Radiographic Assessment of Bone Dimension Around Immediate Implants With FDBA and I-PRF vs FDBA Alone
- Conditions
- Bone Density Increased
- Interventions
- Biological: i-PRF and FDBA
- Registration Number
- NCT06522321
- Lead Sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- 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
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 20
- 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 2016.
- Good oral hygiene.
- Good patient compliance.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Radiographic Assessment of Bone Dimensions Around Immediate Implants With FDBA and I-PRF vs FDBA i-PRF and FDBA CONTROL GROUP: FDBA alone with immediate implant placement. Local anesthesia is given. Atraumatic extraction is done.Osteotomy is done at the selected site after radiographic assessment. Immediate implant is placement along with FDBA alone. Suture is placed at the surgical site. Radiographic Assessment of Bone Dimension Around Immediate with FDBA and i-PRF vs FDBA i-PRF and FDBA TEST GROUP: FDBA and I-PRF with immediate implant placement. Local anesthesia is given. Atraumatic extraction is done. I-PRF is prepared by centrifugation procedure. Osteotomy is done at the selected site after radiographic assessment. Immediate implant is placement along with I-PRF and FDBA. Suture is placed at the surgical site.
- Primary Outcome Measures
Name Time Method Bone fill 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 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 At baseline, 3 months and 6 months Bone mineral density is obtained by the CBCT (GENORAY (PAPAYA 3D premium operation software)
Marginal bone level 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 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 Outcome Measures
Name Time Method GINGIVAL INDEX 3 months and 6 months The severity of gingivitis is scored on the mesiofacial and distofacial papillae, facial and lingual margin of selected teeth.
A blunt instrument is used to assess the bleeding potential of tissues
The index relies entirely on visual criteria of gingivitis and eliminates the use of probing or pressure to establish the presence or absence of bleeding.GINIVAL BLEEDING INDEX 3 months and 6 months The gingival bleeding index of Ainamo J and Bay I was developed as an easy and suitable way for assessing a patient's progress in Plaque control. The presence or absence of gingival bleeding is determined by gentle probing of the gingival crevice with a periodontal probe. The appearance of bleeding within 10 seconds indicates a positive score, which is expressed as percentage of the total number of gingival margin examined.
Trial Locations
- Locations (1)
Dr. Prabhuji MLV
đŸ‡®đŸ‡³Bengaluru, Karnataka, India