followed by a 5% sodium fluoride (NaF) varnish with that of a 38% silver diamine fluoride (SDF) solution in arresting caries among preschool children. Methods: Healthy 3-y-old children with active dentine carious lesions were randomly allocated to 2 groups via computer-generated random numbers. Lesions in group A received applications of a 25% AgNO3 solution followed by a 5% NaF varnish semiannually (every 6 mo). Lesions in group B received semiannual applications of a 38% SDF solution followed by a placebo varnish. A trained examiner recorded the status of caries and oral hygiene at baseline and during follow-up examinations. The examiner, children, and their caretakers were blinded to the intervention allocation. This study adopted an intention-to-treat analysis. A noninferiority test was conducted for the data analysis. Group A’s noninferiority was accepted if the lower limit of the 95% CI for the difference in the mean number of arrested surfaces was >−0.5. Results: A total of 1,070 children were recruited at baseline, with 535 children in each group. After 18 mo, the mean ± SD number of arrested surfaces was 3.3 ± 3.4 in group A (n = 484) and 3.2 ± 3.5 in group B (n = 476; P = 0.664). The difference in the mean number of arrested surfaces between the groups was 0.092 (95% CI, −0.322 to 0.505). Apart from black staining on the arrested lesions, no other significant side effect was observed. Conclusion: A semiannual application of 25% AgNO3 followed by 5% NaF is no worse than a 38% SDF in arresting dentine caries among preschool children over 18 mo. The Hong Kong Research Grants Council (GRF 17107315) funded this trial, which was registered at ClinicalTrials.gov (NCT02019160). Knowledge Transfer Statement: This randomized clinical trial found that silver nitrate solution followed by sodium fluoride varnish is effective in arresting dentine caries among preschool children. As silver nitrate followed by sodium fluoride is a noninvasive and simple protocol, it can be an alternative strategy to manage dental caries among young children, especially in countries where silver diamine fluoride is not available.

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