Alveolar Bone ResorptionNCT05613075
Effect of Hyaluronic Acid, With Demineralized Tooth Graft, in Socket Preservation, vs Demineralized Tooth Graft Alone.
A study testing tooth extraction and socket preservation with demineralized tooth graft and tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid in people with Alveolar Bone Resorption and Socket Preservation, run by Cairo University at 1 site in Egypt.
Trial summary
Many dentists, clinicians and researchers have conducted numerous trials, and put several materials and procedures under the test, in an attempt to preserve vertical and/or horizontal extraction sockets dimensions. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Resorption, Socket Preservation, Bone Resorption
- What is being tested?
- tooth extraction and socket preservation with demineralized tooth graft and tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 29 Nov 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. 18 years old or older.
- 2. Requiring alveolar preservation after tooth extraction prior to placement of dental implant.
- 3. Participants that are eligible for immediate implantation, yet having factors that are hindering these patients from immediate placement of an implant at the time of extraction (ex: Financial related factors - psychological factors - time related factors).
- 4. Motivated patients with good enough understanding of oral health measurements and importance.
- 5. Sufficient keratinized gingiva to cover the grafted bone. 6. The presence of dentition adjacent to the bone defect.
- 7. Patients who are healthy or have well-controlled systemic disease(s).
Show all 10Show fewer
- 8. Teeth extractions are to be recommended due to trauma, caries, or periodontal diseases. * 9. Single rooted teeth from both arches.
- 10. No acute infections, pus formation, socket and bony discharges.
- 11. Hopeless teeth, to be extracted, are bounded both mesially and distally by adjacent, teeth.
- 12. Intact buccal bone of the teeth to be extracted.
Who cannot join
- 1. Heavy smokers (more than 10 cigarettes per day or an electronic cigarette dose of >6 mg/ml of nicotine).
- 2. Presence of active infection or severe inflammation in the intervention zone.
- 3. Relevant medical history that contraindicates implant surgery.
- 4. Immunosuppression (eg. Hiv, solid-organ transplants). 5. Head and neck-irradiated patients in the past 5 years. 6. Regular intake of bisphosphonates, anticoagulants, or anti-inflammatories.
- 7. Chronic drug abuse or alcoholic habits. 8. Patients with poor oral hygiene (full-mouth plaque score and full-mouth bleeding score >15%) and lack of motivation.
- 9. Uncontrolled diabetes (reported levels of glycated haemoglobin exceeding 7%).
- 10. Uncontrolled and /or untreated periodontal disease. 11. Patients who had previously received bone graft on the site to be operated. 12. Patients with significant comorbidity such as recent heart attack or coagulation disorder.
- 13. Pregnant subjects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Potential Effect Assessment of Locally Applied Hyaluronic Acid, When Mixed With Autogenous De-mineralized Tooth Graft, for Socket Preservation, in Comparison With the Application of Autogenous De-mineralized Tooth Graft Alone.
Many dentists, clinicians and researchers have conducted numerous trials, and put several materials and procedures under the test, in an attempt to preserve vertical and/or horizontal extraction sockets dimensions. The clinical consequences of post-extraction remodeling may affect the outcome of the ensuing therapies aimed at restoring the lost dentition, either by limiting the bone availability for ideal implant placement or by compromising the aesthetic result of the prosthetic restorations. In an attempt for ridge/socket preservation of a freshly extracted tooth socket/bed, this study aims to assess and compare between using autogenous tooth graft added with Hyaluronic acid, and the usage of the standardized autogenous tooth graft alone, regarding the potency, preservative feature, and quality of bone healing, density, and deposition. For a better restorative outcome using a delayed implant placement later on in the edentulous area.
Read the detailed description
The available studies provide insufficient information to assess the efficacy of the usage of ha after tooth extraction in order to induce wound healing and accelerates bone deposition and differentiation. Hence, the purpose of this clinical trial is to investigate whether there is any beneficial value of local administration of 8% ha gel formulation (gengigel ®; farmalink saglik, istanbul, turkey) on the postoperative healing phase, bone density and ridge dimensions.
In an attempt for ridge/socket preservation of a freshly extracted tooth socket/bed, this study aims to assess and compare between using autogenous tooth graft added with Hyaluronic acid, and the usage of the standardized autogenous tooth graft alone, regarding the potency, preservative feature, and quality of bone healing, density, and deposition. For a better restorative outcome using a delayed implant placement later on in the e-dentulous area.
Our null hypothesis that post-extraction ridges preserved with Hyaluronic acid mixed with autogenous tooth grafts will present no significant higher bone density at extraction site, nor better dimensional preservation of the ridge tooth/teeth socket(s), vertically and/or horizontally, than the normalized/standardized ridge preservation using autogenous tooth graft particulates alone, carried to serve delayed implants placement later on, at extraction sites.
- Being tested
- tooth extraction and socket preservation with demineralized tooth graft, tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid
- Keywords
- dentin graft, autogenous tooth graft, socket preservation, hyaluronic acid
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tooth extraction and socket preservation with demineralized tooth graftProcedure or surgery
tooth extraction and socket preservation with demineralized tooth graft
tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acidProcedure or surgery
tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid
| Study group | Role | What they receive |
|---|---|---|
| tooth extraction and socket preservation with demineralized tooth graft | Active comparator | patients with immediate extraction sockets, filled and condensed with demineralized, autogenous dentinal graft particles, extracted and originated from the newly extracted tooth, then covered with biodegradable Gel foaming sponge. Receives: Procedure: tooth extraction and socket preservation with demineralized tooth graft |
| tooth extraction and socket preservation with demineralized tooth graft and hyaluronic acid | Experimental | patients with immediate extraction sockets, filled and condensed with demineralized, autogenous dentinal graft particles, extracted and originated from the newly extracted tooth, mixed with Hyaluronic acid, in gel form, as a carrier, then covered with biodegradable Gel foaming sponge. Receives: Procedure: tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
(BLRW)
Bucco-lingual alveolar ridge width
Measured: 6 months
(BRH)
Height of Buccal ridge
Measured: 6 months
(LRH).
height of Lingual ridge
Measured: 6 months
Secondary outcomes (4)
Percentage of newly formed bone
percentage of newly formed lamellar bone bundles and/or newly formed bone trabeculae
Measured: 6 months
soft tissue healing
percentage of complete post operative wound closure by soft tissues
Measured: 2 weeks
residual graft
percentage of residual bone graft particles
Measured: 6 months
Visual analogue score (VAS)
Patient's pain and discomfort, 0-10 score, 0 represents "no pain", 10 represents "as bad as possible"
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Dec 2022
- Primary completion30 Oct 2024
- Study completion29 Nov 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 Alveolar Bone ResorptionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahma Hesham Ahmed, Cairo University
- Investigators
- Rahma H Mohamed Ali, Principal investigator, Cairo University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613075
- Sponsor's protocol ID
- rahma.autograft
- Status last verified
- Jun 2025
- First submitted
- 4 Nov 2022
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hesham R, Shemais N, Saleh HA, Fawzy El-Sayed K. Autogenous Demineralized Dentin Graft With High Molecular Weight Hyaluronic Acid in Ridge Preservation: Pilot Trial. Clin Implant Dent Relat Res. 2025 Dec;27(6):e70100. doi: 10.1111/cid.70100.
PubMed 41235610
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Effect Assessment of Locally Applied Hyaluronic Acid, When Mixed With Autogenous De-mineralized Tooth Graft, for Socket Preservation, in Comparison With the Application of Autogenous De-mineralized Tooth Graft Alone.
- ClinicalTrials.gov ID
- NCT05613075
- Acronym / sponsor ID
- rahma.autograft
- Keywords
- dentin graft, autogenous tooth graft, socket preservation, hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 14 Nov 2022 (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.
Many dentists, clinicians and researchers have conducted numerous trials, and put several materials and procedures under the test, in an attempt to preserve vertical and/or horizontal extraction sockets dimensions. The clinical consequences of post-extraction remodeling may affect the outcome of the ensuing therapies aimed at restoring the lost dentition, either by limiting the bone availability for ideal implant placement or by compromising the aesthetic result of the prosthetic restorations. In an attempt for ridge/socket preservation of a freshly extracted tooth socket/bed, this study aims to assess and compare between using autogenous tooth graft added with Hyaluronic acid, and the usage of the standardized autogenous tooth graft alone, regarding the potency, preservative feature, and quality of bone healing, density, and deposition. For a better restorative outcome using a delayed implant placement later on in the edentulous area.
Detailed description
The available studies provide insufficient information to assess the efficacy of the usage of ha after tooth extraction in order to induce wound healing and accelerates bone deposition and differentiation. Hence, the purpose of this clinical trial is to investigate whether there is any beneficial value of local administration of 8% ha gel formulation (gengigel ®; farmalink saglik, istanbul, turkey) on the postoperative healing phase, bone density and ridge dimensions.
In an attempt for ridge/socket preservation of a freshly extracted tooth socket/bed, this study aims to assess and compare between using autogenous tooth graft added with Hyaluronic acid, and the usage of the standardized autogenous tooth graft alone, regarding the potency, preservative feature, and quality of bone healing, density, and deposition. For a better restorative outcome using a delayed implant placement later on in the e-dentulous area.
Our null hypothesis that post-extraction ridges preserved with Hyaluronic acid mixed with autogenous tooth grafts will present no significant higher bone density at extraction site, nor better dimensional preservation of the ridge tooth/teeth socket(s), vertically and/or horizontally, than the normalized/standardized ridge preservation using autogenous tooth graft particulates alone, carried to serve delayed implants placement later on, at extraction sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tooth extraction and socket preservation with demineralized tooth graft | Active comparator | Procedure: tooth extraction and socket preservation with demineralized tooth graftpatients with immediate extraction sockets, filled and condensed with demineralized, autogenous dentinal graft particles, extracted and originated from the newly extracted tooth, then covered with biodegradable Gel foaming sponge. |
| tooth extraction and socket preservation with demineralized tooth graft and hyaluronic acid | Experimental | Procedure: tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acidpatients with immediate extraction sockets, filled and condensed with demineralized, autogenous dentinal graft particles, extracted and originated from the newly extracted tooth, mixed with Hyaluronic acid, in gel form, as a carrier, then covered with biodegradable Gel foaming sponge. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. 18 years old or older.
- 2. Requiring alveolar preservation after tooth extraction prior to placement of dental implant.
- 3. Participants that are eligible for immediate implantation, yet having factors that are hindering these patients from immediate placement of an implant at the time of extraction (ex: Financial related factors - psychological factors - time related factors).
- 4. Motivated patients with good enough understanding of oral health measurements and importance.
- 5. Sufficient keratinized gingiva to cover the grafted bone. 6. The presence of dentition adjacent to the bone defect.
Key exclusion criteria (8 listed)
- 1. Heavy smokers (more than 10 cigarettes per day or an electronic cigarette dose of >6 mg/ml of nicotine).
- 2. Presence of active infection or severe inflammation in the intervention zone.
- 3. Relevant medical history that contraindicates implant surgery.
- 4. Immunosuppression (eg. Hiv, solid-organ transplants). 5. Head and neck-irradiated patients in the past 5 years. 6. Regular intake of bisphosphonates, anticoagulants, or anti-inflammatories.
- 7. Chronic drug abuse or alcoholic habits. 8. Patients with poor oral hygiene (full-mouth plaque score and full-mouth bleeding score >15%) and lack of motivation.
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 |
|---|---|---|
| tooth extraction and socket preservation with demineralized tooth grafttooth extraction and socket preservation with demineralized tooth graft | Procedure or surgery | tooth extraction and socket preservation with demineralized tooth graft |
| tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acidtooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid | Procedure or surgery | tooth extraction and socket preservation with demineralized tooth graft and hyaluronic acid |
Primary outcome
(BLRW)
Time frame: 6 months
Bucco-lingual alveolar ridge width
(BRH)
Time frame: 6 months
Height of Buccal ridge
(LRH).
Time frame: 6 months
height of Lingual ridge
4 secondary outcomes
Percentage of newly formed bone
Time frame: 6 months
soft tissue healing
Time frame: 2 weeks
residual graft
Time frame: 6 months
Visual analogue score (VAS)
Time frame: 2 weeks
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 5 Jun 2025.
- Derived from this study: PubMed 41235610Hesham R, Shemais N, Saleh HA, Fawzy El-Sayed K. Autogenous Demineralized Dentin Graft With High Molecular Weight Hyaluronic Acid in Ridge Preservation: Pilot Trial. Clin Implant Dent Relat Res. 2025 Dec;27(6):e70100. doi: 10.1111/cid.70100.
- Individual participant dataSharing planned: Yes
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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.
Rahma H Mohamed Ali principal investigator
Cairo University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tooth extraction and socket preservation with demineralized tooth graft and tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid in people with Alveolar Bone Resorption and Socket Preservation, run by Cairo 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 10 inclusion and 8 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 5 Jun 2025. 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?
(BLRW) (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT05613075, 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 5 Jun 2025.