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CTRI Number  CTRI/2017/09/009701 [Registered on: 11/09/2017] Trial Registered Retrospectively
Last Modified On: 07/09/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Surgical/Anesthesia
Dentistry 
Study Design  Single Arm Study 
Public Title of Study   The effect of replacement of infected decayed tooth with tooth implants, immediately after tooth removal. 
Scientific Title of Study   Immediate implant placement in extraction site with periapical infections - A Prospective study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Raghavendra S Medikeri 
Designation  Professor 
Affiliation  Sinhgad Dental College and Hospital 
Address  Dept of Periodontology Sinhgad Dental College and Hospital, S No 44-1, Vadgaon - Bk, Off Sinhgad Road, Pune

Pune
MAHARASHTRA
411041
India 
Phone  9766337620  
Fax    
Email  dr_raghum2000@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Raghavendra S Medikeri 
Designation  Professor 
Affiliation  Sinhgad Dental College and Hospital 
Address  Dept of Periodontology Sinhgad Dental College and Hospital S No 44-1, Vadgaon - Bk, Off Sinhgad Road, Pune

Pune
MAHARASHTRA
411041
India 
Phone  9766337620  
Fax    
Email  dr_raghum2000@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Parikshit M Wate 
Designation  Post-graduate student 
Affiliation  Sinhgad Dental College and Hospital 
Address  Dept of Periodontology, Sinhgad Dental College and Hospital, S No 44-1, Vadgaon - Bk, Off Sinhgad Road, Pune.

Pune
MAHARASHTRA
411041
India 
Phone  9766337620  
Fax    
Email  parikshitmw@gmail.com  
 
Source of Monetary or Material Support  
Sinhgad Dental College and Hospital, S No 44-1, Vadgaon - Bk, Off Sinhgad Road, Pune - 411041, Maharashtra, India.  
 
Primary Sponsor  
Name  Singad Dental College and Hospital 
Address  Department of Periodontology S No 44-1, vadgaon-Bk, Off Sinhgad Road, Pune - 411041 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Raghavendra S Medikeri  Sinhgad Dental College and Hospital, Pune  Dept of Periodontology Sinhgad Dental College and Hospital S No 44-1, Vadgaon - Bk, Off Sinhgad Road, Pune
Pune
MAHARASHTRA 
9766337620

dr_raghum2000@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sinhgad Dental College And Hospital, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  systemically healthy participants in the age group of 18 years and above with the need of an atleast single immediate post-extraction implant placement with the presence of periapical infections.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Titanium dental implants, Decalified freeze dried bone allograft and Platelet-rich-fibrin.   Following extraction of periapical infected tooth, titanium dental implant is placed immedietly in maxillary and mandibular teeth. Decalified freeze dried bone allograft and Platelet-rich-fibrin are condensed between the buccalsocket wall and implant. The outcome is evaluated at 12 months post-operatively after implant final restoration. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. systemically healthy participants
in the age a groups of 18 years to 60 years.
2. tooth associated with periapical infections with or without periapical radiolucency on intra oral periapical radiograph.
3. tooth indicated for extraction due nonrestorable carious tooth, fracture, endodontic infections.
4. participants without periodontitis. 
 
ExclusionCriteria 
Details  A. Participant with
1. compromised medical conditions and/or diseases which hampers implant placement or bone healing (ex-osseointegration)
2. smokers and alcoholics
3. parafunctional habits such as bruxims
4. undergoing cortocisteroid therapy, chemotherapy and / or radiotherapy.
B. Pregnant and lactating females. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. vertical Buccal and proximal bone levels on cone bean computer tomograph (CBCT).
2. Clinical gingival esthtic scores.
3. survival of implants 
CBCT Bone level assessment:at baseline and after 12 months of implant function.
Clinical Gingival esthetic assessment: at every six months. 
 
Secondary Outcome  
Outcome  TimePoints 
complications such as swelling, abscess formation, GIT problems (ex: diarrhea)  immediately after implant placement till end of study period. 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   14/02/2015 
Date of Study Completion (India) 24/06/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Accepted for publication in journal "The Bulletin of Tokyo Dental College" 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

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 study”. 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.

 
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