Atrophy of Edentulous Alveolar RidgeNCT06395818
the Effect of Hyaluronic Acid on a Prefabricated CAD-CAM Bone Blocks for Ridge Augmentation
A study testing prefabricated CAD-CAM allogeneic bone block hydrated using hyaluronic acid and prefabricated CAD-CAM allogeneic bone block sterilized hydrated using saline solution in people with Atrophy of Edentulous Alveolar Ridge, run by Tanta University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophy of Edentulous Alveolar Ridge
- What is being tested?
- prefabricated CAD-CAM allogeneic bone block hydrated using hyaluronic acid and prefabricated CAD-CAM allogeneic bone block sterilized hydrated using saline solution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Mar 2023to 6 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Systemic diseases that affect host healing responses.
- Heavy smoking.
- Poor oral hygiene.
- Traumatic occlusion, sever para-functional habits (ex. bruxism, clenching,)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Hyaluronic Acid on Prefabricated CAD CAM Bone Blocks for Ridge Augmentation: A Split Mouth Study
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
Read the 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.
- Conditions
- Atrophy of Edentulous Alveolar Ridge
- Being tested
- prefabricated CAD-CAM allogeneic bone block hydrated using hyaluronic acid, prefabricated CAD-CAM allogeneic bone block sterilized hydrated using saline solution
- Keywords
- CAD-CAM bone blocks, hyaluronic acid, histomorphometric analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prefabricated CAD-CAM allogeneic bone block hydrated using hyaluronic acidProcedure or surgery
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 solutionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: prefabricated CAD-CAM allogeneic bone block sterilized hydrated using saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
the amount of new bone formation
core biopsy will be underwent histomorphometric analysis to determine the percentage of new bone formation (%)
Measured: 6 months
Secondary outcomes (1)
the sucess of dental implants
usingCBCT to determine the amount of marginal bone loss in (mm)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start29 Mar 2023
- Primary completion28 Apr 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrophy of Edentulous Alveolar RidgeStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hamdy Helal, Tanta University
- Investigators
- mohamed h helal, lecturer, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395818
- Sponsor's protocol ID
- 6789
- Status last verified
- Dec 2024
- First submitted
- 29 Apr 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40231349
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Hyaluronic Acid on Prefabricated CAD CAM Bone Blocks for Ridge Augmentation: A Split Mouth Study
- ClinicalTrials.gov ID
- NCT06395818
- Acronym / sponsor ID
- 6789
- Conditions
- Atrophy of Edentulous Alveolar Ridge
- Keywords
- CAD-CAM bone blocks, hyaluronic acid, histomorphometric analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 28 Apr 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel assignment
| Arm | Type | Receives |
|---|---|---|
| prefabricated CAD-CAM allogeneic bone block hydrated using hyaluronic acid | Experimental | Procedure: prefabricated CAD-CAM allogeneic bone block hydrated using hyaluronic acidmucoperiosteal 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 |
| prefabricated CAD-CAM allogeneic bone block sterilized hydrated using saline solution | Experimental | Procedure: prefabricated CAD-CAM allogeneic bone block sterilized hydrated using saline solutionmucoperiosteal 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 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Systemic diseases that affect host healing responses.
- Heavy smoking.
- Poor oral hygiene.
- Traumatic occlusion, sever para-functional habits (ex. bruxism, clenching,)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prefabricated CAD-CAM allogeneic bone block hydrated using hyaluronic acidexposure 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 | Procedure or surgery | prefabricated CAD-CAM allogeneic bone block hydrated using hyaluronic acid |
| prefabricated CAD-CAM allogeneic bone block sterilized hydrated using saline solutionexposure 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 | Procedure or surgery | prefabricated CAD-CAM allogeneic bone block sterilized hydrated using saline solution |
Primary outcome
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)
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 (%)
1 secondary outcome
the sucess of dental implants
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Derived from this study: PubMed 40231349Helal 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.
Related trials for Atrophy of Edentulous Alveolar Ridge
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Active, not recruiting
Osseodensification for Narrow Alveolar Ridge Expansion
Osseodensification, Bone Expansion
Recruiting
Crestal Bone Loss Around Narrow Diameter Implants Versus Standard Diameter Implants With Bone Augmentation in Horizontally Deficient Posterior Mandibular Sites.
Horizontal Atrophy of Edentulous Alveolar Ridge
Recruiting
Freeze-dried Bone Allograft vs Autologous Bone Blocks in the Lateral Augmentation of the Jaws
Edentulous Alveolar Ridge, Edentulous Alveolar Ridge Atrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mohamed h helal, lecturer principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prefabricated CAD-CAM allogeneic bone block hydrated using hyaluronic acid and prefabricated CAD-CAM allogeneic bone block sterilized hydrated using saline solution in people with Atrophy of Edentulous Alveolar Ridge, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement the width and the height of the alveolar ridge (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06395818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.