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

July 27, 2024 updated by: Dr Prabhuji MLV, Krishnadevaraya College of Dental Sciences & Hospital

Radiographic Assessment of Bone Dimension Around Immediate Implants With FDBA and I-PRF vs FDBA Alone- A Randomized Clinical Controlled Trial

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Bengaluru, Karnataka, India, 562157
        • Dr. Prabhuji MLV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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

Other Names:
  • platelet rich fibrin and freeze dried bone
Experimental: 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.
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

Other Names:
  • platelet rich fibrin and freeze dried bone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone fill
Time Frame: 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.
At baseline, 3 months and 6 months
Bone dimensions
Time Frame: 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.
At baseline, 3 months and 6 months
Bone density
Time Frame: At baseline, 3 months and 6 months
Bone mineral density is obtained by the CBCT (GENORAY (PAPAYA 3D premium operation software)
At baseline, 3 months and 6 months
Marginal bone level
Time Frame: 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
At baseline, 3 months and 6 months
Early wound healing index
Time Frame: 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
At baseline, 3 months and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GINGIVAL INDEX
Time Frame: 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.
3 months and 6 months
GINIVAL BLEEDING INDEX
Time Frame: 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.
3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Investigators

  • Study Chair: Dr Prabhuji MLV, MDS, PROFESSOR AND HOD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2023

Primary Completion (Estimated)

August 25, 2024

Study Completion (Estimated)

October 25, 2024

Study Registration Dates

First Submitted

July 22, 2024

First Submitted That Met QC Criteria

July 22, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 27, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02_D012_147480

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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