| 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 |
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Type of Study
|
Biological Surgical/Anesthesia Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
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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 |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
|
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Source of Monetary or Material Support
|
| Sinhgad Dental College and Hospital,
S No 44-1, Vadgaon - Bk, Off Sinhgad Road, Pune - 411041, Maharashtra, India. |
|
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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 |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sinhgad Dental College And Hospital, Pune |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| 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., |
|
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Intervention / Comparator Agent
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| 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. |
|
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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. |
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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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. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| complications such as swelling, abscess formation, GIT problems (ex: diarrhea) |
immediately after implant placement till end of study period. |
|
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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 |
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Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
Accepted for publication in journal "The Bulletin of Tokyo Dental College" |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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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: - 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.
- 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.
- 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: - 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.
- 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.
- 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.
- Crespi R, Cappare P, Gherlone E. Fresh-socket implants in periapical infected sites in humans. Journal Periodontol 2010; Mar;81(3):378-83.
- Marconcini S, Barone A, Gelpi F, Briguglio F, Covani U. Immediate implant placement in infected site. J Periodontol 2013; 86:196-202.
- 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.
- 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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