the Effect of Hyaluronic Acid on a Prefabricated CAD-CAM Bone Blocks for Ridge Augmentation

Atrophy of Edentulous Alveolar Ridge Clinical Trial

Official title:

the Effect of Hyaluronic Acid on a Prefabricated CAD-CAM Bone Blocks for Ridge Augmentation Radiographically and Histologically

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06395818
• Other study ID #: 6789
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 29, 2023
• Est. completion date: June 26, 2024

Study information

• Verified date: April 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 5 months, dental implants will be placed and core biopsy will be collected from the site of the implant placement for histologic evaluation

Description:

12 patients will be included in this study with bilateral atrophic posterior mandible for split mouth research . 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 under LA mucoperiosteal flap will be elevated to expose the atrophic ridge then the prefabricated CAD-CAM allogenic block will be fixed in its position with titanium miniscrews , autogenous bone graft will be taken from the ramus and either mixed with hyaluronic acid (side I) or saline (side II) to cover the allogenic block then closure of flap with nylon second stage: 5 months later exposure of alveolar ridge core biopsy was takrn 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: June 26, 2024
• Est. primary completion date: April 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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,)

Related Conditions & MeSH terms

• Atrophy
• Atrophy of Edentulous Alveolar Ridge

Intervention

Procedure:
• prefabricated CAD-CAM allogeneic bone block hydrated using hyaluronic acid
exposure of atrophic posterior mandibular ridge, augmentation with CAD-CAM prefabricated allogenic bone block which fixed with titanium screws then covered with particulate autogenous graft taken from ramus and mixed with hyaluronic acid
• prefabricated CAD-CAM allogeneic bone block sterilized hydrated using saline solution
exposure of atrophic posterior mandibular ridge, augmentation with CAD-CAM prefabricated allogenic bone block which fixed with titanium screws then covered with particulate autogenous graft taken from ramus and mixed with saline solution

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Tanta University	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement the width and the height of the alveolar ridge	using CBCT the width and the height will be measured with measuring tools in milimeter (mm)	5 months
Primary	the amount of new bone formation	core biopsy will be underwent histomorphometric analysis to determine the percentage of new bone formation (%)	5 months
Secondary	the sucess of dental implants	usingCBCT to determine the amount of marginal bone loss in (mm)	six months