Bone ResorptionNCT04377256
Hyaluronic Acid Effect on Xenogenic Bone Healing
A study testing Ridge preservation: Tooth extration and immediat bone grafting in the socket in people with Bone Resorption and Tooth Loss, run by Saint-Joseph University at 2 sites in Lebanon.
Trial summary
The aim of this study is to test the hyaluronic acid hydrogel impact on the healing acceleration of xenogenic bone substitutes used in ridge preservation. Following tooth extraction, bone particles are mixed with the hyaluronic acid gel and grafted in the tooth socket. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Resorption, Tooth Loss
- What is being tested?
- Ridge preservation: Tooth extration and immediat bone grafting in the socket
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesLebanon
- Study dates
- 1 May 2020to 10 May 2021
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients in need of tooth extraction and willing to receive dental implants in the extraction site
- Presence of two mono radicular teeth in need of extraction
Who cannot join
- Patients with systemic diseases
- Patients under 8 years and above 60 years.
- Presence of endodontic or periodontal lesion in the extraction sites
Trial locations and contacts
2 sites in 1 country.
Lebanon2 sites
Saint-Joseph university
Beirut, Lebanon, 1104 2020
Universte Saint Joseph-Beyrouth
Beirut
About this study
Official title: Hyaluronic Acid Effect on Xenogenic Bone Substitutes Healing During Ridge Preservations: A Radiological and Histomorphometric Study
The aim of this study is to test the hyaluronic acid hydrogel impact on the healing acceleration of xenogenic bone substitutes used in ridge preservation.
Following tooth extraction, bone particles are mixed with the hyaluronic acid gel and grafted in the tooth socket. at the implant placement phase, a cone beam computer assisted tomography file is recorded in order to compare it with the baseline and a biopsy to evaluate the histological consequences.
- Conditions
- Bone Resorption, Tooth Loss
- Being tested
- Ridge preservation: Tooth extration and immediat bone grafting in the socket
- Keywords
- tooth extraction, ridge preservation, hyaluronic acid, dental implant
- Medical subject headings
- Bone Resorption, Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ridge preservation: Tooth extration and immediat bone grafting in the socketProcedure or surgery
Following the tooth extraction, the socket is filled with a mixture of xenogenic bone and hyaluronic acid and sealed with an epithelio-connective arrested from the maxillary palate
| Study group | Role | What they receive |
|---|---|---|
| Radiological assessement | Experimental | Two CBCTs were recorded and compared, one at the baseline and the other at 4 months post-op. The bone resorption was quantified and analyzed using ITK-SNAP software Receives: Procedure: Ridge preservation: Tooth extration and immediat bone grafting in the socket |
| Histomorphometric analysis | Experimental | During implant placement (4 months after the bone grafting), a bone biopsy is collected and stained with several colorants to analyze the biological bone healing Receives: Procedure: Ridge preservation: Tooth extration and immediat bone grafting in the socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological assessement of the boe resorption
the baseline if the CBCT is compared to the 4 months post-op to assess the bone resorption
Measured: 4 months
Histomorphometric analysis
During implant placement, a bone biopsy is harvested and stained with different colorants to assess microscopically the biological healing
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 May 2020
- Primary completion10 Jan 2021
- Study completion10 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone ResorptionStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald J Younes, Phd, Study director, Head of oral surgery department, facuty of dentistry ,Universite SainT Joseph-BeyrouthBachar A Husseini, DDS, Principal investigator, Department of oral surgery, facuty of dentistry ,Universite SainT Joseph-Beyrouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377256
- Sponsor's protocol ID
- USJ-2019-267
- Status last verified
- Mar 2025
- First submitted
- 3 May 2020
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyaluronic Acid Effect on Xenogenic Bone Substitutes Healing During Ridge Preservations: A Radiological and Histomorphometric Study
- ClinicalTrials.gov ID
- NCT04377256
- Acronym / sponsor ID
- USJ-2019-267
- Conditions
- Bone Resorption, Tooth Loss
- Keywords
- tooth extraction, ridge preservation, hyaluronic acid, dental implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 10 Jan 2021 (actual)
- Study completion
- 10 May 2021 (actual)
- First posted
- 6 May 2020 (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.
The aim of this study is to test the hyaluronic acid hydrogel impact on the healing acceleration of xenogenic bone substitutes used in ridge preservation.
Following tooth extraction, bone particles are mixed with the hyaluronic acid gel and grafted in the tooth socket. at the implant placement phase, a cone beam computer assisted tomography file is recorded in order to compare it with the baseline and a biopsy to evaluate the histological consequences.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiological assessement | Experimental | Procedure: Ridge preservation: Tooth extration and immediat bone grafting in the socketTwo CBCTs were recorded and compared, one at the baseline and the other at 4 months post-op. The bone resorption was quantified and analyzed using ITK-SNAP software |
| Histomorphometric analysis | Experimental | Procedure: Ridge preservation: Tooth extration and immediat bone grafting in the socketDuring implant placement (4 months after the bone grafting), a bone biopsy is collected and stained with several colorants to analyze the biological bone healing |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients in need of tooth extraction and willing to receive dental implants in the extraction site
- Presence of two mono radicular teeth in need of extraction
Key exclusion criteria (3 listed)
- Patients with systemic diseases
- Patients under 8 years and above 60 years.
- Presence of endodontic or periodontal lesion in the extraction sites
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 |
|---|---|---|
| Ridge preservation: Tooth extration and immediat bone grafting in the socketFollowing the tooth extraction, the socket is filled with a mixture of xenogenic bone and hyaluronic acid and sealed with an epithelio-connective arrested from the maxillary palate | Procedure or surgery | Histomorphometric analysis, Radiological assessement |
Primary outcome
Radiological assessement of the boe resorption
Time frame: 4 months
the baseline if the CBCT is compared to the 4 months post-op to assess the bone resorption
Histomorphometric analysis
Time frame: 4 months
During implant placement, a bone biopsy is harvested and stained with different colorants to assess microscopically the biological healing
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 3 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Bone Resorption
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Active, not recruiting
Optimal Meals to Reduce Bone Resorption in Women With Osteopenia
Osteopenia
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
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.
Ronald J Younes, Phd study director
Head of oral surgery department, facuty of dentistry ,Universite SainT Joseph-Beyrouth
Bachar A Husseini, DDS principal investigator
Department of oral surgery, facuty of dentistry ,Universite SainT Joseph-Beyrouth
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ridge preservation: Tooth extration and immediat bone grafting in the socket in people with Bone Resorption and Tooth Loss, run by Saint-Joseph University at 2 sites in Lebanon.
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 2 inclusion and 3 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 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lebanon. 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?
Radiological assessement of the boe resorption (time frame: 4 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?
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 3 Apr 2025.