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临床试验/NCT07770906
NCT07770906尚未招募不适用

Effect of Glucagon-Like Peptide-1 Receptor Agonist Use on Periodontal Health and Response to Non-Surgical Periodontal Therapy

Cukurova University0 个研究点目标入组 40 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
Probing Depth

研究概览

简要总结

This study aims to evaluate the effects of glucagon-like peptide-1 receptor agonist (GLP-1 RA) use on periodontal health and the response to non-surgical periodontal therapy in individuals with obesity and periodontitis.

Participants with obesity and periodontitis will be divided into two groups: those who have been using a GLP-1 RA for at least 3 months and those who are not using any medication for obesity. All participants will receive the same non-surgical periodontal treatment, including oral hygiene instruction, scaling, and root planing.

Periodontal clinical measurements and gingival crevicular fluid samples will be collected before treatment and at 3 and 6 months after treatment. The study will compare changes in periodontal health and inflammatory markers between the two groups to determine whether GLP-1 RA use is associated with periodontal health and the response to non-surgical periodontal therapy.

详细描述

This prospective, controlled clinical study aims to compare periodontal clinical parameters and gingival crevicular fluid inflammatory markers between individuals with obesity and periodontitis who use GLP-1 RAs and those who do not use pharmacological treatment for obesity. The study will also evaluate and compare the clinical response to non-surgical periodontal therapy between the two groups.

A total of 40 participants with obesity and periodontitis will be included and allocated to two groups. The GLP-1 RA group will consist of 20 participants who have been regularly using a GLP-1 RA (semaglutide, liraglutide, or dulaglutide) for at least 3 months because of obesity. The control group will consist of 20 participants with obesity and periodontitis who are not using any medication for obesity.

All participants will receive the same non-surgical periodontal treatment protocol. Following the baseline periodontal examination, participants will receive oral hygiene instructions, including instruction in the modified Bass toothbrushing technique. Non-surgical periodontal therapy will be completed in two sessions under local anesthesia and will include full-mouth subgingival instrumentation and scaling and root planing using ultrasonic instruments and Gracey curettes. No adjunctive antimicrobial agents will be used. Participants in the GLP-1 RA group will continue their existing systemic GLP-1 RA treatment without modification.

Periodontal clinical assessments will include probing depth, clinical attachment level, bleeding on probing, plaque index, and gingival index. Gingival crevicular fluid samples will be collected using sterile PerioPaper® strips and stored at -80°C until analysis. Body mass index, HbA1c, and fasting blood glucose will also be evaluated using the measurements and laboratory results specified in the study protocol.

Clinical periodontal measurements and gingival crevicular fluid sampling will be performed at baseline and repeated at 3 and 6 months following non-surgical periodontal therapy. During follow-up visits, oral hygiene instructions will be reinforced, and professional supragingival cleaning will be performed when supragingival calculus accumulation is detected.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The outcomes assessor performing the periodontal clinical measurements will be blinded to the participants' GLP-1 receptor agonist use and group assignment.

入排标准

性别
All
接受健康志愿者

入选标准

  • Age between 18 and 65 years
  • Body mass index (BMI) ≥25 kg/m²
  • Presence of at least 20 functional teeth
  • Diagnosis of periodontitis
  • For the GLP-1 receptor agonist group: regular use of a GLP-1 receptor agonist for at least 3 months

排除标准

  • Age between 18 and 65 years
  • Body mass index (BMI) ≥25 kg/m²
  • Presence of at least 20 functional teeth
  • Diagnosis of periodontitis
  • For the GLP-1 receptor agonist group: regular use of a GLP-1 receptor agonist for at least 3 months

结局指标

主要结局

Probing Depth

时间窗: Baseline, 3 months- 6 months

次要结局

  • Gingival Index(Baseline, 3months- 6 months)

研究者

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

BAHAR ALKAYA

ASSOCIATE PROFESSOR

Cukurova University

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