Guidelines for the design and conduct of clinical trials on dentine hypersensitivity*

Abstract

Clinical trials on dentine hypersensitivity have been numerous and protocols varied. To date there is little consensus as to the conduct of studies on this poorly-understood yet common and painful dental condition. A committee of interested persons from academia and industry was convened to discuss the subject of clinical trials on dentine hypersensitivity and a consensus report is presented. A double-blind randomized parallel groups design is recommended, although cross-over designs may be used for the preliminary screening of agents. Subjects may have multiple sites scored. Sample size will be determined by estimating the variability in the study population, the effect to be detected and the power of the statistical test to be used. Subject selection is based on a clinical diagnosis of dentine hypersensitivity, excluding those with conflicting characteristics such as currently-active medical or dental therapy. The vestibular surfaces of incisors, cuspids and bicuspids are preferred as sites to be tested. A range of sensitivity levels should be included. Tactile, cold and evaporative air stimuli should be applied. Negative and benchmark controls should be incorporated. Most trials should last 8 weeks. Sensitivity may be assessed either in terms of the stimulus intensity required to evoke pain or the subjective evaluation of pain produced by a stimulus using a visual analog or other appropriate scale. The subject's overall assessment may be determined by questionnaire. Outcomes should be expressed in terms of clinically significant changes in symptoms. Follow-up evaluation is required to determine the persistence of changes. At least 2 independent trials should be conducted before a product receives approval.

A CLINICAL COMPARISON of IN -OFFICE MANAGEMENT OF DENTIN HYPERSENSITIVITY IN A SHORT TERM TREATMENT PERIOD

“…Gluma Desensitizer contains hydroxy-ethylmethacrylate (HEMA) with glutaraldehyde resulting in its desensitizing effect by precipitation of plasma proteins in the dentinal tubules which reduces dentinal permeability and occludes the peripheral tubules. In the reaction of glutaraldehyde with dentin, the two groups of aldehydes present in glutaraldehyde interlace themselves with the amino groups of dentin collagen, leading to a fixing of proteins, forming a barrier 13 .The positive results of Gluma Desensitizer presented in this study are in agreement with the results of similar studies carried out earlier 14,15 .After 2 weeks the effectiveness of gluma was better than GC tooth mousse as repeated application of GC is required for its effectiveness. Thus stating that its treatment is short lived requiring a home based treatment too.…”

“…Because it is an unstable compound, CaF2 rapidly dissociates after application, so that the anti-hyperesthesia effect is of short duration 13 . In spite of fluoride being recognized as an effective anti-caries agent, its use as a desensitizing agent is still reported as unsuccessful when compared to therapeutic agents such as Clinpro ,GC tooth mousse & Gluma, despite its distinct modes of action.…”

Strontium effects on root dentin tubule occlusion and nanomechanical properties

“…Teeth were sterilized by gamma radiation and stored in Hank's balanced salt solution (HBSS) until used [24]. Hypersensitivity most commonly presents on buccal cervical surfaces of permanent teeth thus those areas are recommended for clinical studies [25]. We elected to use the root dentin to meet the same recommendation.…”

Dentin hypersensitivity after treatment with desensitizing agents: a randomized, double-blind, split-mouth clinical trial

“…Placebo control is defined as a formulation containing no ingredients expected to have or proven to be of therapeutic value in dentin hypersensitivity (19). Although the placebo formulation consists of inert substances, the hypothesis of a mechanical tubule occlusion by the carboxymethylcellulose particles cannot be discarded (7).…”