Radiographic Assessment of Bone Dimension Around Immediate Implants With FDBA and I-PRF vs FDBA Alone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-15

Study Completion Date

2024-10-25

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Bone Density Increased

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Radiographic Assessment of Bone Dimension Around Immediate with FDBA and i-PRF vs 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.

Group Type EXPERIMENTAL

i-PRF and FDBA

Intervention Type BIOLOGICAL

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

Radiographic Assessment of Bone Dimensions Around Immediate Implants With FDBA and I-PRF vs 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.

Group Type EXPERIMENTAL

i-PRF and FDBA

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type BIOLOGICAL

Other Intervention Names

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platelet rich fibrin and freeze dried bone

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes