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Completed

NCT Number: NCT06395818

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

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

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Tanta University

Tanta, 3111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,)

Treatment and study plan

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 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

Primary outcomes

  1. measurement the width and the height of the alveolar ridge

    Time frame: 6 months

    using CBCT the width and the height will be measured with measuring tools in milimeter (mm)

  2. the amount of new bone formation

    Time frame: 6 months

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

Secondary outcomes

  1. the sucess of dental implants

    Time frame: 12 months

    usingCBCT to determine the amount of marginal bone loss in (mm)

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 2, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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