Study Results
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Basic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2018-01-24
2019-12-09
Brief Summary
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Detailed Description
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Cases will be selected according to the inclusion criteria after obtaining informed consent from the parents. Patients will be diagnosed based on clinical signs \& symptoms, intraoral \& radiographic findings. A routine medical history followed by blood investigations will be part of the surgical protocol.
After meeting the above criteria the patients will be randomly assigned to either PRF group (Group-A) or Mineralised FDBA group (Group-B) After successful administration of Local Anaesthesia the surgical procedure will be carried out that will include reflection of a full thickness mucoperiosteal flap by sulcular incision and two relieving vertical incisions. Debridement of tissues at the defect site will be done followed by irrigation with sterile saline solution.
In Group-A patients :- 10ml of venous blood will be drawn from the patients by using a 18 gauge needle after selecting a suitable site for venipuncture. Blood will be collected in tubes without anticoagulant and immediately centrifuged at 3,000 rpm for 10min which will result in a fibrin clot containing the platelets located in the middle of the tube, between a layer of red blood cells at the bottom and acellular plasma at the top. This clot will be removed from the tube and the attached red blood cells will be scraped off and discarded.
PRF will be placed into the defect site and wound closure will be performed using appropriate sutures.
In Group-B patients :- Graft material i.e., Mineralised freeze-dried bone allograft (obtained from Tissue Bank, Tata Memorial Hospital) will be mixed with sterile saline solution, followed by careful placement into the defect site.
The flap will be then re-placed to its original position and sutured with appropriate sutures to ensure complete soft tissue coverage of the graft site.
Sutures will be removed after 7 days post-operatively. The cases will be followed up with clinical and radiographic examination and will be recalled at intervals of 3,6, and 9 months to assess the periapical area.
\*Any changes in the plan of study will be made as in when necessary following which suitable statistical analysis will be used to analyse the result.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Platelet Rich Fibrin group(PRF)
Following apicoectomy PRF gel was prepared and placed in the osseous defect followed by placement of PRF membrane
Platelet Rich Fibrin
regeneration, restoration or reconstitution of the lost periapical tissues of the tooth by using regenerative therapies that utilize growth factors and barrier membranes.
Freezed Dried Bone Allograft group(FDBA)
Following apicoectomy FDBA graft were prepared and placed in the osseous defect followed by placement of PRF membrane
FDBA
regeneration, restoration or reconstitution of the lost periapical tissues of the tooth by using regenerative therapies that utilize growth factors and barrier membranes.
Interventions
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Platelet Rich Fibrin
regeneration, restoration or reconstitution of the lost periapical tissues of the tooth by using regenerative therapies that utilize growth factors and barrier membranes.
FDBA
regeneration, restoration or reconstitution of the lost periapical tissues of the tooth by using regenerative therapies that utilize growth factors and barrier membranes.
Eligibility Criteria
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Inclusion Criteria
* Teeth with bony defect confined to periapical area.
* Adult individuals presenting a tooth with persisting periapical radiolucency.
* Adult individuals presenting a tooth with persistent fistula.
* Adult individuals presenting a tooth with persisting symptoms after orthograde re-treatment.
Exclusion Criteria
19 Years
40 Years
ALL
Yes
Sponsors
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Saraswati Dental College
OTHER
Responsible Party
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Madhur Garg
Principal Investigator
Principal Investigators
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Madhur Garg
Role: PRINCIPAL_INVESTIGATOR
Saraswati Dental College
Locations
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Madhur Garg
Lucknow, Uttar Pradesh, India
Countries
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Other Identifiers
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SDC/IRDC/2017/MDS-P/05
Identifier Type: -
Identifier Source: org_study_id
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