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临床试验/CTRI/2025/03/082987
CTRI/2025/03/082987尚未招募3 期

Comparative assessment of bacterial accumulation on prolene 3-0 suture and silk 3-0 suture following flap surgery in chronic Periodontitis Patients A Randomized Clinical Trial

DrIyyappanR1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
54
试验地点
1
主要终点
1) To evaluate the bacterial accumulation on prolene 3-0 suture and silk 3-0 suture following flap surgery in chronic periodontitis patients

研究概览

简要总结

Periodontitis is a multifactorial disease resulting in inflammation and

destruction of the connective tissue attachment of the teeth.

Periodontal pocket formation is usually a sequalae of the disease.

The periodontal flap is one of the most frequently employed

procedures, particularly in deep periodontal pockets. Flap surgery for

periodontal re-attachment, demands close post-operative adaptation

of gingival connective tissue on to the tooth surface .1

This study is an institutional based Interventional Prospective

Randomized Clinical Trial

The patients will be selected as per the inclusion and

exclusion criteria, and randomly allotted by a computerized

automated randomization method into 2 groups, Group A and

Group B, and treated as follow.

Group A: Open flap debridement in which flaps will be

approximated by silk 3-0 suture.

Group B - Open flap debridement in which flaps will be

approximated by prolene 3-0 suture.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients in the age group between 20-60 yrs.
  • Patients diagnosed with Chronic Periodontitis.
  • Patients who are non smokers or do not consume tobacco in any other form.
  • Patients in good systemic health with no contraindication to periodontal surgery.
  • Patients having pocket depths greater than5mm.
  • Involved teeth to be vital and asymptomatic.

排除标准

  • Patients suffering from any systemic diseases or with a compromised immune system.
  • Patients who has received any type of periodontal surgery for the past 6 months.
  • Patients taking immunosuppressant drugs like corticosteroids.
  • Patients with a known history of allergy to Doxycycline or Chlorhexidine or any other medicine used in the study.
  • Patients showing unacceptable oral hygiene compliance during / after Phase I periodontal therapy.
  • Patients taking any drug known to cause gingival enlargement.
  • Pregnant and/or lactating mothers.
  • Patients with any active oral or periodontal lesions.

结局指标

主要结局

1) To evaluate the bacterial accumulation on prolene 3-0 suture and silk 3-0 suture following flap surgery in chronic periodontitis patients

时间窗: At baseline, 2 weeks, 4 weeks

2) To compare the bacterial accumulation on prolene 3-0 suture and silk 3-0 suture following flap surgery in chronic periodontitis patients

时间窗: At baseline, 2 weeks, 4 weeks

次要结局

  • Plaque index, Gingival index, Probing pocket depth(Baseline, 3 months, 6 months)

研究者

发起方
DrIyyappanR
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR.IYYAPPAN R

Nair Hospital Dental College Mumbai

研究点 (1)

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