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Randomised clinical studies investigating immediate and short-term efficacy of an occluding toothpaste in providing dentine hypersensitivity relief.

ABSTRACT: BACKGROUND:Dentine hypersensitivity (DH) can occur after gum recession or enamel loss and may impact quality of life. Treatments include toothpastes that decrease DH by occluding dentine tubules. One effective occluding ingredient used in toothpastes is stannous fluoride (SnF2), but this can be unstable in aqueous formulation. These three studies aimed to characterise the short-term effects of an experimental, anhydrous SnF2 dentifrice on DH. METHODS:Three examiner-blind, parallel-group studies evaluated DH in participants with the condition after a single brushing and after 3d brushing with an experimental anhydrous 0.454% SnF2/polyphosphate toothpaste (Test) or a toothpaste containing 0.76% sodium monofluorophosphate (Control). Test treatment participants brushed two pre-identified sensitive teeth first, then their remaining dentition for ?1?min ('focused brushing'). Control treatment participants brushed their whole dentition for ?1?min. DH was measured after single brushing and after 3d twice-daily use, via evaporative (air) (Schiff Sensitivity Scale) and tactile (Yeaple probe) stimuli and analysed using an ANCOVA model. RESULTS:In all studies, after 3d treatment, the Test toothpaste/brushing regimen significantly reduced DH compared to the Control regimen by both evaporative and tactile stimuli assessment (p

SUBMITTER: Creeth J

PROVIDER: S-EPMC6549378 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Randomised clinical studies investigating immediate and short-term efficacy of an occluding toothpaste in providing dentine hypersensitivity relief.

Creeth Jonathan J Gallob John J Sufi Farzana F Qaqish Jimmy J Gomez-Pereira Paola P Budhawant Chandrashekhar C Goyal Chhaju C

BMC oral health 20190604 1

<h4>Background</h4>Dentine hypersensitivity (DH) can occur after gum recession or enamel loss and may impact quality of life. Treatments include toothpastes that decrease DH by occluding dentine tubules. One effective occluding ingredient used in toothpastes is stannous fluoride (SnF<sub>2</sub>), but this can be unstable in aqueous formulation. These three studies aimed to characterise the short-term effects of an experimental, anhydrous SnF<sub>2</sub> dentifrice on DH.<h4>Methods</h4>Three ex ...[more]

PMID: 31164116

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Project description:BACKGROUND:Dentine hypersensitivity can impact functional status and everyday activities such as eating and talking. This study aimed to assess changes in oral health-related quality of life measures in individuals with dentine hypersensitivity following long-term use (24 weeks) of a commercially available toothpaste marketed for dentine hypersensitivity relief. METHODS:This study was conducted across two sites and enrolled 75 adults with ≥2 non-adjacent sensitive teeth. Participants were assigned to twice-daily brushing with toothpaste containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Every 4 weeks, participant-reported outcomes were assessed using the Dentine Hypersensitivity Experience Questionnaire (DHEQ), a condition specific oral health-related quality of life scale that has five domains and includes questions on social and emotional impact, restrictions, adaptations and effect on life overall. Responses to a clinically applied evaporative (air) stimulus were assessed using the examiner-observed Schiff sensitivity scale and Labelled Magnitude Scales (LMS), which included dentine hypersensitivity-specific descriptors of intensity, duration, tolerability and descriptive qualities of the participant's response. RESULTS:Participant-reported outcomes demonstrated reduction of the impact of dentine hypersensitivity over time on health-related quality of life, as measured by the DHEQ. This reached statistical significance from Week 8 onwards (p < 0.0001 versus baseline) for the Total DHEQ score, with scores continually decreasing at each timepoint. Most domain scores followed a similar pattern. Statistically significant reductions were also detected for the examiner-observed Schiff Sensitivity Scale scores at all timepoints (including at 4 weeks) (p < 0.05), which were mirrored by LMS responses. The toothpaste was generally well-tolerated. CONCLUSIONS:These results show that long-term use of a sensitivity toothpaste containing 0.454% w/w stannous fluoride has a beneficial, ongoing, impact on the oral health-related quality of life of people with dentine hypersensitivity. TRIAL REGISTRATION:This study was registered at Clinicaltrials.gov ( https://clinicaltrials.gov/ct2/show/NCT02752958 ) on April 27, 2016.

Project description:BackgroundDentine hypersensitivity (DH) could occur or intensify after non-surgical periodontal therapy because of the exposure of dentine tubules, but currently no gold standard exists to treat DH. It has been demonstrated that nano-sized particles presented potential for dentine tubules blocking and remineralization. This randomized controlled trial aimed to investigate the efficacy of dentifrice containing nano-carbonate apatite (n-CAP) in reducing dentine hypersensitivity (DH) after non-surgical periodontal therapy.Methods48 periodontitis patients with DH were included in this clinical trial. After non-surgical periodontal therapy, patients included were randomized to test and control group and the respective dentifrices were applied at chairside, after which they were instructed to brush teeth with the allocated dentifrices twice a day at home. Periodontal parameters were recorded at baseline and the last follow-up. DH was measured by air-blast test and recorded by visual analogue scale (VAS) and Schiff sensitivity scale at baseline, after polishing (0 week) and 2/4/6 weeks.Results45 participants completed the follow-up. Periodontal parameters were improved and comparable between groups. Significant reduction in DH was observed in both groups at all time-points compared to baseline in terms of VAS and Schiff score. The test group achieved significantly greater relief from hypersensitivity compared with the control group after 4-week at-home use (for change of VAS, test group: 2.27 ± 2.47 versus control group: 1.68 ± 2.24, p = 0.036; for change of Schiff, test group: 0.94 ± 0.92 versus control group: 0.61 ± 0.83, p < 0.001). The 6-week results showed borderline significance between groups in terms of change of Schiff (p = 0.027) and no significance in terms of change of VAS (p = 0.256).ConclusionsHome-use of n-CAP based dentifrice had some benefit on alleviation of DH following non-surgical periodontal therapy after 4 weeks compared to the control product.Trial registrationChinese Clinical Trials Registry (No. ChiCTR-IPR-17011678, http://www.chictr.org.cn/, registered 16 June, 2017).

Project description:BackgroundThis examiner-blind, stratified, parallel study aimed to evaluate the anti-gingivitis efficacy of a non-aqueous (anhydrous) 0.454% w/w stannous fluoride toothpaste ('Test') versus a sodium monofluorophosphate toothpaste ('Control') in people with clinically-confirmed mild-moderate gingivitis. Plaque-induced gingivitis can progress to irreversible periodontitis if left untreated. This can be controlled by an effective oral hygiene regimen such as one including toothbrushing with a toothpaste containing the chemotherapeutic agent stannous fluoride. Long-term studies over 4-12 weeks have shown the efficacy of stannous fluoride; however, shorter term studies are needed to examine if the effects on measures of gingivitis and plaque control occur sooner.MethodsEligible participants were randomised to 3 weeks' twice-daily brushing (for 1 min) with Test or Control toothpastes. The primary efficacy variable was between-treatment difference in Bleeding Index (BI) at 3 weeks; secondary variables were between-treatment differences in number of bleeding sites, modified Gingival Index (MGI), and Turesky modification of the Quigley-Hein Plaque Index (TPI) at Weeks 2 and 3.ResultsA statistically significant (p < 0.0001) lower BI score was reported for Test (n = 65) versus Control (n = 65) groups at Week 2 (mean difference: - 0.07 [95% CI - 0.9, - 0.05]; 32.7% difference) and Week 3 (mean difference: - 0.06 [95% CI - 0.8, - 0.04]; 29.2% difference). The Test group also demonstrated statistically significant lower (all p < 0.0001 versus Control) number of bleeding sites (Weeks 2/3 mean difference [95% CI]: - 10.04 [- 12.3, - 7.5]/ - 8.2 [- 11.1, - 5.3] sites; 33.0%/29.3% difference); MGI score (Weeks 2/3 mean difference [95% CI]: - 0.09 [- 0.13, - 0.06]/ - 0.10 [- 0.14, - 0.06]; 4.3%/4.7% difference); overall TPI score (Weeks 2/3 mean difference [95% CI]: - 0.45 [- 0.55, - 0.35/ - 0.42 [- 0.53, - 0.30] difference; 16.0%/15.1% difference) and interproximal TPI score (Weeks 2/3 mean difference [95% CI]: - 0.42 [- 0.52, - 0.30]/ - 0.41 [- 0.52, - 0.29]; 14.6%/14.1% difference). Both toothpastes were generally well tolerated.ConclusionThree weeks' twice-daily brushing with the 0.454% w/w stannous fluoride Test toothpaste compared to the Control toothpaste led to statistically significant lower gingival bleeding, gingival inflammation and plaque levels in adults with mild-moderate gingivitis. These results indicate that plaque and gingivitis-reducing benefits of 0.454% w/w stannous fluoride may be seen from 2 weeks' use. Trial registration ClinicalTrials.gov Identifier: NCT04050722; 08/08/2019.

Project description:BackgroundDentine hypersensitivity on an exposed root surface induces pain, affects daily oral hygiene practice, limits dietary choices and negatively affects quality of life. Silver diamine fluoride is marketed in the United States as a desensitising agent, but well-designed clinical trials are limited. This study evaluates the anti-hypersensitivity effect of silver diamine fluoride on hypersensitive teeth due to an exposed root surface in older Chinese adults.Methods/designWe will conduct a randomised double-blind clinical trial with a sample size of at least 148 Chinese older adults aged 65 or above who have dentine hypersensitivity due to an exposed root surface. We will collect written consent before the study. A trained examiner will examine the participants' teeth with a blast of compressed air from a 3-in-1 syringe. Those adults who report a self-perceived sensitivity score (SS) (0 to 10) of 8 or more on at least one tooth with an exposed root surface will be recruited. The recruited older adults will be randomly allocated into two groups using a block randomisation of six. Group 1 participants will receive the application of 38% silver diamine fluoride solution every 4 weeks. Group 2 participants will receive the application of 5% potassium nitrate solution every 4 weeks. Dietary advice, oral hygiene instruction and fluoride toothpaste at 1450 ppm will be provided to participants in both groups. The same trained examiner will perform follow-up examinations for the participants and determine the dentine hypersensitivity in SS of the most hypersensitive tooth (with the highest pre-treatment SS) immediately after the intervention and at 4-week and 8-week intervals.DiscussionThere is no consensus on the standard of care for a professionally applied desensitising agent in older adults. This trial will provide evidence for clinicians to devise an effective dental care plan for older adults with dentine hypersensitivity.Trial registrationNCT05392868 Registered on 22 May 2022.

Dataset Information

Randomised clinical studies investigating immediate and short-term efficacy of an occluding toothpaste in providing dentine hypersensitivity relief.

Publications

Randomised clinical studies investigating immediate and short-term efficacy of an occluding toothpaste in providing dentine hypersensitivity relief.

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