Radiographic Assessment of Bone Dimension Around Immediate Implants With FDBA and I-PRF vs FDBA Alone- A Randomized Clinical Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Bone Density Increased
- Sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Bone fill
- Status
- Enrolling By Invitation
- Last Updated
- last year
Overview
Brief Summary
The present study is a human, prospective, parallel, randomised controlled clinical trial conducted for radiographic assessment of bone dimension around immediate implants with FDBA and I-PRF vs FDBA Alone The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
Detailed Description
Twenty healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients. All the patients were treated with immediate implants in endodontically and periodontically compromised sites. FDBA graft along with I-PRF is combined to form a sticky bone, this stable element is placed around the implants where bone is compromised. The clinical and radiographic parameters were recorded at baseline, three months and six months postoperatively
Investigators
Dr Prabhuji MLV
HOD OF PERIODONTOLOGY
Krishnadevaraya College of Dental Sciences & Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients between 18-55 years of age.
- •Presence of non-restorable single rooted teeth (maxillary or mandibular) due to trauma, caries, root resorption, root fracture, endodontic or periodontal failure.
- •Grade I or Grade II extraction socket according to El Chaar et al
- •Good oral hygiene.
- •Good patient compliance.
Exclusion Criteria
- •Systemic complications (uncontrolled diabetes and severe cardiovascular or infectious diseases).
- •Intravenous and oral bisphosphonate therapy.
- •Patients who are psychologically unable to participate.
- •Pregnant patients, patients with bone diseases and patients on chemotherapy or radiotherapy, alcohol or drug abuse.
- •Patients with hemorrhagic disorders.
Outcomes
Primary Outcomes
Bone fill
Time Frame: At baseline, 3 months and 6 months
Standard digital radiographs were taken at baseline, 3 months and 6 months by paralleling/long-cone technique. Radiographic images at all the time intervals were taken by using a metallic counting grid (IOPA film grid® , BlueDent, Chennai, India). The bone-fill was measured in square millimeters by point-counting the number of squares over newly developing radiopacities at different follow up periods. Squares that were half filled or unclear were not counted.
Bone dimensions
Time Frame: At baseline, 3 months and 6 months
The sites will be assessed vertically and horizontally by CBCT images taken at baseline and 6 months after the implant placement.
Bone density
Time Frame: At baseline, 3 months and 6 months
Bone mineral density is obtained by the CBCT (GENORAY (PAPAYA 3D premium operation software)
Marginal bone level
Time Frame: At baseline, 3 months and 6 months
distance between reference point(the implant shoulder) and the first marginal bone-to-implant contact level using standard digital radiographs
Early wound healing index
Time Frame: At baseline, 3 months and 6 months
SCORE 1: COMPLETE FLAP CLOSURE NO FIBRIN LINE IN THE INTERPROXIMAL AREA SCORE 2: COMPLETE FLAP CLOSURE FINE FIBRIN LINE IN THEINTERPROXIMAL AREA SCORE 3: COMPLETE FLAP CLOSURE FIBRIN CLOT IN THE INTERPROXIMAL AREA SCORE 4:INCOMPLETE FLAP CLOSURE PARTIAL NECROSIS OF THE INTERPROXIMAL AREA SCORE 5: INCOMPLETE FLAP CLOSURE COMPLETE NECROSIS OF THE INTERPROXIMAL AREA. SCORE 1: COMPLETE FLAP CLOSURE NO FIBRIN LINE IN THE INTERPROXIMAL AREA SCORE 2: COMPLETE FLAP CLOSURE FINE FIBRIN LINE IN THEINTERPROXIMAL AREA SCORE 3: COMPLETE FLAP CLOSURE FIBRIN CLOT IN THE INTERPROXIMAL AREA SCORE 4:INCOMPLETE FLAP CLOSURE PARTIAL NECROSIS OF THE INTERPROXIMAL AREA SCORE 5: INCOMPLETE FLAP CLOSURE COMPLETE NECROSIS OF THE INTERPROXIMAL AREA. Wachet et al wound healing index will be used for obtaining the healing index
Secondary Outcomes
- GINGIVAL INDEX(3 months and 6 months)
- GINIVAL BLEEDING INDEX(3 months and 6 months)