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Enrolling by Invitation

NCT Number: NCT06522321

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

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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Key information

Conditions

Bone Density Increased Bone Diseases Bone Diseases, Developmental Musculoskeletal Diseases Osteochondrodysplasias Osteosclerosis

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dr. Prabhuji MLV

Bengaluru, Karnataka, 562157, India

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Other names: platelet rich fibrin and freeze dried bone

Primary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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

  5. 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

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 26, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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