Atrophy; Bone
Conditions
Keywords
Bone Regeneration
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.
Interventions
PROCEDUREKhoury technique
the bone block will be used following the principles of the Khoury technique to augment the bone volume.
PROCEDUREGuided bone regeneration
the membrane and the bone granules will be used to perform the guided bone regeneration technique.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone volume | 6 Months follow up | the bone volume will be analyzed with the Cone Beam Computed Tomography scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Periodontal parameters | 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. |
| Wound healing | 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. |
| Histological analysis | 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. |
Countries
Italy
Outcome results
None listed