Hyaluronic Acid Gel for Preservation the Extraction SocketPhase 4NCT06176937
Hyaluronic Acid Gel in Ridge Preservation
A Phase 4 study testing Hyaluronic acid and empty socket in people with Hyaluronic Acid Gel for Preservation the Extraction Socket, run by Ain Shams University at 1 site in Egypt.
Trial summary
hyaluronic acid gel applied at the extraction socket after extraction immediately to preserve the socket from post extraction resorption. hyaluronic acid has ability for osteogenesis and new bone formation. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Hyaluronic Acid Gel for Preservation the Extraction Socket
- What is being tested?
- Hyaluronic acid and empty socket
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Oct 2021to 20 Aug 2022
- Phase
- Phase 4
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire
- Both genders.
- Age from 20 -50 years old.
- Having at least one hopeless teeth indicated for extraction.
- Esthetic zone teeth (anterior or premolar).
- Sockets type 1 or 2 .
- Patient should agree to sign a written consent after the nature of the study will be explained.
- -
Who cannot join
- 1- Smokers. 2- Pregnant and breast-feeding females. 3- Mentally retarded Patients. 4- Prisoners and handicapped patients. 5- Patients with malocclusion.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Hyaluronic Acid Gel in Ridge Preservation After Tooth Extraction: A Randomized Controlled Clinical Trial With Radiographic and Histomorphometric Study
hyaluronic acid gel applied at the extraction socket after extraction immediately to preserve the socket from post extraction resorption. hyaluronic acid has ability for osteogenesis and new bone formation.
Read the detailed description
twenty-four patients with one hopeless tooth at least, first CBCt before extraction to evaluate the dimension of the socket, then atraumatic extraction of the tooth to preserve the bony wall of the socket, after extraction and curettage the socket applied hyaluronic acid gel inside the socket and applied collagen membrane to secure the socket. After 4 months of extraction, CBCt was done to evaluate the dimension of the socket and the effect of hyaluronic acid. Furthermore, The core biopsy was taken by trephine bur at the time of implant placement for evaluate the histological appearance of the bone to evaluate the secondary outcome. then after three months the crown was delivered as a prosthetic part.
- Being tested
- Hyaluronic acid, empty socket
- Keywords
- hopeless anterior tooth, atraumatic extraction, hyaluronic acid gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acidDrug
Alveolar ridge preservation by atraumatic tooth extraction and socket curettage then application hyaluronic acid gel after extraction and covering the socket by collagen membrane.
empty socketOther
Alveolar ridge preservation by atraumatic tooth socket without application any drug but just covering the socket by collagen membrane.
| Study group | Role | What they receive |
|---|---|---|
| hyaluronic acid gel | Active comparator | Hyaluronic acid considers as a high molecular weight glycosaminoglycan (GAG) consists of multiple disaccharide non-sulfated units of D-glucuronic acid and N-acetylglucosamine Receives: Drug: Hyaluronic acid |
| empty socket | Other | extraction socket without application any drug Receives: Other: empty socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical outcome
measurement clinical bone width of the socket by millimeter before and 4 months after extraction ...
Measured: baseline(before extraction)/ four months later after extraction
Radiographic measurement
Radiographic measurement of bone width by CBCt before and 4 months after extraction
Measured: baseline(before extraction)/ four months later after extraction
Radiographic measurement
Radiographic measurement of bone height by CBCt before and 4 months after extraction.
Measured: baseline (before extraction)/ four months later after extraction
Secondary outcomes (2)
histological analysis
The bone biopsy will be taken by trephine bur. And evaluate bone quality.
Measured: after 4 months of extraction at the time of implant placement.
histomorphometric analysis
The bone biopsy will be taken by trephine bur. And evaluate bone quantity.
Measured: after 4 months of extraction at the time of implant placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start13 Oct 2021
- Primary completion26 Feb 2022
- Study completion20 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyaluronic Acid Gel for Preservation the Extraction SocketStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzan M Ibrahim, professor, Study director, Faculty of dentistry-Ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176937
- Sponsor's protocol ID
- FD-ASU-REC.852
- Status last verified
- Jan 2020
- First submitted
- 13 Sep 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hyaluronic Acid Gel in Ridge Preservation After Tooth Extraction: A Randomized Controlled Clinical Trial With Radiographic and Histomorphometric Study
- ClinicalTrials.gov ID
- NCT06176937
- Acronym / sponsor ID
- FD-ASU-REC.852
- Keywords
- hopeless anterior tooth, atraumatic extraction, hyaluronic acid gel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 26 Feb 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 20 Dec 2023 (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.
hyaluronic acid gel applied at the extraction socket after extraction immediately to preserve the socket from post extraction resorption. hyaluronic acid has ability for osteogenesis and new bone formation.
Detailed description
twenty-four patients with one hopeless tooth at least, first CBCt before extraction to evaluate the dimension of the socket, then atraumatic extraction of the tooth to preserve the bony wall of the socket, after extraction and curettage the socket applied hyaluronic acid gel inside the socket and applied collagen membrane to secure the socket. After 4 months of extraction, CBCt was done to evaluate the dimension of the socket and the effect of hyaluronic acid. Furthermore, The core biopsy was taken by trephine bur at the time of implant placement for evaluate the histological appearance of the bone to evaluate the secondary outcome. then after three months the crown was delivered as a prosthetic part.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyaluronic acid gel | Active comparator | Drug: Hyaluronic acidHyaluronic acid considers as a high molecular weight glycosaminoglycan (GAG) consists of multiple disaccharide non-sulfated units of D-glucuronic acid and N-acetylglucosamine |
| empty socket | Other | Other: empty socketextraction socket without application any drug |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire
- Both genders.
- Age from 20 -50 years old.
- Having at least one hopeless teeth indicated for extraction.
- Esthetic zone teeth (anterior or premolar).
Key exclusion criteria (2 listed)
- 1- Smokers. 2- Pregnant and breast-feeding females. 3- Mentally retarded Patients. 4- Prisoners and handicapped patients. 5- Patients with malocclusion.
- -
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 |
|---|---|---|
| Hyaluronic acidAlveolar ridge preservation by atraumatic tooth extraction and socket curettage then application hyaluronic acid gel after extraction and covering the socket by collagen membrane. | Drug | hyaluronic acid gel |
| empty socketAlveolar ridge preservation by atraumatic tooth socket without application any drug but just covering the socket by collagen membrane. | Other | empty socket |
Primary outcome
clinical outcome
Time frame: baseline(before extraction)/ four months later after extraction
measurement clinical bone width of the socket by millimeter before and 4 months after extraction ...
Radiographic measurement
Time frame: baseline(before extraction)/ four months later after extraction
Radiographic measurement of bone width by CBCt before and 4 months after extraction
Radiographic measurement
Time frame: baseline (before extraction)/ four months later after extraction
Radiographic measurement of bone height by CBCt before and 4 months after extraction.
2 secondary outcomes
histological analysis
Time frame: after 4 months of extraction at the time of implant placement.
histomorphometric analysis
Time frame: after 4 months of extraction at the time of implant placement.
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 20 Dec 2023.
Related trials for Hyaluronic Acid Gel for Preservation the Extraction Socket
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Improving Healing in Children After Tooth Extraction Using Laser Therapy or Hyaluronic Acid
Mesh, Healthy Volunteer
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.
Suzan M Ibrahim, professor study director
Faculty of dentistry-Ain shams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyaluronic acid and empty socket in people with Hyaluronic Acid Gel for Preservation the Extraction Socket, run by Ain Shams 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 8 inclusion and 2 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 20 Dec 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
clinical outcome (time frame: baseline(before extraction)/ four months later after extraction). The study lists 3 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 20 Dec 2023.