Mabi Singh

Caries clinical trial of a remineralising toothpaste in radiation patients

OBJECTIVES The purpose of this study was to determine the efficacy and safety of a specially formulated remineralising toothpaste in controlling caries in a high-risk population: head and neck radiation patients. DESIGN The study compared the performance of the remineralising toothpaste with a conventional fluoride dentifrice using double-blind randomisation. MATERIALS AND METHODS Test products: The products compared contained equivalent quantities of fluoride (1100 p.p.m.). The dual-phase remineralising toothpaste, Enamelon, also delivered soluble calcium and phosphate ions, essential components of teeth, from separate phases. Both groups had all caries restored at baseline and used a fluoride rinse daily. SUBJECTS Fifty-seven subjects who received radiation to the head and neck causing saliva hypofunction, entered the study, while 44 completed the 10-12 month visit. MEASUREMENTS Examinations included coronal and root caries using the Pitts Diagnostic Criteria, salivary flow rate, plaque and gingival indices and microbiological counts over a 1-year period. RESULTS The average net increment per year for root caries per subject was 0.04 (+/-.052) in subjects completing the study using the remineralising toothpaste and 1.65 (+/-0.51) for root caries in subjects completing the study using the conventional fluoride dentifrice. The difference was statistically significant (p = 0.03), suggesting lower net root surface increment/year for the remineralising toothpaste relative to the conventional toothpaste. No significant differences were noted on coronal surfaces. CONCLUSION The results indicate that the remineralising toothpaste provides a significant benefit in preventing and remineralising root caries in high-risk patients.

The oral mucosa as a therapeutic target for xerostomia

Autoimmune disorders, medical interventions, and aging are all known to be associated with salivary gland hypofunction, which results in the uncomfortable feeling of dry mouth (xerostomia) and significantly diminished oral health. The current therapeutic regimen includes increasing oral hydration using over-the-counter oral comfort agents and the use of systemic cholinergic drugs to stimulate salivary output. However, these approaches produce very transient relief or are associated with uncomfortable side-effects. Thus, new treatments that provide long-lasting relief from discomfort and improve oral health with minimal side-effects would benefit the therapy of this disease. The processes that mediate fluid loss from the oral cavity, such as the absorption of fluid from the oral mucosa, represent novel therapeutic targets for xerostomia. Preventing fluid absorption from the oral cavity is predicted to improve oral hydration and alleviate the clinical symptoms and discomfort associated with dry mouth. Furthermore, therapeutic strategies that prevent fluid absorption should complement current approaches that increase salivary output. This review discusses the current understanding of oral fluid balance and how these processes may be manipulated to provide relief for those suffering from dry mouth.

Efficacy of Chlorhexidine Varnish for the Prevention of Adult Caries A Randomized Trial

The Prevention of Adult Caries Study, an NIDCR-funded multicenter, double-blind, randomized clinical trial, enrolled 983 adults (aged 18-80 yrs) at high risk for developing caries (20 or more intact teeth and 2 or more lesions at screening) to test the efficacy of a chlorhexidine diacetate 10% weight per volume (w/v) dental coating (CHX). We excluded participants for whom the study treatment was contraindicated or whose health might affect outcomes or ability to complete the study. Participants were randomly assigned to receive either the CHX coating (n = 490) or a placebo control (n = 493). Coatings were applied weekly for 4 weeks and a fifth time 6 months later. The primary outcome (total net D1-2FS increment) was the sum of weighted counts of changes in tooth surface status over 13 months. We observed no significant difference between the two treatment arms in either the intention-to-treat or per-protocol analyses. Analysis of 3 protocol-specified secondary outcomes produced similar findings. This trial failed to find that 10% (w/v) chlorhexidine diacetate coating was superior to placebo coating for the prevention of new caries (Clinicaltrials.gov registration number NCT00357877).

Examiner Training and Reliability in Two Randomized Clinical Trials of Adult Dental Caries

OBJECTIVES This report describes the training of dental examiners participating in two dental caries clinical trials and reports the inter- and intra-examiner reliability scores from the initial standardization sessions. METHODS Study examiners were trained to use a modified International Caries Detection and Assessment System II system to detect the visual signs of non-cavitated and cavitated dental caries in adult subjects. Dental caries was classified as no caries (S), non-cavitated caries (D1), enamel caries (D2), and dentine caries (D3). Three standardization sessions involving 60 subjects and 3,604 tooth surface calls were used to calculate several measures of examiner reliability. RESULTS The prevalence of dental caries observed in the standardization sessions ranged from 1.4 percent to 13.5 percent of the coronal tooth surfaces examined. Overall agreement between pairs of examiners ranged from 0.88 to 0.99. An intra-class coefficient threshold of 0.60 was surpassed for all but one examiner. Inter-examiner unweighted kappa values were low (0.23-0.35), but weighted kappas and the ratio of observed to maximum kappas were more encouraging (0.42-0.83). The highest kappa values occurred for the S/D1 versus D2/D3 two-level classification of dental caries, for which seven of the eight examiners achieved observed to maximum kappa values over 0.90. Intra-examiner reliability was notably higher than inter-examiner reliability for all measures and dental caries classifications employed. CONCLUSION The methods and results for the initial examiner training and standardization sessions for two large clinical trials are reported. Recommendations for others planning examiner training and standardization sessions are offered.

Oral Implications of Polypharmacy in the Elderly

One of the major side effects of medications prescribed to elderly patients is the qualitative and quantitative alteration of saliva (salivary hypofunction). Saliva plays a pivotal role in the homeostasis of the oral cavity because of its protective and functional properties, including facilitating speech, swallowing, enhancing taste, buffering and neutralizing intrinsic and extrinsic acid, remineralizing teeth, maintaining the oral mucosal health, preventing overgrowth of noxious microorganisms, and xerostomia. With salivary hypofunction, a plethora of complications arise, resulting in decreased quality of life. The anticholinergic effects of medications can be overcome, and the oral cavity can be restored to normalcy.

Placebo-Controlled Clinical Trial of Use of 10% Hydrogen Peroxide Whitening Strips for Medication-Induced Xerostomia

Objective: A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the effectiveness and safety of peroxide-containing strip-based tooth whitening among subjects with medication-induced hyposalivation. Methods: Eligibility for this tooth whitening study was limited to dentate adults taking xerogenic medications with an unstimulated salivary flow ≤0.2 ml/min. After giving informed consent, 42 subjects were randomized using a 2:1 ratio to 10% hydrogen peroxide whitening strips (Crest® Whitestrips® Premium) or placebo strips without peroxide. Strips were used for 30 min twice daily for a 14-day period. Usage was unsupervised, and only the maxillary arch was treated. On days 8 and 15, efficacy was assessed from standard digital images of the anterior dentition and quantified using the Cielab color system, while safety was assessed from interviews and clinical examinations. Results: At day 8, the peroxide group experienced significant (p < 0.001) color improvement relative to baseline and placebo. Adjusted means ± standard errors for yellowness reduction were –1.65 ± 0.115 units for the peroxide group and –0.32 ± 0.170 units for the placebo group. For the increase in lightness, adjusted means ± standard errors on day 8 were 1.53 ± 0.130 units for the peroxide group and 0.37 ± 0.191 units for the controls. Continued strip use through day 15 yielded incremental color improvement for the peroxide group. Mild and transient tooth sensitivity represented the most common adverse events. No subject discontinued treatment due to a product-related adverse event. Conclusion: Twice daily use of 10% hydrogen peroxide whitening strips by adults with medication-induced xerostomia was well tolerated, with significant tooth color improvement evident within 7 days.

Predictors of coronal caries progression in adults: results from the Prevention of Adult Caries Study

OBJECTIVES This secondary analysis of data from the Prevention of Adult Caries Study (PACS) assesses risk factors for progression of coronal caries. METHODS Participants (n = 983) were adults at increased caries risk with at least one cavitated and one noncavitated lesions who were enrolled in a randomized clinical trial to test the effect of a 10% w/v chlorhexidine varnish coating on caries progression. Calibrated examiners scored tooth surfaces using a modified International Caries Detection and Assessment System (ICDAS) classification at baseline and at 7 and 13 months postrandomization. Potential baseline predictors of caries risk were used in adjusted negative binomial regression models to predict net D2FS increment and in linear regression models to predict the rank-normalized net D12FS increment. RESULTS Mean (SD) D2FS and D12FS increments were and 2.4 (3.1) and 2.1 (6.9), respectively. In multivariate analyses, two or more baseline D2 lesions, consumption of acidic drinks, and increasing age were all significantly associated with increased D2FS and D12FS risk. Daily flossing also was associated with increased D2FS risk. More frequent dental care at baseline was associated with significantly decreased caries risk for both increments. CONCLUSIONS The general concordance of risk factors in the D12FS and D2FS models lends support to the hypothesis that the D1 increment is an intermediate stage in the progression to fully cavitated lesions.