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临床试验/CTRI/2017/09/009701
CTRI/2017/09/009701已完成2/3 期

Immediate implant placement in extraction site with periapical infections - A Prospective study

Singad Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年2月14日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
2. Clinical gingival esthtic scores.

研究概览

简要总结

Background:

The immediate placement of dental implant into the extraction socket avoids the undesirable resorption of alveolar bone volume and thus renders favourable implant placement. This technique offers advantages such as minimizes the number of surgical procedures by combining extraction, implant placement and bone grafting in a single session. Often immediate implants are deferred or avoided at a site (periodontal or endodontic) where infection is present because of the fear of failure possibly due to bacterial contamination of implant surface at the initial stages. Recent literature have concluded that similar success rates have been reported for immediate implants placed in infected sites compared to non-infected sites provided control of infections with thorough alveolar curettage and irrigation and use of antibiotics.1-5

The use of platelet rich in growth factors are considered as safe, effective and predictable treatment option for the rehabilitation with success rate up to 98.4% after one year.6 Histologically, it is observed that numerous newly proliferative vascular endothelial cells and regenerative molecules are present at the site of inflammation. Autologous platelet rich in growth factors (PRGFs) has been proposed as an aid to enhance regeneration of osseous tissues in oral surgery.7 Several in vitro studies, animal experiments, and clinical studies have shown that platelet-derived growth factors can effectively trigger stimulation of osseous and soft tissue regeneration, as well as reduce inflammation, pain, and unwanted side effects.1

The elimination of apical infections through mechanical debridement with systemic medication and incorporation of growth factors in the healing socket with immediate implant placement is actually beneficial in clinical conditions is still unknown. Till date there are no studies regarding the adjunctive role of second generation growth factors i.e. PRF to decalcified freeze dried allograft in immediate implant placement in chronic periapical infection sites. Hence, this study was aimed to assess the survival of immediate implant placement in an extraction site exhibiting chronic periapical lesions and PRF as an adjunct to decalcified freeze dried allograft.

Aims:

To assess the outcome of immeditely placed implants at the tooth extraction sites with the presence of periapical infection..

Objectives:

  1. To assess and compare the bone levels on proximal and facial aspect after immedite implant placement in periapical infected sites and 12 months after final restoration with platelet-rich-fibrin and decalcified freezed dried bone allograft.
  2. To assess and compare the interdental palliae levels after immedite implant placement in periapical infected sites, 6- and 12-months after final restoration with platelet-rich-fibrin and decalcified freezed dried bone allograft.
  3. To assess survival of immediate implant placement in fresh extraction with periapical infection assoicated with platelet-rich-fibrin and decalcified freezed dried bone allograft.

References:

  1. Lindeboom JA, Tjiook Y, Kroon FH. Immediate placement of implants in periapical infected sites: a prospective randomized study in 50 patients. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006; 101: 705-710.
  2. Siegenthaler DW, Jung RE, Holderegger C, Roos M, Hammerle CHF. Replacement of teeth exhibiting periapical pathology by immediate implants. A prospective, controlled clinical trial. Clin Oral Impl Res 2007; 18: 727-737.
  3. Del Fabbro M. “Immediate implant placement into fresh extraction    sites with chronic periapical pathologic features combined with plasma rich in growth factors: preliminary results of single-cohort studyâ€. Journal of Oral and Maxillofacial Surgery. 2009 Nov;67(11):2476-84.
  4. Crespi R, Cappare P, Gherlone E. Fresh-socket implants in periapical infected sites in humans. Journal Periodontol 2010; Mar;81(3):378-83.
  5. Marconcini S, Barone A, Gelpi F, Briguglio F, Covani U. Immediate implant placement in infected site. J Periodontol 2013; 86:196-202.
  6. Truninger TC, Philipp AOH, Siegenthaler DW, Roos M, Hammerle CHF, Jung RE. A prospective, controlled clinical trial evaluating the clinical and radiological outcome after 3 years of immediately placed implants in sockets exhibiting periapical pathology. Clin. Oral Impl. Res. 2010:20:1-8.
  7. Antitua E, Gorka O, Isabel A. Use of platelet rich in growth factors (PRGFs) to accelerate bone and soft tissue regeneration in postextraction sites. Implant dialogue article. Pg 3-14.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • systemically healthy participants in the age a groups of 18 years to 60 years.
  • tooth associated with periapical infections with or without periapical radiolucency on intra oral periapical radiograph.
  • tooth indicated for extraction due nonrestorable carious tooth, fracture, endodontic infections.
  • participants without periodontitis.

排除标准

  • Participant with
  • compromised medical conditions and/or diseases which hampers implant placement or bone healing (ex-osseointegration)
  • smokers and alcoholics
  • parafunctional habits such as bruxims
  • undergoing cortocisteroid therapy, chemotherapy and / or radiotherapy.
  • Pregnant and lactating females.

结局指标

主要结局

2. Clinical gingival esthtic scores.

时间窗: CBCT Bone level assessment:at baseline and after 12 months of implant function. | Clinical Gingival esthetic assessment: at every six months.

1. vertical Buccal and proximal bone levels on cone bean computer tomograph (CBCT).

时间窗: CBCT Bone level assessment:at baseline and after 12 months of implant function. | Clinical Gingival esthetic assessment: at every six months.

3. survival of implants

时间窗: CBCT Bone level assessment:at baseline and after 12 months of implant function. | Clinical Gingival esthetic assessment: at every six months.

次要结局

  • complications such as swelling, abscess formation, GIT problems (ex: diarrhea)(immediately after implant placement till end of study period.)

研究者

发起方
Singad Dental College and Hospital
申办方类型
Research institution and hospital

研究点 (1)

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