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Completed

NCT Number: NCT05593198

Guided Bone Regeneration Versus Bone Block Grafting

The purpose of this study is to analyze the volumetric gain and stability of the newly formed bone tissue comparing guided bone regeneration with block graft.

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Key information

Conditions

Atrophy; Bone Atrophy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Gemelli

Rome, Italy

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients in need of an implant-supported rehabilitation
  • Patients requiring bone regeneration
  • Healthy patients
  • Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤ 15%
  • Sufficient mesiodistal and interocclusal space
  • At least 6 months of follow-up

Exclusion criteria

  • An American Society of Anesthesiologists physical status classification ≥ III
  • General contraindications for surgical treatment or implant placement
  • Untreated periodontitis
  • Smoking
  • Excessive alcohol consumption
  • Any drug or medication known to affect oral status and bone turnover or contraindicate surgical treatment
  • No residual keratinized tissue at the experimental area
  • Unwillingness to return for follow-up examinations

Treatment and study plan

Khoury technique

Procedure

the bone block will be used following the principles of the Khoury technique to augment the bone volume.

Guided bone regeneration

Procedure

the membrane and the bone granules will be used to perform the guided bone regeneration technique.

Primary outcomes

  1. Bone volume

    Time frame: 6 Months follow up

    the bone volume will be analyzed with the Cone Beam Computed Tomography scan

Secondary outcomes

  1. Periodontal parameters

    Time frame: 6 Months follow up

    the periodontal parameters will be analyzed clinically with the periodontal probe and measured in millimeters. All the periodontal parameters will be combined to describe the periodontal status of the patient.

  2. Wound healing

    Time frame: 2 weeks follow up

    the wound healing will be recorded with the Early Wound Healing Score (EHS) ranging from 0 to 10 which includes the following parameters:

    • clinical signs of re-epithelialization: 0 points, visible distance between incision margins; 3 points, incision margins in contact; 6 points, merged incision margins.
    • clinical signs of haemostasis: 0 points, bleeding at the incision margins; 1 point, presence of fibrin at the incision margins; 2 points, absence of fibrin on the incision margins.
    • clinical signs of inflammation: 0 points, redness involving >50% of the incision length and/or pronounced swelling; 1 point, redness involving <50% of the incision length; 2 points, absence of redness along the incision length.

  3. Histological analysis

    Time frame: 6 Months follow up

    The histological analysis will be performed harvesting a sample during the implant placement. Bone biopsies including both native and regenerated bone will be subjected to digital scanning to analyze the characteristics of newly formed bone, the remaining grafted material, integration of grafted material with newly formed bone, soft tissue, and local inflammation. Histomorphometric analyses will be performed to measure the following parameters: bone tissue area , graft material area , soft tissue area. Bone tissue area , graft material area , soft tissue area will be expressed relative to the total area.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Randomized Controlled Clinical Trial Comparing the Clinical Measures and the Radiographical Volumetric Outcomes Assessed by Cone Beam Computed Tomography of Guided Bone Regeneration Versus Bone Block Grafting

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2022
Registry last updated
Aug 29, 2023

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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