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

NCT ID: NCT06395818

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-29

Study Completion Date

2024-12-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrophy of Edentulous Alveolar Ridge

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

CAD-CAM bone blocks hyaluronic acid histomorphometric analysis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
using closed envelop for participants the data will be given to outcomes assessors without defining the intervention for each group

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

prefabricated CAD-CAM allogeneic bone block hydrated using hyaluronic acid

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

Group Type EXPERIMENTAL

prefabricated CAD-CAM allogeneic bone block hydrated using hyaluronic acid

Intervention Type 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

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

Group Type EXPERIMENTAL

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

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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,)
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tanta University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Hamdy Helal

lecturer of oral medicine, periodontology, oral diagnosis and radiology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

mohamed h helal, lecturer

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Dentistry, Tanta University

Tanta, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40231349 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

6789

Identifier Type: -

Identifier Source: org_study_id