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

Not Applicable

Completed

• Conditions: Dentin Sensitivity
• Interventions: Other: Placebo gel; Other: Placebo Gel + 5% Glutaraldehyde Aqueous Solution; Other: Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5%

• Registration Number: NCT04207450
• Lead Sponsor: Universidade Federal do Para

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-15
• Primary Completion: 2019-11-29
• Study Completion: 2019-12-13
• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-19
• Study First Posted: 2019-12-20
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-18
• Last Update Posted: 2020-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo gel	Placebo Gel + Placebo Solution (Distilled Water)
Placebo Gel + Glutaraldehyde (GPG)	Placebo Gel + 5% Glutaraldehyde Aqueous Solution	Placebo Gel + 5% Glutaraldehyde Aqueous Solution
Phosphoric Acid + Glutaraldehyde (GAG)	Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5%	37% Phosphoric Acid + Glutaraldehyde Aqueous Solution (GAG)

Primary Outcome Measures

Name	Time	Method
Dentin sensitivity	Immediately after the intervention	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.

Secondary Outcome Measures

Name	Time	Method
Dentin hypersensitivity experience questionnaire	Immediately after the intervention	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.

Trial Locations

Locations (1)

Federal University of Para; 🇧🇷 Belém, PA, Brazil