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

Primary Purpose

Dentin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Placebo gel
Placebo Gel + 5% Glutaraldehyde Aqueous Solution
Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5%
Sponsored by
Universidade Federal do Para
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Sensitivity focused on measuring Clinical trials, Dentin Sensitivity, glutaraldehyde, Desensitizing agents

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Federal University of Para

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo Group

Placebo Gel + Glutaraldehyde (GPG)

Phosphoric Acid + Glutaraldehyde (GAG)

Arm Description

Placebo Gel + Placebo Solution (Distilled Water)

Placebo Gel + 5% Glutaraldehyde Aqueous Solution

37% Phosphoric Acid + Glutaraldehyde Aqueous Solution (GAG)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 16, 2019
Last Updated
April 18, 2020
Sponsor
Universidade Federal do Para
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1. Study Identification

Unique Protocol Identification Number
NCT04207450
Brief Title
Effect of Glutaraldehyde on Dentin Hypersensitivity After Non-surgical Periodontal Treatment
Official Title
Effect of Glutaraldehyde on Dentin Hypersensitivity After Non-surgical Periodontal Treatment: a Triple-blind Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
November 29, 2019 (Actual)
Study Completion Date
December 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Para

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity
Keywords
Clinical trials, Dentin Sensitivity, glutaraldehyde, Desensitizing agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Placebo Gel + Placebo Solution (Distilled Water)
Arm Title
Placebo Gel + Glutaraldehyde (GPG)
Arm Type
Experimental
Arm Description
Placebo Gel + 5% Glutaraldehyde Aqueous Solution
Arm Title
Phosphoric Acid + Glutaraldehyde (GAG)
Arm Type
Experimental
Arm Description
37% Phosphoric Acid + Glutaraldehyde Aqueous Solution (GAG)
Intervention Type
Other
Intervention Name(s)
Placebo gel
Intervention Description
Placebo gel application followed by placebo solution application (distilled water)
Intervention Type
Other
Intervention Name(s)
Placebo Gel + 5% Glutaraldehyde Aqueous Solution
Intervention Description
Placebo gel followed by 5% aqueous glutaraldehyde solution
Intervention Type
Other
Intervention Name(s)
Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5%
Intervention Description
37% phosphoric acid application followed by 5% aqueous glutaraldehyde solution
Primary Outcome Measure Information:
Title
Dentin sensitivity
Description
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.
Time Frame
Immediately after the intervention
Secondary Outcome Measure Information:
Title
Dentin hypersensitivity experience questionnaire
Description
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.
Time Frame
Immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Federal University of Para
City
Belém
State/Province
PA
ZIP/Postal Code
66075-110
Country
Brazil

12. IPD Sharing Statement

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

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