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NCT Number: NCT04207450

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Para

Belém, Pará, 66075-110, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo gel

Other

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

Placebo Gel + 5% Glutaraldehyde Aqueous Solution

Other

Placebo gel followed by 5% aqueous glutaraldehyde solution

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

Other

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

Primary outcomes

  1. Dentin sensitivity

    Time frame: Immediately after the intervention

    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 outcomes

  1. Dentin hypersensitivity experience questionnaire

    Time frame: Immediately after the intervention

    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.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Para

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2019
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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