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

Dentin Sensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04207450
• Other study ID #: UFPara-006
• Status: Completed
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: December 13, 2019

Study information

• Verified date: April 2020
• Source: Universidade Federal do Para
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 13, 2019
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity

Intervention

Other:
• Placebo gel
Placebo gel application followed by placebo solution application (distilled water)
• Placebo Gel + 5% Glutaraldehyde Aqueous Solution
Placebo gel followed by 5% aqueous glutaraldehyde solution
• Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5%
37% phosphoric acid application followed by 5% aqueous glutaraldehyde solution

Locations

Country	Name	City	State
Brazil	Federal University of Para	Belém	PA

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Para

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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