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

NCT06522321 | Enrolling By Invitation Phase 2

• 1 other identifier: 02_D012_147480
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Density Increased

Keywords

Injectable platelet rich fibrin; bone dimensions; freeze dried bone allograft

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  At baseline, 3 months and 6 months

• Bone density

  Bone mineral density is obtained by the CBCT (GENORAY (PAPAYA 3D premium operation software)

  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

  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

  At baseline, 3 months and 6 months

Secondary Outcomes (2)

• GINGIVAL INDEX

  3 months and 6 months

• GINIVAL BLEEDING INDEX

  3 months and 6 months

Study Arms (2)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

i-PRF and FDBA 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

Also known as: platelet rich fibrin and freeze dried bone

Radiographic Assessment of Bone Dimension Around Immediate with FDBA and i-PRF vs FDBA; Radiographic Assessment of Bone Dimensions Around Immediate Implants With FDBA and I-PRF vs FDBA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Study Sites (1)

Dr. Prabhuji MLV

Bengaluru, Karnataka, 562157, India

Location

MeSH Terms

Conditions

Osteosclerosis

Interventions

proliferation regulatory factors, human urine

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Dr Prabhuji MLV, MDS

  PROFESSOR AND HOD

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HOD OF PERIODONTOLOGY

Model Details: 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.

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: July 15, 2023
• Primary Completion: August 25, 2024
• Study Completion: October 25, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)