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临床试验/CTRI/2024/03/063788
CTRI/2024/03/063788已完成Unknown

A comparative evaluation of biological marker and prosthodontic complication in splinted and nonsplinted implant supported prostheses: A split mouth study

Dr. Divya Dharshini M1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年3月20日最近更新:

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
1. Clinical evaluation of probing depth

研究概览

简要总结

This Prospective study is aimed to compare splinted and nonsplinted conventionally loaded Implants supported prostheses restored with Screw- Cement Retained Prostheses (SCRP) system.

AIMS AND OBJECTIVE:

The objective of the study will be to evaluate and compare the following parameters in splinted and nonsplinted implant supported prostheses:

1.   1. Soft tissue health around the implant.

2.    2. Marginal bone Loss

3.    3. Level of IL-1β in the Peri-implant crevicular fluid (PICF)

4.    4. To Assess Prosthodontic complications such as fractured/chipped prosthesis, crown de-cementation, and/or loosened abutment screw.

Study design:  The present study will be designed as a Split-mouth study, i.e. each patient will be treated as a Control group as well as a Test group.

INTERVENTION:

Following 3-5 months of healing,  patients will be randomly restored with Screw and Cement-Retained prostheses (SCRP) non-splinted prostheses on ipsilateral side, and splinted prostheses on contralateral side.

For consistency, same type of abutment will be used with internal hex connections.

Post restorationof splinted and nonsplinted implant supported prosthesis the parameters are evaluated at Baseline, 3rd month and 6th month follow up period.

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 70.00 Year(s)(—)
性别
All

入选标准

  • At least two missing teeth on both sides in Posterior region of jaw.
  • Adequate bone height for accommodating two implants and to be placed at same appointment.
  • Patient without any dental pathologies and medical conditions.
  • Extraction is done at least 3-4 months prior to implant placement.
  • Restored with opposing dentition/implant in occlusion.

排除标准

  • Untreated caries/ Periodontal Diseases in Residual dentition.
  • Medically compromised patients (any past records of Uncontrolled Diabetes, radiation, Chemotherapy treatment, psychological problems ), Severe bruxism cases, and any TMD cases.
  • Patients under systemic corticosteroids or Bisphosphonates therapy.
  • Pregnant / Nursing at the time of enrollment.

结局指标

主要结局

1. Clinical evaluation of probing depth

时间窗: Baseline, 3rd month , 6th month

2. Radiographical evaluation of Marginal bone loss

时间窗: Baseline, 3rd month , 6th month

3. Evaluation of levels of IL-1 Beta

时间窗: Baseline, 3rd month , 6th month

次要结局

  • Prosthodontic Complications(Baseline, 3rd month , 6th month)

研究者

发起方
Dr. Divya Dharshini M
申办方类型
Other [self funded ]
责任方
Principal Investigator
主要研究者

Divya Dharshini M

King Georges Medical University

研究点 (1)

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