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临床试验/CTRI/2024/09/074283
CTRI/2024/09/074283尚未招募3 期

Investigating the Impact of tailored healing abutment and abutment variations on peri-implant soft tissue contour in immediate implant placement with delayed loading: An In vivo study

Priyanka Arora1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年10月29日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
24
试验地点
1
主要终点
We will come to know which type of healing abutment gives best emergence profile .

研究概览

简要总结

The peri-implant soft tissue attachment  is not only important for the aesthetics but also for the success of the implant . The aim of the study is to investigate the impact of tailored healing abutment and abutment variations on peri-implant soft tissue contour in immediate implant placement with delayed loading . The study is designed to fulfill 4 objectives-

  1. To evaluate the effect of stock gingival former and stock abutment on the peri-implant soft tissue contour in immediate implant with delayed loading .

2.To evaluate the effect of stock gingival former  and customized abutment on peri implant  soft tissue contour in immediate implant with delayed loading .

3.To evaluate the effect of customized gingival former and customised abutment on peri implant soft tissue contouring immediate implant with delayed loading .

  1. To compare the soft contour around the implant pre and post use of varied customized healing abutments and final prosthesis.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Good oral hygiene.
  • Patient in the age group of 18-55 years.
  • ⁠Patients requiring single tooth replacement with immediate implant placement.
  • ⁠Mesio-distal width of 8 mm or less.
  • ⁠Presence of adjacent teeth and antagonist teeth in alignment with absence of tilting / supra-eruption.

排除标准

  • According to ASA Classification Class 4 patients: ⁠Heart disease with marked signs of cardiac insufficiency.
  • ⁠Recent myocardial infarction of less than 6 months duration.
  • ⁠Unstable angina.
  • ⁠Patients with advanced degrees of pulmonary, renal or endocrine insufficiency.
  • ⁠Severe cardiac valvular dysfunction ⁠Sepsis ⁠Disseminated intravascular coagulation According to ASA Classification class 3 patients: ⁠Uncontrolled diabetes with complications to vascular or other organs i.e. retinopathy, neuropathy etc.
  • Active hepatitis ⁠Implanted pacemaker ⁠Immunocompromised patients   ⁠Blood dyscrasias   ⁠Occlusal anomalies ⁠Deep Bite ⁠Cross Bite Para-functional habits Bruxism  ⁠⁠Radiation therapy in orofacial region   ⁠Heavy smokers (more than 10 cigarettes per day)  ⁠⁠Alcohol abusers   ⁠Recent history of any acute illness  ⁠⁠Patients having unrealistic expectations and psychological problems.
  • ⁠⁠Local factors: ⁠Teeth associated with large periapical lesions (granuloma & cyst) ⁠⁠Periodontally compromised teeth with one or more bony wall defects ⁠⁠Presence of dehiscence or fenestrations of residual bony walls ⁠⁠Insufficient inter-arch space ⁠⁠Intraoral draining sinus in relation to the proposed implant site ⁠Perforation and/or loss of labial bony plate during extraction ⁠Unfavourable implant axis orientation ⁠⁠Patients with TMJ disorders ⁠⁠Thin gingival tissue biotypes.

结局指标

主要结局

We will come to know which type of healing abutment gives best emergence profile .

时间窗: First scan will be done at Baseline -at o month during implant placement. | Second scan will be done at 3 months (during loading) & | Third Scan will be done 3 months post loading.

次要结局

  • We will look for bleeding index & plaque index.(First time point is at o month during implant placement)

研究者

发起方
Priyanka Arora
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Priyanka Arora

SGT University

研究点 (1)

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