Clinical trial NCT06395818: the Effect of Hyaluronic Acid on a Prefabricated CAD-CAM Bone Blocks for Ridge Augmentation
Official title: The Effectiveness of Hyaluronic Acid on Prefabricated CAD CAM Bone Blocks for Ridge Augmentation: A Split Mouth Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrophy of Edentulous Alveolar Ridge
Keywords: CAD-CAM bone blocks
hyaluronic acid
histomorphometric analysis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel assignment
Primary purpose: TREATMENT

Brief summary: Each patient will receive 2 prefabricated CAD-CAM allogeneic bone blocks sterilized with gamma rays with different rehydration methods.

Side I: prefabricated CAD-CAM allogeneic bone block sterilized with gamma rays hydrated using hyaluronic acid \* Side II: prefabricated CAD-CAM allogeneic bone block sterilized with gamma rays hydrated using saline solution Both blocks are fixed with osteosynthesis screws, covered with non resorbable membranes\*\* The membranes will be removed after 6 months, dental implants will be placed and core biopsy will be collected from the site of the implant placement for histologic evaluation

Detailed description: 10 patients will be included in this study with bilateral atrophic posterior mandible for split mouth research

. group I: prefabricated CAD-CAM allogeneic bone block sterilized with gamma rays hydrated using hyaluronic acid group II: prefabricated CAD-CAM allogeneic bone block sterilized with gamma rays hydrated using saline solution under LA mucoperiosteal flap will be elevated to expose the atrophic ridge then the prefabricated CAD-CAM allogenic block either mixed with hyaluronic acid (group I) or saline (group II) will be fixed in its position with titanium miniscrews , The block was coated with a nonporous d-PTFE membrane then closure of flap with nylon second stage: 6 months later exposure of alveolar ridge core biopsy was taken for histological study then insertion of titanium implants.

the aim of the study is to investigate the effect of hyaluronic acid on a prefabricated CAD- CAM bone blocks for ridge augmentation radiographically and histologically.

Eligibility criteria: Inclusion criteria:

* Patients between 40 to 65 years old.
* Posterior atrophic mandibular ridge indicated for horizontal and vertical ridge augmentation for dental implant placement.
* Good oral hygiene

Exclusion Criteria:

* Systemic diseases that affect host healing responses.
* Heavy smoking.
* Poor oral hygiene.
* Traumatic occlusion, sever para-functional habits (ex. bruxism, clenching,)

Primary outcomes:
measure: measurement the width and the height of the alveolar ridge
timeFrame: 6 months
measure: the amount of new bone formation
timeFrame: 6 months
Secondary outcomes:
measure: the sucess of dental implants
timeFrame: 12 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Dentistry, Tanta University
Study officials:
affiliation: Tanta University
name: mohamed h helal, lecturer
role: PRINCIPAL_INVESTIGATOR
References: