A Clinical Assessment of the Efficacy of a Stannous-Containing Sodium Fluoride Dentifrice on Dentinal Hypersensitivity

2010 ◽  
Vol 11 (1) ◽  
pp. 1-8 ◽  
Author(s):  
Tao He ◽  
Trevor Day ◽  
Johannes Einwag ◽  
Joachim S. Hermann ◽  
Mary Kay Anastasia ◽  
...  
Keyword(s):  
Sodium Fluoride ◽  
Clinical Assessment ◽  
Negative Control ◽  
Control Group ◽  
Lower Sensitivity ◽  
Double Blind ◽  
Parallel Group ◽  
Sensitive Teeth ◽  
Fluoride Dentifrice ◽  
Dentinal Hypersensitivity

Abstract Aim To measure the desensitizing benefits of an experimental stannous-containing sodium fluoride dentifrice versus a regular sodium fluoride negative control. Methods and Materials This study was a randomized, double-blind, parallel group, fourweek clinical trial. Subjects reporting dentinal hypersensitivity were enrolled and randomized to the experimental dentifrice or the control dentifrice to use twice daily for four weeks. Efficacy assessments (Air Blast) were performed at baseline and weeks two and four. Separate analyses were performed for the two most sensitive teeth at baseline and for all 12 teeth. Results for weeks two and four combined also were analyzed. Results Thirty-one subjects were included in the analyses. For the two most sensitive teeth, the experimental dentifrice showed statistically significantly less sensitivity (p<0.05) versus the control at weeks two and four and for weeks two and four combined. The sensitivity reduction ranged from 24.9% to 28.4% over the control. For all 12 teeth, the experimental group had statistically significantly (p<0.03) lower sensitivity scores versus the control group at week two and weeks two and four combined. Conclusion The experimental dentifrice demonstrated significant desensitizing advantages versus the control. Clinical Significance This stannouscontaining sodium fluoride dentifrice provides an effective treatment for patients with dentinal hypersensitivity, significantly reducing sensitivity versus a negative control in this four-week trial. Citation Day TN, Einwag J, Hermann JS, He T, Anastasia MK, Barker M, Zhang Y. A Clinical Assessment of the Efficacy of a Stannous- Containing Sodium Fluoride Dentifrice on Dentinal Hypersensitivity. J Contemp Dent Pract [Internet]. 2010 Jan; 11(1):001-008. Available from:http://www.thejcdp.com/journal/view/volume11- issue1-day.

scholarly journals A randomized, controlled, two-month pilot trial of stannous fluoride dentifrice versus sodium fluoride dentifrice after oxalate treatment for dentinal hypersensitivity

2020 ◽  
Vol 24 (11) ◽  
pp. 4043-4049
Author(s):  
Chad J. Anderson ◽  
Gerard Kugel ◽  
Yuanshu Zou ◽  
Marco Ferrari ◽  
Robert Gerlach
Keyword(s):  
Sodium Fluoride ◽  
Pilot Trial ◽  
Potassium Oxalate ◽  
Double Blind ◽  
Randomized Controlled ◽  
Stannous Fluoride ◽  
Fluoride Dentifrice ◽  
Professional Treatment ◽  
Dentinal Hypersensitivity ◽  
At Home

Abstract Objectives To compare the effects of a stannous fluoride dentifrice and a sodium fluoride dentifrice on dentinal hypersensitivity when used with an oxalate-based regimen combining in-office and at-home treatment. Materials and methods In this single-center, randomized, controlled, double-blind, pilot clinical trial, 30 subjects were professionally treated at baseline with a 3% oxalate/potassium salt solution on up to two target teeth, then randomized 1:1 to either 0.454% stannous fluoride or 0.243% sodium fluoride overlabeled dentifrice. Both groups were given 6 sensitivity strips (3.14% potassium oxalate gel) and a soft, manual toothbrush. Subjects were permitted to apply strips on up to two teeth, up to three times per tooth, at home as desired throughout the study. Dentinal sensitivity (cold air blast challenge) was assessed at baseline, immediately after post-professional treatment, and at day 60 using the Schiff scale and a Visual Analog Scale (VAS). Results Immediately after professional oxalate treatment, the overall mean Schiff and VAS score decreased 25.6% and 22.4% from baseline, respectively (p ≤ 0.001 for both). At day 60, further reductions in both mean scores were seen in both groups. There were no significant differences between the groups at day 60. All treatments were well tolerated. Conclusions In subjects treated with oxalates for dentinal hypersensitivity, both stannous fluoride and sodium fluoride dentifrices are well tolerated, are feasible for routine use, and do not detract from the desensitizing effects of an in-office and at-home oxalate combination treatment regimen. Clinical relevance Either stannous fluoride or sodium fluoride dentifrices can be recommended to dentinal hypersensitivity patients who undergo professional oxalate treatment.

scholarly journals Efficacy of an occluding toothpaste on dentinal hypersensitivity over 14 days

BDJ Open ◽  
2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Jonathan E. Creeth ◽  
Chhaju Goyal ◽  
Jimmy Qaqish ◽  
Robert Maclure ◽  
Jonathan S. Holt
Keyword(s):  
Study Design ◽  
Sodium Tripolyphosphate ◽  
Negative Control ◽  
Control Treatment ◽  
Efficacy Study ◽  
Parallel Group ◽  
Sensitive Teeth ◽  
And Control ◽  
Dentinal Hypersensitivity ◽  
Test Treatment

Abstract Objectives: To evaluate a 0.454% stannous fluoride/5% sodium tripolyphosphate (STP) toothpaste’s ability to provide relief from dentinal hypersensitivity (DH) applied using ‘focused brushing.’ Materials and methods: In two randomised, examiner-blind, parallel-group studies, a SnF2/STP toothpaste was applied by brushing two selected sensitive teeth before 1 min whole-mouth brushing, compared to 1 min whole-mouth brushing only, with a negative control toothpaste. DH was assessed via evaporative (air) (Schiff scale) and tactile (Yeaple probe) stimuli after 7 and 14 d of twice-daily brushing. Results: In total, 141 (Study 1)/142 (Study 2) participants were randomised. In Study 1, the test treatment significantly reduced DH at 7/14 d versus baseline (7/14 d Schiff difference: −0.74 [−0.84,−0.65]/−1.39 [−1.54,−1.23]; tactile: 6.00 [4.88,7.13]/15.30 [13.34,17.26]); whereas the Control treatment did not (7/14 d Schiff difference −0.03 [−0.13,0.06]/−0.10 [−0.25,0.06]; tactile: 0.77 [−0.36,1.90]/0.77 [−1.20,2.74]). Differences between Test and Control were statistically significant (p < 0.0001 all cases). In Study 2, both treatments reduced DH compared to baseline by both measures, but there were no significant between-treatment differences. Toothpastes were generally well-tolerated. Discussion and conclusions: Previous studies and Study 1 support SnF2/5% STP toothpaste efficacy; Study 2 results may have been influenced by placebo/Hawthorne effects. DH study design needs to, where possible, negate such effects.

Efficacy and Safety of a Novel Stabilized Stannous Fluoride and Sodium Hexametaphosphate Dentifrice for Dental Hypersensitivity

2006 ◽  
Vol 7 (2) ◽  
pp. 1-8 ◽  
Author(s):  
Thomas Schiff ◽  
Tao He ◽  
Lisa Sagel ◽  
Robert Baker
Keyword(s):  
Sodium Fluoride ◽  
Sodium Hexametaphosphate ◽  
Control Group ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Sensitivity Score ◽  
Stannous Fluoride ◽  
Air Index ◽  
The Mean ◽  
Dentinal Hypersensitivity

Abstract Purpose Dentinal hypersensitivity is a common complaint among dental patients. Recently, a novel 0.454% stabilized stannous fluoride dentifrice containing sodium hexametaphosphate (SHMP) was introduced that offers a desensitizing benefit. This trial was conducted to assess the desensitizing efficacy of this new dentifrice relative to a sodium fluoride control dentifrice. Methods and Materials This was a double-blind, parallel-group, randomized clinical trial conducted according to the American Dental Association (ADA) Guidelines for the Acceptance of Products for the Treatment of Dentinal Hypersensitivity. Ninety subjects who met the entrance criteria were stratified based on age, gender, and baseline sensitivity scores and randomly assigned to either the stabilized stannous fluoride + SHMP dentifrice (Crest® Pro-Health) or the sodium fluoride control dentifrice. Subjects were instructed to brush twice daily for eight weeks. Efficacy assessments were made, including tactile (Yeaple probe) and thermal (Schiff Air Index) sensitivity, and an oral soft tissue examination was conducted at baseline, week four, and week eight. Results The mean sensitivity score based on the Schiff Air Index for the stannous fluoride + SHMP group was statistically significantly lower than that of the control group, at both weeks four and eight (P < .0001). At week eight, the stannous fluoride + SHMP dentifrice group had an adjusted mean 44% lower than that of the control group. The mean tactile sensitivity score for the stannous fluoride + SHMP group was statistically significantly higher, indicating a reduction in sensitivity, than that of the control group, at both weeks four and eight (P < .0001). At week eight, the stannous fluoride + SHMP dentifrice group had a mean desensitizing improvement of 71% greater than the control. Conclusion The stabilized stannous fluoride + SHMP dentifrice provided statistically significant reductions in dentinal hypersensitivity at four and eight weeks compared to the sodium fluoride control dentifrice. Citation Schiff T, He T, Sagel L, Baker R. Efficacy and Safety of a Novel Stabilized Stannous Fluoride and Sodium Hexametaphosphate Dentifrice for Dentinal Hypersensitivity. J Contemp Dent Pract 2006 May;(7)2:001-008.

scholarly journals Short-Term Outcomes of Percutaneous Trephination with a Platelet Rich Plasma Intrameniscal Injection for the Repair of Degenerative Meniscal Lesions. A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study

2019 ◽  
Vol 20 (4) ◽  
pp. 856 ◽  
Author(s):  
Rafal Kaminski ◽  
Marta Maksymowicz-Wleklik ◽  
Krzysztof Kulinski ◽  
Katarzyna Kozar-Kaminska ◽  
Agnieszka Dabrowska-Thing ◽  
...  
Keyword(s):  
Platelet Rich Plasma ◽  
Meniscal Tear ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Non Union ◽  
Parallel Group ◽  
Significant Difference ◽  
Clinically Significant ◽  
Patient Related Outcome

Meniscal tears are the most common orthopaedic injuries, with chronic lesions comprising up to 56% of cases. In these situations, no benefit with surgical treatment is observed. Thus, the purpose of this study was to investigate the effectiveness and safety of percutaneous intrameniscal platelet rich plasma (PRP) application to complement repair of a chronic meniscal lesion. This single centre, prospective, randomized, double-blind, placebo-controlled study included 72 patients. All subjects underwent meniscal trephination with or without concomitant PRP injection. Meniscal non-union observed in magnetic resonance arthrography or arthroscopy were considered as failures. Patient related outcome measures (PROMs) were assessed. The failure rate was significantly higher in the control group than in the PRP augmented group (70% vs. 48%, P = 0.04). Kaplan-Meyer analysis for arthroscopy-free survival showed significant reduction in the number of performed arthroscopies in the PRP augmented group. A notably higher percentage of patients treated with PRP achieved minimal clinically significant difference in visual analogue scale (VAS) and Knee injury and Osteoarthritis Outcome Score (KOOS) symptom scores. Our trial indicates that percutaneous meniscal trephination augmented with PRP results in a significant improvement in the rate of chronic meniscal tear healing and this procedure decreases the necessity for arthroscopy in the future (8% vs. 28%, P = 0.032).

An Anticalculus Dentifrice with Sodium Hexametaphosphate and Stannous Fluoride: A Six-month Study of Efficacy

2007 ◽  
Vol 8 (5) ◽  
pp. 1-8 ◽  
Author(s):  
J. Leslie Winston ◽  
Thomas Schiff ◽  
Susan K. Fiedler ◽  
Robert A. Baker
Keyword(s):  
Soft Tissue ◽  
Home Care ◽  
Clinical Significance ◽  
Negative Control ◽  
Sodium Hexametaphosphate ◽  
Control Group ◽  
Stannous Fluoride ◽  
Parallel Group ◽  
Calculus Formation ◽  
Oral Soft Tissue

Abstract Aim To compare the anticalculus efficacy of an experimental dentifrice (0.454% stabilized stannous fluoride/ sodium hexametaphosphate) with a negative control. Methods and Materials This was a randomized, examiner-blind, parallel group study. After a three-month run-in, qualifying subjects were randomized to the experimental or control dentifrice to use twice a day for six months. Volpe-Manhold Index (V-MI) and oral soft tissue examinations were conducted at baseline, three, and six months. Additional analyses were performed separately at three and six months on three subgroups categorized into high, medium, and low calculus-forming subjects. Results Compared to the control group, the experimental dentifrice group had a mean calculus score statistically significantly lower at both three months (50%) and six months (55%) post-treatment (p<0.001). Compared to control scores, mean experimental dentifrice calculus scores at three and six months were statistically significantly lower at both points in time for high, medium, and low calculus forming sub-groups (p<0.001). Both products were generally well tolerated. Conclusion The experimental dentifrice revealed significant anticalculus efficacy compared to the control regardless of levels of baseline calculus formation. Clinical Significance The stannous fluoride/sodium hexametaphosphate dentifrice technology is an effective calculus inhibitor for home care. Citation Winston JL, Fiedler SK, Schiff T, Baker RA. An Anticalculus Dentifrice with Sodium Hexametaphosphate and Stannous Fluoride: A Six-month Study of Efficacy. J Contemp Dent Pract 2007 July;(8)5:001-008.

scholarly journals Gingivitis Efficacy of a 0.454% w/w Stannous Fluoride Dentifrice: A 24-week randomized controlled trial.

2020 ◽  
Author(s):  
Charles Richard Parkinson ◽  
Kimberly R MILLEMAN ◽  
Jeffery L MILLEMAN
Keyword(s):  
Treatment Group ◽  
Oral Hygiene ◽  
Controlled Trial ◽  
Negative Control ◽  
Periodontal Health ◽  
Stannous Fluoride ◽  
Dental Prophylaxis ◽  
Parallel Group ◽  
Fluoride Dentifrice ◽  
Adult Volunteers

Abstract Background: Plaque-induced gingivitis can be prevented and treated with regular effective oral hygiene, principally via mechanical cleaning with regular toothbrushing. To complement the mechanical plaque removal, antimicrobial ingredients can be incorporated into dentifrices to inhibit the growth of plaque. This study aimed to evaluate and compare gingivitis and the proportion of subjects moving between gingivitis severity (<10%, >10%<30%, >30% bleeding sites), and plaque reduction, following twice daily use of an experimental non-aqueous 0.454% weight/weight (w/w) stannous fluoride (SnF2) dentifrice, compared to a negative control dentifrice over 12 and 24 weeks. Method: This was a single-center, examiner-blinded, randomized, stratified, two-treatment arm, parallel group, 24-week clinical study in healthy adult volunteers with moderate gingivitis. At baseline, after abstaining from toothbrushing overnight, subjects underwent MGI (modified gingival index), BI (bleeding index) and PI (plaque index) assessments. Eligible subjects, who met the inclusion/exclusion criteria, were stratified based on gender and baseline mean MGI score (Low ≤2.00 /High >2.00) and randomized to treatment. Following randomization, subjects underwent a thorough dental prophylaxis and flossing. After 12 and 24 weeks of twice daily brushing with their allocated treatment, subjects returned to the site (with overnight plaque, having abstained from oral hygiene procedures for 8 hrs prior to visit) for MGI, BI and PI assessments. Treatment effect was evaluated by comparing the MGI, BI and PI scores. Results: One hundred and twenty-nine subjects were screened; 98 subjects were randomized and 90 subjects completed the study. Statistically significant differences between treatments, in favour of the 0.454% stannous fluoride dentifrice were observed, compared to the negative control dentifrice, for all outcome measures (MGI, BI, bleeding sites and PI at weeks 12 and 24 p<0.0001). At 24 weeks, 71% of subjects in the 0.453% SnF2 treatment group demonstrated <10% bleeding sites. Conclusion: A dentifrice containing 0.454% w/w SnF2 was shown to be superior to a standard dentifrice in controlling gingivitis and supra-gingival plaque, over a 24-week period. Over two thirds of subjects in the 0.454% SnF2 treatment group demonstrated a level of bleeding sites potentially representative of “clinical periodontal health” (<10%) following a dental prophylaxis and 24 weeks of product use.

scholarly journals Gingivitis Efficacy of a 0.454% w/w Stannous Fluoride Dentifrice: A 24-week randomized controlled trial.

2019 ◽  
Author(s):  
Charles Richard Parkinson ◽  
Kimberly R MILLEMAN ◽  
Jeffery L MILLEMAN
Keyword(s):  
Treatment Group ◽  
Oral Hygiene ◽  
Controlled Trial ◽  
Negative Control ◽  
Stannous Fluoride ◽  
Dental Prophylaxis ◽  
Parallel Group ◽  
Fluoride Dentifrice ◽  
Adult Volunteers ◽  
Dental Plaque Index

Abstract Background: Plaque-induced gingivitis can be prevented and treated with regular effective oral hygiene, principally via mechanical cleaning with regular toothbrushing. To complement the mechanical plaque removal, antimicrobial ingredients can be incorporated into dentifrices to inhibit the growth of plaque. This study aimed to evaluate and compare gingivitis, as measured by a modified gingival index (MGI), a bleeding index (BI), and oral hygiene, as assessed by a dental plaque index (PI), following twice daily use of an experimental non-aqueous 0.454% weight/weight (w/w) stannous fluoride (SnF2) dentifrice, compared to a negative control dentifrice over 12 and 24 weeks.Method: This was a single-center, examiner-blinded, randomized, stratified, two-treatment arm, parallel group, 24-week clinical study in healthy adult volunteers with moderate gingivitis. At baseline, after abstaining from toothbrushing overnight, subjects underwent MGI, BI and PI assessments. Eligible subjects, who met the inclusion/exclusion criteria, were stratified based on gender and baseline mean MGI score (Low ≤2.00 /High >2.00) and randomized to treatment. Following randomization, subjects underwent a thorough dental prophylaxis and flossing. After 12 and 24 weeks of twice daily brushing with their allocated treatment, subjects returned to the site (with overnight plaque, having abstained from oral hygiene procedures for 8 hrs prior to visit) for MGI, BI and PI assessments. Treatment effect was evaluated by comparing the MGI, BI and PI scores.Results: One hundred and twenty-nine subjects were screened; 98 subjects were randomized and 90 subjects completed the study. Statistically significant differences between treatments, in favour of the 0.454% stannous fluoride dentifrice were observed, compared to the negative control dentifrice, for all outcome measures (MGI, BI, bleeding sites and PI at weeks 12 and 24 p<0.0001). At 24, 71% of subjects in the 0.453% SnF2 treatment group demonstrated <10% of bleeding sites.Conclusion: A dentifrice containing 0.454% w/w SnF2 was shown to be superior to a standard dentifrice in controlling gingivitis and supra-gingival plaque, over a 24-week period. Over two thirds of subjects in the 0.454% SnF2 treatment group demonstrated a level of bleeding sites potentially representative of “clinical periodontal health” following a dental prophylaxis and 24 weeks of product use.

A Perioperative Course of Gabapentin Does Not Produce a Clinically Meaningful Improvement in Analgesia after Cesarean Delivery

2015 ◽  
Vol 123 (2) ◽  
pp. 320-326 ◽  
Author(s):  
David T. Monks ◽  
David W. Hoppe ◽  
Kristi Downey ◽  
Vibhuti Shah ◽  
Paul Bernstein ◽  
...  
Keyword(s):  
Cesarean Delivery ◽  
Analgesic Efficacy ◽  
Control Group ◽  
Double Blind ◽  
Meaningful Improvement ◽  
Analgesic Regimen ◽  
Parallel Group ◽  
Superiority Trial ◽  
Perioperative Course ◽  
To Receive

Abstract Background: Studies examining the efficacy of a single preoperative dose of gabapentin for analgesia after cesarean delivery (CD) have been inconclusive. The authors hypothesized that a perioperative course of gabapentin would improve analgesia after CD. Methods: This single-center, randomized, double-blind, placebo-controlled, parallel-group, superiority trial was designed to determine the analgesic efficacy of a perioperative course of gabapentin when added to a multimodal analgesic regimen. Women scheduled for elective CD during spinal anesthesia were randomized to receive a perioperative oral course of either gabapentin (600 mg preoperatively followed by 200 mg every 8 h for 2 days) or placebo. Postoperative pain was measured at 24 and 48 h, at rest and on movement, on a visual analogue scale (VAS, 0 to 100 mm). The primary outcome was pain on movement at 24 h. Neonatal outcomes, opiate consumption, VAS satisfaction (0 to 100 mm), adverse effects, and persistent pain were also assessed. Results: Baseline characteristics were similar between groups. There was a statistically significant but small reduction in VAS pain score (mean [95% CI]) on “movement” (40 mm [36 to 45] vs. 47 mm [42 to 51]; difference, −7 mm [−13 to 0]; P = 0.047) at 24 h in the gabapentin (n = 100) compared with control group (n = 97). There was more sedation in the gabapentin group at 24 h (55 vs. 39%, P = 0.026) but greater patient VAS satisfaction (87 vs. 77 mm, P = 0.003). Conclusions: A perioperative course of gabapentin produces a clinically insignificant improvement in analgesia after CD and is associated with a higher incidence of sedation.

Impact of a Potassium-enriched, Chloride-depleted 5% Glucose Solution on Gastrointestinal Function after Major Abdominopelvic Surgery

2016 ◽  
Vol 125 (4) ◽  
pp. 678-689 ◽  
Author(s):  
Lukas M. Löffel ◽  
Fiona C. Burkhard ◽  
Jukka Takala ◽  
Patrick Y. Wuethrich
Keyword(s):  
Renal Dysfunction ◽  
Radical Cystectomy ◽  
Urinary Diversion ◽  
Glucose Solution ◽  
Fluid Management ◽  
Disease Stage ◽  
Control Group ◽  
Double Blind ◽  
Parallel Group ◽  
End Stage

Abstract Background Gastrointestinal (GI) complications often delay recovery after radical cystectomy with urinary diversion. The authors investigated if perioperative administration of a potassium-enriched, chloride-depleted 5% glucose solution (G5K) accelerates recovery of GI function. Methods This randomized, parallel-group, single-center double-blind trial included 44 consecutive patients undergoing radical cystectomy and pelvic lymph node dissection with urinary diversion. Patients were randomized to receive either a G5K (G5K group) solution or a Ringer’s maleate solution (control group). Fluid management aimed for a zero fluid balance. Primary endpoint was time to first defecation. Secondary endpoints were time to normal GI function, need for electrolyte substitution, and renal dysfunction. Results Time to first defecation was not significantly different between groups (G5K group, 93 h [19 to 168 h] and control group, 120 h [43 to 241 h]); estimator of the group difference, −16 (95% CI, −38 to 6); P = 0.173. Return of normal GI function occurred faster in the G5K group than in the control group (median, 138 h [range, 54 to 262 h] vs. 169 h [108 to 318 h]); estimator of the group difference, −38 (95% CI, −74 to −12); P = 0.004. Potassium and magnesium were less frequently substituted in the G5K group (13.6 vs. 54.5% [P = 0.010] and 18.2 vs. 77.3% [P &lt; 0.001]), respectively. The incidence of renal dysfunction (Risk, Injury, Failure, Loss and End-stage kidney disease stage “risk”) at discharge was 9.1% in the G5K group and 4.5% in the control group; P = 1.000. Conclusions Perioperative administration of a G5K did not enhance first defecation, but may accelerate recovery of normal GI function, and reduces potassium and magnesium substitution after radical cystectomy and urinary diversion.

scholarly journals Gingivitis Efficacy of a 0.454% w/w Stannous Fluoride Dentifrice: A 24-week randomized controlled trial.

2020 ◽  
Author(s):  
Charles Richard Parkinson ◽  
Kimberly R MILLEMAN ◽  
Jeffery L MILLEMAN
Keyword(s):  
Treatment Group ◽  
Oral Hygiene ◽  
Controlled Trial ◽  
Negative Control ◽  
Periodontal Health ◽  
Stannous Fluoride ◽  
Dental Prophylaxis ◽  
Parallel Group ◽  
Fluoride Dentifrice ◽  
Adult Volunteers

Abstract Background: Plaque-induced gingivitis can be prevented and treated with regular effective oral hygiene, principally via mechanical cleaning with regular toothbrushing. To complement the mechanical plaque removal, antimicrobial ingredients can be incorporated into dentifrices to inhibit the growth of plaque. This study aimed to evaluate and compare gingivitis, proportion of subjects moving between gingivitis severity (<10%, >10%<30%, >30% bleeding sites) and oral hygiene, following twice daily use of an experimental non-aqueous 0.454% weight/weight (w/w) stannous fluoride (SnF2) dentifrice, compared to a negative control dentifrice over 12 and 24 weeks. Method: This was a single-center, examiner-blinded, randomized, stratified, two-treatment arm, parallel group, 24-week clinical study in healthy adult volunteers with moderate gingivitis. At baseline, after abstaining from toothbrushing overnight, subjects underwent MGI (modified gingival index), BI (bleeding index) and PI (plaque index) assessments. Eligible subjects, who met the inclusion/exclusion criteria, were stratified based on gender and baseline mean MGI score (Low ≤2.00/High >2.00) and randomized to treatment. Following randomization, subjects underwent a thorough dental prophylaxis and flossing. After 12 and 24 weeks of twice daily brushing with their allocated treatment, subjects returned to the site (with overnight plaque, having abstained from oral hygiene procedures for 8 hrs prior to visit) for MGI, BI and PI assessments. Treatment effect was evaluated by comparing the MGI, BI and PI scores. Results: One hundred and twenty-nine subjects were screened; 98 subjects were randomized and 90 subjects completed the study. Statistically significant differences between treatments, in favour of the 0.454% stannous fluoride dentifrice were observed, compared to the negative control dentifrice, for all outcome measures (MGI, BI, bleeding sites and PI at weeks 12 and 24 p<0.0001). At 24, 71% of subjects in the 0.453% SnF 2 treatment group demonstrated <10% of bleeding sites. Conclusion: A dentifrice containing 0.454% w/w SnF 2 was shown to be superior to a standard dentifrice in controlling gingivitis and supra-gingival plaque, over a 24-week period. Over two thirds of subjects in the 0.454% SnF 2 treatment group demonstrated a level of bleeding sites potentially representative of “clinical periodontal health” (<10%) following a dental prophylaxis and 24 weeks of product use.

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