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临床试验/CTRI/2024/12/078669
CTRI/2024/12/078669尚未招募不适用

Comparative evaluation of crestal bone loss levels around dental implants placed in thick and thin mucosal tissues - a clinicoradiographic study.

Dr. Bhutada Chetan Gopal1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年1月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
16
试验地点
1
主要终点
More crestal bone loss around the implants placed in thin mucosal tissue.

研究概览

简要总结

i) Rationale:

Peri-implantitis can be defined as a crestal bone loss / marginal bone loss (MBL) equal to or greater than three millimeters in the presence of clinical signs such as PPD > 6 mm and BOP.Although MBL does not always lead to peri-implantitis, there is no peri-implantitis without the prior presence of MBL. Berglundh et al. has related this to thickness of soft tissues. They reported that in thin tissues formation of gingival cuff after the second stage surgery resulted in significant bone resorption, in contrast to the thick tissue group, where no statistically reliable bone loss occurred. Hence, it seems that correlation between the thickness of gingival tissue and subsequent bone loss around implants does exist.

       ii) Novelty:

Assesment in mucosal tissue thickness classification given by Egreja et al in 2012. Marginal bone loss will be measured using CBCT in SIDEXIS 4 software with SICATSUITE version 2.0. (Dentsp  ly Sirona; York, US) immediately after implant placement and 6 months later.

 iii) Objectives:

To evaluate and compare the MBL around the implants placed in thin and thick mucosal tissue.

iv) Methods:

The mucosal tissue thickness will be assessed with transgingival probing method given by Dimitrios Kloukos et al in 2021.Radiographic assessments for MBL around the implant will be done immediately after implant placement, 6 months and 12 months later using CBCT. MBL will be measured using SIDEXIS 4 software with SICATSUITE version 2.0. (Dentsply Sirona; York, US)

        v) Expected outcome:

                Less marginal bone loss in thick mucosal tissue as compared to thin mucosal tissue.

Hypothesis:

In thin and thick mucosal tissue there might be marginal bone loss or no marginal bone loss around the implant

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
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Eighteen years of age to sixty five years of age.
  • Fully healed bone sites.
  • (at least 6 months after tooth extraction)
  • No bone augmentation procedures before and during implant placement.
  • Edentulous gap for at least 1 implant in any region of the mouth with minimum 1mm distance range from adjacent tooth/teeth.
  • No medical contraindication for implant surgery.
  • Edentulous site of implant in any region of the mouth with minimum 1mm of mucosal tissue thickness.

排除标准

  • Poor oral hygiene.
  • Symptoms or history of periodontitis or peri-implantitis treatment.
  • Smoker and alcoholic person.
  • Patients with systemic diseases.
  • Alveolar ridges with bone defects at implantation sites.
  • Attached gingiva ≤ 2 mm.

结局指标

主要结局

More crestal bone loss around the implants placed in thin mucosal tissue.

时间窗: crestal bone loss will be checked around the implants after 6 months and 12 months of implant placement with CBCT

次要结局

  • Less crestal bone loss around the implants placed in thick mucosal tissue.(crestal bone loss will be checked around the implants after 6 months and 12 months of implant placement with CBCT)

研究者

发起方
Dr. Bhutada Chetan Gopal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Bhutada Chetan Gopal

Coorg Institute Of Dental Sciences

研究点 (1)

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