Clinical trial NCT06522321: Radiographic Assessment of Bone Dimension Around Immediate Implants With FDBA and I-PRF vs FDBA Alone
Official title: Radiographic Assessment of Bone Dimension Around Immediate Implants With FDBA and I-PRF vs FDBA Alone- A Randomized Clinical Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Bone Density Increased
Keywords: Injectable platelet rich fibrin
bone dimensions
freeze dried bone allograft
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Bone fill
timeFrame: At baseline, 3 months and 6 months
measure: Bone dimensions
timeFrame: At baseline, 3 months and 6 months
measure: Bone density
timeFrame: At baseline, 3 months and 6 months
measure: Marginal bone level
timeFrame: At baseline, 3 months and 6 months
measure: Early wound healing index
timeFrame: At baseline, 3 months and 6 months
Secondary outcomes:
measure: GINGIVAL INDEX
timeFrame: 3 months and 6 months
measure: GINIVAL BLEEDING INDEX
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Bengaluru
country: India
facility: Dr. Prabhuji MLV
state: Karnataka
Study officials:
affiliation: PROFESSOR AND HOD
name: Dr Prabhuji MLV, MDS
role: STUDY_CHAIR
References: