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临床试验/CTRI/2025/02/080523
CTRI/2025/02/080523尚未招募4 期

Comparative evaluation of clinical and radiographic changes in periodontal tissues of patients with subgingival carious lesions restored with resin modified glass ionomer cement versus resin composite with simultaneous open flap debridement : A randomized clinical trial

Dr Kruti Nayak1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月17日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Probing pocket depth

研究概览

简要总结

Patient referred to the department of periodontia, will be screened for subgingival carious lesions. After fulfilling the inclusion and exclusion criteria patient will be informed. After informing the patient about the study and completing the formalities in the consent form, the patients will be enrolled and data collection in the proforma will be done. After endodontic treatment if needed and phase 1 therapy patients will be recalled and evaluated. Baseline data of clinical parameters which are Plaque index (PI) Gingival index (GI) Probing pocket depth (PD) Clinical attachment level (CAL) and radiographic parameters which is bone height will be recorded. Patient preparation will be done and local anesthesia will be given. Flap surgery will be performed for assisting the restorative procedure since it could aid in establishing a proper access to the operative site, debriding the area and rendered attachment at a desirable area favoring less recession post-operatively. Group A will be restored with resin modified glass ionomer cement group. Group B will be restored with resin composite. 4-0 suture will be passed through buccal and lingual papilla and suture will be placed. Post-operative instructions will be given. Patient will be prescribed with antibiotics and analgesics for 5 days. Sutures will be removed one week post operatively. Follow up after 3 months and 6 months will be taken and clinical and radiographic changes will be recorded.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

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

入选标准

  • No systemic conditions that would contraindicate routine periodontal procedures The sites having radiographic evidence of subgingival caries and probing depth of equal to or greater than 4 mm.

排除标准

  • Patients with deleterious oral habits such as smoking, tobacco chewing.
  • Pregnant and lactating mothers.
  • Patients who were on anti inflammatory drugs consumption within the past 3 months.

结局指标

主要结局

Probing pocket depth

时间窗: Baseline 3 months 6 months

次要结局

  • Plaque index (PI)(Gingival index (GI))

研究者

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

Dr Kruti Nayak

Government Dental College and Hospital Jamnagar

研究点 (1)

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