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

NCT04207450 | Completed

• 1 other identifier: UFPara-006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentin Sensitivity

Keywords

Clinical trials; Dentin Sensitivity; glutaraldehyde; Desensitizing agents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Dentin hypersensitivity experience questionnaire

  Immediately after the intervention

Study Arms (3)

Placebo Group

PLACEBO COMPARATOR

Placebo Gel + Placebo Solution (Distilled Water)

Other: Placebo gel

Placebo Gel + Glutaraldehyde (GPG)

EXPERIMENTAL

Placebo Gel + 5% Glutaraldehyde Aqueous Solution

Other: Placebo Gel + 5% Glutaraldehyde Aqueous Solution

Phosphoric Acid + Glutaraldehyde (GAG)

EXPERIMENTAL

37% Phosphoric Acid + Glutaraldehyde Aqueous Solution (GAG)

Other: Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5%

Interventions

Placebo gel OTHER

Placebo gel application followed by placebo solution application (distilled water)

Placebo Group

Placebo Gel + 5% Glutaraldehyde Aqueous Solution OTHER

Placebo gel followed by 5% aqueous glutaraldehyde solution

Placebo Gel + Glutaraldehyde (GPG)

Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5% OTHER

37% phosphoric acid application followed by 5% aqueous glutaraldehyde solution

Phosphoric Acid + Glutaraldehyde (GAG)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Presence of gingival recession without or with periodontal pocket up to 5mm probing depth, which presented painful sensitivity response to tactile and evaporative stimuli.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Para: lead

Study Sites (1)

Federal University of Para

Belém, Pará, 66075-110, Brazil

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

phosphoric acid

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 20, 2019
• Study Start: March 15, 2019
• Primary Completion: November 29, 2019
• Study Completion: December 13, 2019
• Last Updated: April 21, 2020

Record last verified: 2020-04

Locations

BR (1)