A Phase 2 interventional study of i-PRF and FDBA in Bone Density Increased, sponsored by Krishnadevaraya College of Dental Sciences & Hospital. Enrolling by invitation at 1 site in India. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by Krishnadevaraya College of Dental Sciences & Hospital · Phase 2, Interventional, and Treatment
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.
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
Krishnadevaraya College of Dental Sciences & Hospital is the lead sponsor of 51 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
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.
Biological: 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.
Biological: i-PRF and FDBA
A mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with FDBA and I-PRF (experimental group) will be placed according to the standard protocol. An immediate implant with FDBA( comparative group) will be placed according to the standard protocol . The surgical wound closure will be coapted with sutures
Also known as: platelet rich fibrin and freeze dried bone
Bone fill
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.
Time frame: At baseline, 3 months and 6 months
Bone dimensions
The sites will be assessed vertically and horizontally by CBCT images taken at baseline and 6 months after the implant placement.
Time frame: At baseline, 3 months and 6 months
Bone density
Bone mineral density is obtained by the CBCT (GENORAY (PAPAYA 3D premium operation software)
Time frame: At baseline, 3 months and 6 months
Marginal bone level
distance between reference point(the implant shoulder) and the first marginal bone-to-implant contact level using standard digital radiographs
Time frame: At baseline, 3 months and 6 months
Early wound healing index
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
Time frame: At baseline, 3 months and 6 months
GINGIVAL INDEX
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.
Time frame: 3 months and 6 months
GINIVAL BLEEDING INDEX
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.
Time frame: 3 months and 6 months
Plan to share: No
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Osteosclerosis
Krishnadevaraya College of Dental Sciences & Hospital