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临床试验/NCT06604013
NCT06604013已完成不适用

Class III Obesity and Periodontitis: Gingival Crevicular Fluid of Adiponectin and Resistin As Predictable Implement in Staging and Grading System and Effects of Periodontal Therapy

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年9月10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
60
试验地点
1
主要终点
adiponectin level in gingival crevicular fluid

研究概览

简要总结

The goal of this clinical trial is to evaluate the relationship between obesity and gingival crevicular fluid resistin and adiponectin in periodontitis patients as well as assess the effect of non-surgical periodontal therapy on their levels using ELISA in obese individuals. Researchers will compare different stages of periodontitis to see if degrees of inflammation and periodontal therapy related obesity

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •obese persons with Body Mass Index (BMI) more than 40 and suffering from periodontitis

排除标准

  • •Patients receiving either antibiotics or non-steroidal anti- inflammatory at least 3 months prior to samples collection.
  • •Patients subjected to previous periodontal therapy 6 months before sampling. Patients with systemic or local inflammatory conditions other than periodontal disease.
  • •Neither lactating nor pregnant.

研究组 & 干预措施

mild periodontitis (first stage, grade B)

Active Comparator

mild periodontitis (first stage, grade B) manifesting CAL ≥ 1-2 mm, in corporation with percentage of bone loss level divided by age was 0.25-1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants.

干预措施: non-surgical full-mouth periodontal therapy without using adjunct disinfectants (Procedure)

mild periodontitis (first stage, grade B)

Active Comparator

mild periodontitis (first stage, grade B) manifesting CAL ≥ 1-2 mm, in corporation with percentage of bone loss level divided by age was 0.25-1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants.

干预措施: GCF level of adiponectin and resistin (Diagnostic Test)

moderate periodontitis (second stage, grade B)

Active Comparator

moderate periodontitis (second stage, grade B) manifesting CAL ≥ 3-4mm in corporation with percentage of bone loss level divided by age was 0.25-1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants.

干预措施: non-surgical full-mouth periodontal therapy without using adjunct disinfectants (Procedure)

moderate periodontitis (second stage, grade B)

Active Comparator

moderate periodontitis (second stage, grade B) manifesting CAL ≥ 3-4mm in corporation with percentage of bone loss level divided by age was 0.25-1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants.

干预措施: GCF level of adiponectin and resistin (Diagnostic Test)

severe periodontitis (third stage, grade B)

Active Comparator

severe periodontitis (third stage, grade B) manifesting CAL ≥ 5mm , in corporation with BoP increased than (30%), percentage of bone loss level divided by age was 0.25-1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants

干预措施: non-surgical full-mouth periodontal therapy without using adjunct disinfectants (Procedure)

severe periodontitis (third stage, grade B)

Active Comparator

severe periodontitis (third stage, grade B) manifesting CAL ≥ 5mm , in corporation with BoP increased than (30%), percentage of bone loss level divided by age was 0.25-1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants

干预措施: GCF level of adiponectin and resistin (Diagnostic Test)

very severe periodontitis (forth stage, grade C)

Active Comparator

very severe periodontitis (forth stage, grade C) manifesting CAL ≥ 5mm in corporation of percentage of bone loss level divided by age more than 1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants

干预措施: non-surgical full-mouth periodontal therapy without using adjunct disinfectants (Procedure)

very severe periodontitis (forth stage, grade C)

Active Comparator

very severe periodontitis (forth stage, grade C) manifesting CAL ≥ 5mm in corporation of percentage of bone loss level divided by age more than 1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants

干预措施: GCF level of adiponectin and resistin (Diagnostic Test)

结局指标

主要结局

adiponectin level in gingival crevicular fluid

时间窗: From enrollment to the end of treatment results assessment at 12 weeks

resistin level in gingival crevicular fluid

时间窗: From enrollment to the end of treatment results assessment at 12 weeks

次要结局

  • O'Leary Plaque score(From enrollment to the end of treatment results assessment at 12 weeks)
  • bleeding on probing percentage (BoP)(From enrollment to the end of treatment results assessment at 12 weeks)
  • clinical attachment level (CAL)(From enrollment to the end of treatment results assessment at 12 weeks)
  • probing pocket depth(From enrollment to the end of treatment results assessment at 12 weeks)

研究者

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

Asem Mohammed Kamel Ali

lecturer

Al-Azhar University

研究点 (1)

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