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

NCT06395818 | Completed

• 1 other identifier: 6789
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Atrophy of Edentulous Alveolar Ridge

Keywords

CAD-CAM bone blocks; hyaluronic acid; histomorphometric analysis

Outcome Measures

Primary Outcomes (2)

• 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)

  6 months

• the amount of new bone formation

  core biopsy will be underwent histomorphometric analysis to determine the percentage of new bone formation (%)

  6 months

Secondary Outcomes (1)

• the sucess of dental implants

  12 months

Study Arms (2)

prefabricated CAD-CAM allogeneic bone block hydrated using hyaluronic acid

EXPERIMENTAL

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 , The block was coated with a nonporous d-PTFE membrane

Procedure: prefabricated CAD-CAM allogeneic bone block hydrated using hyaluronic acid

prefabricated CAD-CAM allogeneic bone block sterilized hydrated using saline solution

EXPERIMENTAL

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 ,The block was coated with a nonporous d-PTFE membrane

Procedure: prefabricated CAD-CAM allogeneic bone block sterilized hydrated using saline solution

Interventions

prefabricated CAD-CAM allogeneic bone block hydrated using hyaluronic acid PROCEDURE

exposure of atrophic posterior mandibular ridge, augmentation with CAD-CAM prefabricated allogenic bone block which fixed with titanium screws ,The block was coated with a nonporous d-PTFE membrane

prefabricated CAD-CAM allogeneic bone block hydrated using hyaluronic acid

prefabricated CAD-CAM allogeneic bone block sterilized hydrated using saline solution PROCEDURE

exposure of atrophic posterior mandibular ridge, augmentation with CAD-CAM prefabricated allogenic bone block which fixed with titanium screws. The block was coated with a nonporous d-PTFE membrane

prefabricated CAD-CAM allogeneic bone block sterilized hydrated using saline solution

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, 3111, Egypt

Location

Related Publications (1)

• Helal MH, Sheta MS, Alsherif AA, Hassan MA, Aboushelib MN, Ghouraba RF. The Effectiveness of Hyaluronic Acid on Prefabricated CAD CAM Bone Blocks for Ridge Augmentation: A Split Mouth Study. Clin Implant Dent Relat Res. 2025 Apr;27(2):e70035. doi: 10.1111/cid.70035.

  PMID: 40231349 DERIVED

Study Officials

• mohamed h helal, lecturer

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: using closed envelop for participants the data will be given to outcomes assessors without defining the intervention for each group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of oral medicine, periodontology, oral diagnosis and radiology department

Model Details: parallel assignment

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: March 29, 2023
• Primary Completion: April 28, 2024
• Study Completion: December 6, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

EG (1)