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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • PA
    • Belém, PA, Brazil, 66075-110
      • Federal University of Para

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo Group; Placebo Gel + Placebo Solution (Distilled Water)	Other: Placebo gel; Placebo gel application followed by placebo solution application (distilled water)
EXPERIMENTAL: Placebo Gel + Glutaraldehyde (GPG); Placebo Gel + 5% Glutaraldehyde Aqueous Solution	Other: Placebo Gel + 5% Glutaraldehyde Aqueous Solution; Placebo gel followed by 5% aqueous glutaraldehyde solution
EXPERIMENTAL: Phosphoric Acid + Glutaraldehyde (GAG); 37% Phosphoric Acid + Glutaraldehyde Aqueous Solution (GAG)	Other: Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5%; 37% phosphoric acid application followed by 5% aqueous glutaraldehyde solution

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidade Federal do Para

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 15, 2019
• Primary Completion (ACTUAL): November 29, 2019
• Study Completion (ACTUAL): December 13, 2019

Study Registration Dates

• First Submitted: December 16, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (ACTUAL): December 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 18, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Dentin Sensitivity; Clinical trials; Desensitizing agents; glutaraldehyde
• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity; Anti-Infective Agents; Disinfectants; Glutaral
• Other Study ID Numbers: UFPara-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No