Skip to main content
Clinical Trials/NCT05593198
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.

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
July 2, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

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)

Loading locations...

Similar Trials