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临床试验/CTRI/2025/11/097248
CTRI/2025/11/097248尚未招募不适用

Evaluation of soft tissue augmentation and crestal bone loss simultaneous to Implant placement in different mucosal biotypes with or without connective tissue graft: Clinico- radiographic study

Dr Laxmi Mallikarjun Boragi1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年12月1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

研究概览

简要总结

i) **Rationale:**Dental implants are reliable solution for tooth loss, but soft tissue regression, alveolar bone resorption can impact outcome and aesthetics. Research by Berglundh et al. concludes thinner tissues lead to more significant bone loss, while thicker tissues help preserve bone levels.To assure greatest therapeutic benefit, both soft and hard tissue augmentation techniques are used,with autogenous connective tissue grafts (CTG) being the gold standard for soft tissue enhancement due to their biocompatibility and regenerative potential.This study aims to evaluate the effect of CTG on soft tissue augmentation and crestal bone levels[CBL] in different mucosal biotypes during implant placement.

**ii) Novelty:**Implant placement along with CTG in thin mucosal biotype by Egreja et al 2012and without in thick biotype and soft tissue augmentation will be assessed. CBL will be assessed in both mucosal biotypes using CBCT - CS Imaging [care stream imaging] version 8.0.

ii) Objectives**:**

·   Soft tissue augmentation is assessed in thin biotype with CTG and without in thick biotype simultaneous to implant placement at baseline, 3, 6, and 9 months.

·   To evaluate and compare the CBL around implants placed in different mucosal biotype at baseline, immediately after placement and 9 months.

iv) Methods:

Mucosal thickness is assessed via transgingival probing by Dimitrios Kloukas et al 2021using endodontic spreader and endodontic gauge.  Soft tissue augmentation is evaluated with CTG in thin and without in thick. CBL is assessed via CBCT.

V) Expected outcome:

Minimal soft tissue regression and CBL in thin tissue with CTG as compared to thick tissue alone.

Hypothesis: Placement of a connective tissue graft during implant placement in thin mucosal biotype enhances peri-implant soft tissue thickness and reduces crestal bone loss compared to sites without grafting in thick mucosal biotype.

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
22.00 Day(s) 至 60.00 Day(s)(—)
性别
All

入选标准

  • Subjects who are willing to participate in the study and given written consent for the same.
  • Subjects in age group of 22 years to 60 years, both males and females who are systemically healthy.
  • Completely healed edentulous ridges (at least 3 months after tooth extraction), periodontally sound neighbouring teeth, having no contraindications to the implantation procedure will be motivated for implant treatment.
  • No bone augmentation procedures before and during implant placement.
  • No medical contraindication for implant surgery.
  • Patients with no systemic diseases and bone metabolic disorders are included.
  • Patients with adequate interarch space.
  • Good oral hygiene.

排除标准

  • Patients with systemic diseases that could influence periodontal conditions or history of periodontitis or peri-implantitis treatment.
  • Poor oral hygiene, smoking, subjects consuming tobacco in any form, alcoholic person, use of drugs affecting bone remodeling.
  • Presence of systemic disease affecting bone loss, uncontrolled diabetes.
  • Immediate implant loading and fresh socket implant.
  • Alveolar ridges with bone defects at implantation sites.
  • General contraindications for implant surgery (e.g., Psychiatric problems, pregnant or lactating females) or presence of life-threatening conditions like cardiac complications.
  • Patient with the history of radiotherapy and chemotherapy.
  • Supraerupted opposing tooth.

研究者

发起方
Dr Laxmi Mallikarjun Boragi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Laxmi Mallikarjun Boragi

P.M. Nadagouda Memorial Dental College and Hospital

研究点 (1)

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