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临床试验/NCT04207450
NCT04207450已完成不适用

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

Universidade Federal do Para1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Dentin sensitivity

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

Placebo Group

Placebo Comparator

Placebo Gel + Placebo Solution (Distilled Water)

干预措施: Placebo gel (Other)

Placebo Gel + Glutaraldehyde (GPG)

Experimental

Placebo Gel + 5% Glutaraldehyde Aqueous Solution

干预措施: Placebo Gel + 5% Glutaraldehyde Aqueous Solution (Other)

Phosphoric Acid + Glutaraldehyde (GAG)

Experimental

37% Phosphoric Acid + Glutaraldehyde Aqueous Solution (GAG)

干预措施: Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5% (Other)

结局指标

主要结局

Dentin sensitivity

时间窗: 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.

次要结局

  • Dentin hypersensitivity experience questionnaire(Immediately after the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cecy Martins Silva

Clinical Professor

Universidade Federal do Para

研究点 (1)

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