跳至主要内容
临床试验/CTRI/2025/11/097333
CTRI/2025/11/097333尚未招募2/3 期

Short Term Survival Rate and Patient Satisfaction in Periodontally Compromised Patients Rehabilitated with Smooth Surface Bi-cortical implants.

Dr Megnel Leona Menezes1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年11月23日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
16
试验地点
1
主要终点
To assess clinical parameters (presence of exudate; pain levels; primary implant stability) and radiographic parameters (bone loss and radiolucency) around the implant for periodontally healthy and compromised individuals at baseline and 6 months after implant placement.

研究概览

简要总结

Rehabilitation of missing teeth with a definitive solution has become an aspiration not only to the patients but also professionals and introduction of dental implants has led to a new array of expectations and scope for immense research and development of various implant concepts.  Implant prosthesis not only replaces the missing teeth offering aesthetics but also restores function. Although implants may seem like the best treatment approach, proper case study and patient selection is crucial in determining the long-term implant success. (Herrmann et al 2005)

A retrospective study conducted among 128 single tooth conventional implant placed resulted in a survival rate of 91.60% where the main reasons for failure were inadequate or improper oral hygiene, periodontal health and occlusal stress. (Shailesh Jain et al 2024).

A recent study evaluated the marginal bone loss and bleeding on probing between machined (smooth surface) and rough surface implants suggesting that these parameters were in slight favour of machined implants (Hussein et al., 2024). Based on the conclusion in a systematic review on rough surface implants published in the year 2016, patients without history of periodontitis exhibited better implant outcome in terms of survival and success when compared to patients treated with periodontitis. (Constantine T. T. Ong, 2008). On the other hand, short dental implants placed in patients treated with generalized aggressive periodontitis did remain functionally stable. However, these implants showed higher levels of clinical attachment loss (Akram et al., 2019). Keeping this in mind placement of implants in periodontally diseased individuals poses an uncertainty in implant survival and success.

The conventional implants come with an added disadvantage with a few months of healing period leading to prolonged edentulism in patients (Ghalaut et al., 2019). Therefore, a better treatment approach for rehabilitating periodontally compromised patients with implants is much needed.

An emerging concept of bi-cortical or basal implants has gained popularity with its ease of placement and shorter surgical time when compared to conventional implants. This system is designed specifically to obtain anchorage from basal cortical bone. This cortical bone being more dense and less prone to infection provides excellent support and stability to implants. (Sikri A., et al., 2023). A prospective study where 157 basal implants placed in atrophied ridges concluded a cumulative survival of 97.5% with no signs of tenderness or periimplantitis during the observation period of 1 year (Patel et al., 2021).A 5 month evaluation done in an animal study demonstrated that bone loss progressed faster at rougher sand blasted acid etched titanium surface suggesting higher chances of peri-implantitis when compared to polished surfaces (Berglundh et al., 2007).

Aim of the study:  The aim of the study is to evaluate the short-term survival rate and patient satisfaction in periodontally compromised patients rehabilitated with smooth surface bi-cortical implants.

  Objectives of the study:

1)      To assess clinical parameters (presence of exudate; pain levels; primary implant stability) and radiographic parameters (bone loss and radiolucency) around the implant for periodontally healthy and compromised individuals at baseline and 6 months after implant placement.

2)      To evaluate and compare patient satisfaction scores of both periodontally healthy and compromised individuals at baseline and at six months after the implant restoration

3)      To compare the recorded clinical and radiographic parameters of both periodontally healthy and compromised individuals at baseline and six months after the implant restoration.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Systemically healthy patients 2) Partially edentulous maxillary and mandibular ridges.

排除标准

  • Uncontrolled diabetes mellites 2) Age less than 18 years 3) History of heavy smoking.
  • Patients having metabolic and bone diseases 5) Patients undergoing radiotherapy or chemotherapy 6) Recent history of cardiac arrest, stroke, haematological disorders.

结局指标

主要结局

To assess clinical parameters (presence of exudate; pain levels; primary implant stability) and radiographic parameters (bone loss and radiolucency) around the implant for periodontally healthy and compromised individuals at baseline and 6 months after implant placement.

时间窗: 6 months

次要结局

  • To evaluate and compare patient satisfaction scores of both periodontally healthy and compromised individuals at baseline and at six months after the implant restoration(6 months)

研究者

发起方
Dr Megnel Leona Menezes
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Megnel Leona Menezes

Ramaiah University of Applied Sciences

研究点 (1)

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