NCT05593198
Completed
Not Applicable
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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country44 target enrollmentNovember 1, 2022
ConditionsAtrophy; Bone
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrophy; Bone
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Bone volume
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
Bone volume
Time Frame: 6 Months follow up
the bone volume will be analyzed with the Cone Beam Computed Tomography scan
Secondary Outcomes
- Periodontal parameters(6 Months follow up)
- Histological analysis(6 Months follow up)
- Wound healing(2 weeks follow up)
Study Sites (1)
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