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

NCT ID: NCT04207450

Last Updated: 2020-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-15
• Study Completion Date: 2019-12-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo Group

Placebo Gel + Placebo Solution (Distilled Water)

Group Type: PLACEBO_COMPARATOR

Placebo gel

Intervention Type: OTHER

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

Placebo Gel + Glutaraldehyde (GPG)

Placebo Gel + 5% Glutaraldehyde Aqueous Solution

Group Type: EXPERIMENTAL

Placebo Gel + 5% Glutaraldehyde Aqueous Solution

Intervention Type: OTHER

Placebo gel followed by 5% aqueous glutaraldehyde solution

Phosphoric Acid + Glutaraldehyde (GAG)

37% Phosphoric Acid + Glutaraldehyde Aqueous Solution (GAG)

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

Interventions

Placebo gel

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

Intervention Type: OTHER

Placebo Gel + 5% Glutaraldehyde Aqueous Solution

Placebo gel followed by 5% aqueous glutaraldehyde solution

Intervention Type: OTHER

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

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal do Para

OTHER

Sponsor Role: lead

Responsible Party

Cecy Martins Silva

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University of Para

Belém, Pará, Brazil

Countries

Brazil

Other Identifiers

UFPara-006

Identifier Type: -

Identifier Source: org_study_id