Bone LossPhase 3NCT06853392
Socket Preservation Using Dentin Graft Autogenous Dentin Graft With Collagen Sponge on Dental Implant Stability AUTOGENOUS TOOTH GRAFT WITH COLLAGEN SPONGE ON DENTAL IMPLANT STABILITY
A Phase 3 study testing Demineralized freeze dried allograft with collagen sponge and autogenous dentin graft with collagen sponge in people with Bone Loss and Bone Remodeling Disorder, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
The present study was performed to evaluate socket preservation using collagen sponge with autogenous dentin graft versus collagen sponge with de-mineralised freez-dried bone graft on dental implant stability Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Bone Remodeling Disorder, Bone Resorption
- What is being tested?
- Demineralized freeze dried allograft with collagen sponge and autogenous dentin graft with collagen sponge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2023to 1 Jun 2024
- Phase
- Phase 3
- 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 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients are free from any systemic diseases.
- Patients with good oral hygiene.
- Age range from 25-50 years.
- Adequate inter arch space .
Who cannot join
- Medications that may affect bone turnover, and bone metabolic diseases.
- Smoker patients and alcoholics.
- Patients with parafunctional habits.
- Patients with active acute infection related to tooth of interest.
- Patients with a lack of compliance, and serious mental or psychological problems.
- Pregnant females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Socket Preservation Using Autogenous Dentin Graft With Collagen Sponge on Dental Implant Stability
The present study was performed to evaluate socket preservation using collagen sponge with autogenous dentin graft versus collagen sponge with de-mineralised freez-dried bone graft on dental implant stability
Read the detailed description
in our study we made socket preservation using two different grafts in two groups.
before grafting we took CBCT
we used autogenous dentin graft covered by collagen sponge in one group and demineralized freeze - dried allograft covered with collagen sponge in the other group.
after 6 months we Took another CBCT to assist the dimensional changes and bone density in the alveolar socket after grafting We inserted the implant and during insertion we took a core biopsy with trephine bur with external diameter 3 mm for histological analysis.
After implant insertion we assisted the stability using RFA.
- Conditions
- Bone Loss, Bone Remodeling Disorder, Bone Resorption
- Being tested
- Demineralized freeze dried allograft with collagen sponge, autogenous dentin graft with collagen sponge
- Keywords
- socket preservation, alveolar ridge defect, Dentin graft, Demineralized freeze dried allograft
- Medical subject headings
- Bone Diseases, Metabolic, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demineralized freeze dried allograft with collagen spongeCombination product
Also called DFDBA
Demineralized freeze dried allograft,filling 2/3 of the socket covered with collagen sponge ,six months, one time
autogenous dentin graft with collagen spongeCombination product
Also called ADG
autogenous mineralized dentin graft, filling 2/3 of the socket covered with collagen sponge , six months, one time
| Study group | Role | What they receive |
|---|---|---|
| demineralized freeze dried allograft | Active comparator | demineralized freeze dried allograft with collagen sponge Receives: Combination Product: Demineralized freeze dried allograft with collagen sponge |
| autogenous dentin graft | Active comparator | Autogenous dentin graft with collagen sponge Receives: Combination Product: autogenous dentin graft with collagen sponge |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in radiographic Socket dimensions from base line to 6 months
CBCT measuring socket dimensions
Measured: 6 months following the end of treatment
change in bone density from base line to 6 months
CBCT measuring bone density within the socket
Measured: 6 months following the end of treatment
Secondary outcomes (2)
new bone formation
Histological analysis for new bone formation by masson trichrome
Measured: after six months at the time of implant placement
implant stability
measuring primary Implant Stability by resonance frequency analysis
Measured: after six months 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 posted3 Mar 2025
- Study start15 Sep 2023
- Primary completion1 Apr 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- test group :socket preservation by dentin graft covered with collagen sponge control group :socket preservation by demineralized freeze dried allograft covered by collagen sponge
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Collaborators
- Beni-Suef University
- Responsible party
- Principal investigator, Amira Ali El said, Faculty of Dental Medicine for Girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853392
- Sponsor's protocol ID
- P-ME-23-02
- Status last verified
- Feb 2025
- First submitted
- 27 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Socket Preservation Using Autogenous Dentin Graft With Collagen Sponge on Dental Implant Stability
- ClinicalTrials.gov ID
- NCT06853392
- Acronym / sponsor ID
- P-ME-23-02
- Conditions
- Bone Loss, Bone Remodeling Disorder, Bone Resorption
- Keywords
- socket preservation, alveolar ridge defect, Dentin graft, Demineralized freeze dried allograft
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Collaborators
- Beni-Suef University
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 3 Mar 2025 (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 present study was performed to evaluate socket preservation using collagen sponge with autogenous dentin graft versus collagen sponge with de-mineralised freez-dried bone graft on dental implant stability
Detailed description
in our study we made socket preservation using two different grafts in two groups.
before grafting we took CBCT
we used autogenous dentin graft covered by collagen sponge in one group and demineralized freeze - dried allograft covered with collagen sponge in the other group.
after 6 months we Took another CBCT to assist the dimensional changes and bone density in the alveolar socket after grafting We inserted the implant and during insertion we took a core biopsy with trephine bur with external diameter 3 mm for histological analysis.
After implant insertion we assisted the stability using RFA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- test group :socket preservation by dentin graft covered with collagen sponge control group :socket preservation by demineralized freeze dried allograft covered by collagen sponge
| Arm | Type | Receives |
|---|---|---|
| demineralized freeze dried allograft | Active comparator | Combination Product: Demineralized freeze dried allograft with collagen spongedemineralized freeze dried allograft with collagen sponge |
| autogenous dentin graft | Active comparator | Combination Product: autogenous dentin graft with collagen spongeAutogenous dentin graft with collagen sponge |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients are free from any systemic diseases.
- Patients with good oral hygiene.
- Age range from 25-50 years.
- Adequate inter arch space .
Key exclusion criteria (6 listed)
- Medications that may affect bone turnover, and bone metabolic diseases.
- Smoker patients and alcoholics.
- Patients with parafunctional habits.
- Patients with active acute infection related to tooth of interest.
- Patients with a lack of compliance, and serious mental or psychological problems.
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 |
|---|---|---|
| Demineralized freeze dried allograft with collagen spongeAlso: DFDBADemineralized freeze dried allograft,filling 2/3 of the socket covered with collagen sponge ,six months, one time | Combination product | demineralized freeze dried allograft |
| autogenous dentin graft with collagen spongeAlso: ADGautogenous mineralized dentin graft, filling 2/3 of the socket covered with collagen sponge , six months, one time | Combination product | autogenous dentin graft |
Primary outcome
change in radiographic Socket dimensions from base line to 6 months
Time frame: 6 months following the end of treatment
CBCT measuring socket dimensions
change in bone density from base line to 6 months
Time frame: 6 months following the end of treatment
CBCT measuring bone density within the socket
2 secondary outcomes
new bone formation
Time frame: after six months at the time of implant placement
implant stability
Time frame: after six months 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 3 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Demineralized freeze dried allograft with collagen sponge and autogenous dentin graft with collagen sponge in people with Bone Loss and Bone Remodeling Disorder, run by Faculty of Dental Medicine for Girls 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 4 inclusion and 6 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 Mar 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
change in radiographic Socket dimensions from base line to 6 months (time frame: 6 months following the end of treatment). 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 Mar 2025.