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

The Effectiveness of Hyaluronic Acid on Prefabricated CAD CAM Bone Blocks for Ridge Augmentation: A Split Mouth Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06395818
Enrollment
10
Registered
2024-05-02
Start date
2023-03-29
Completion date
2024-12-06
Last updated
2024-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrophy of Edentulous Alveolar Ridge

Keywords

CAD-CAM bone blocks, hyaluronic acid, histomorphometric analysis

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.

Interventions

PROCEDUREprefabricated 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

PROCEDUREprefabricated 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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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

Intervention model description

parallel assignment

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes

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,)

Design outcomes

Primary

MeasureTime frameDescription
the amount of new bone formation6 monthscore biopsy will be underwent histomorphometric analysis to determine the percentage of new bone formation (%)
measurement the width and the height of the alveolar ridge6 monthsusing CBCT the width and the height will be measured with measuring tools in milimeter (mm)

Secondary

MeasureTime frameDescription
the sucess of dental implants12 monthsusingCBCT to determine the amount of marginal bone loss in (mm)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026