Effect of Glutaraldehyde on Dentin Hypersensitivity After Non-surgical Periodontal Treatment

Study Overview
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Brief Summary
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This randomized, placebo-controlled, triple-blind trial aims to evaluate the effect of glutaraldehyde associated or not with 37% phosphoric acid conditioning on dentin hypersensitivity reduction after non-surgical periodontal treatment, and its durability after 15 and 30 days. desensitizing treatment. Additionally, investigate the impact of these treatments on health-related quality of life. The investigators selected patients who, after scraping and planing procedures, presented at least 2 teeth meeting the following inclusion criteria: presence of gingival recession without or with a periodontal pocket up to 5mm probing depth, which presented painful sensitivity response to tactile stimulus. and evaporative. Subjects were randomized into 3 groups: Placebo Group (GP) - Placebo Gel application followed by Placebo solution (distilled water); GPG- Placebo Gel application followed by application 5% aqueous glutaraldehyde solution; GSG - Application of 37% phosphoric acid followed by 5% aqueous glutaraldehyde solution. The sensitivity of the dental elements was evaluated by pain stimuli (tactile and evaporative) with the aid of a Visual Analog Scale (VAS). A questionnaire was applied to patients with the objective of capturing psychosocial experiences, prior to treatment and one month after its completion, to assess the impact of desensitizing treatment on health-related quality of life. Data will be collected and appropriate statistical tests will be applied.

Official Title
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Effect of Glutaraldehyde on Dentin Hypersensitivity After Non-surgical Periodontal Treatment: a Triple-blind Randomized Clinical Trial.

Conditions
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Dentin Sensitivity

Intervention / Treatment
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* Other: Placebo gel
* Other: Placebo Gel + 5% Glutaraldehyde Aqueous Solution
* Other: Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Presence of gingival recession without or with periodontal pocket up to 5mm probing depth, which presented painful sensitivity response to tactile and evaporative stimuli. Exclusion Criteria: Systemic diseases; Pulpitis; Carious lesions; Presence of restorations in selected teeth; Cracked enamel; Noncarious cervical lesions; Use of medication with analgesics and/or anti-inflammatories; Pregnant or lactating women; Desensitizing treatment and periodontal treatment received during three months prior to study recruitment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Group<br>Placebo Gel + Placebo Solution (Distilled Water) | Other: Placebo gel<br>* Placebo gel application followed by placebo solution application (distilled water)<br>|
| Experimental: Placebo Gel + Glutaraldehyde (GPG)<br>Placebo Gel + 5% Glutaraldehyde Aqueous Solution | Other: Placebo Gel + 5% Glutaraldehyde Aqueous Solution<br>* Placebo gel followed by 5% aqueous glutaraldehyde solution<br>|
| Experimental: Phosphoric Acid + Glutaraldehyde (GAG)<br>37% Phosphoric Acid + Glutaraldehyde Aqueous Solution (GAG) | Other: Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5%<br>* 37% phosphoric acid application followed by 5% aqueous glutaraldehyde solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dentin sensitivity | Evaluation of pain (dentin sensitivity) by applying tactile (exploratory probe pressure) and evaporative (air blast) stimuli on exposed dentin. Sensitivity will be measured using the Thomas Schiff scale from 0 to 3. Zero means absent dentin sensitivity and three means severe dentin sensitivity. | Immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dentin hypersensitivity experience questionnaire | A self-reported questionnaire was applied by the patients with the objective of capturing psychosocial experiences, previous treatment and one month after its completion, aiming to evaluate the impact of desensitizing treatment on health-related quality of life. | Immediately after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical trials, Dentin Sensitivity, glutaraldehyde, Desensitizing agents