Bone Density Increased
Conditions
Keywords
Injectable platelet rich fibrin, bone dimensions, freeze dried bone allograft
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
Interventions
BIOLOGICALi-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
Sponsors
Krishnadevaraya College of Dental Sciences & Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Purposive Sampling technique will be done. All the patients who meet the eligibility criteria will be screened and then 20 patients will be randomly allotted into either of the two groups. The treatment allocation to the test and control group will be assigned by means of a sealed envelope containing a code derived from a computer-generated randomized list to receive either - 1. TEST GROUP (n =10)- FDBA and PRF(i-prf) with immediate implant placement. 2. CONTROL GROUP (n = 10) - FDBA alone with immediate implant placement.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients between 18-55 years of age. 2. Presence of non-restorable single rooted teeth (maxillary or mandibular) due to trauma, caries, root resorption, root fracture, endodontic or periodontal failure. 3. Grade I or Grade II extraction socket according to El Chaar et al 2016. 4. Good oral hygiene. 5. Good patient compliance.
Exclusion criteria
1. Systemic complications (uncontrolled diabetes and severe cardiovascular or infectious diseases). 2. Intravenous and oral bisphosphonate therapy. 3. Patients who are psychologically unable to participate. 4. Pregnant patients, patients with bone diseases and patients on chemotherapy or radiotherapy, alcohol or drug abuse. 5. Patients with hemorrhagic disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 density | At baseline, 3 months and 6 months | Bone mineral density is obtained by the CBCT (GENORAY (PAPAYA 3D premium operation software) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
India
Outcome results
None listed