Comparative StudyPhase 1/2NCT06229561
Soft Tissue Graft Versus Acellular Dermal Matrix in Preservation of Buccal Plate of Bone
A Phase 1/2 study testing Acellular Dermal Matrix in people with Comparative Study, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
Comparative study between 2 groups to assess the feasibility of using Acellular dermal matrix vs Soft tissue Graft after immediate implant placement Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Comparative Study
- What is being tested?
- Acellular Dermal Matrix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jan 2020to 20 May 2023
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically free
Who cannot join
- Heavy smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Soft Tissue Graft Versus Acellular Dermal Matrix in Preservation of Buccal Plate of Bone After Immediate Implant Placement
Comparative study between 2 groups to assess the feasibility of using Acellular dermal matrix vs Soft tissue Graft after immediate implant placement
Read the detailed description
It was conclude that SCTG is the gold standard for soft tissue augmentation up till now, However ADM can be alternative to autogenous soft tissue graft.
- Conditions
- Comparative Study
- Being tested
- Acellular Dermal Matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular Dermal MatrixCombination product
Feasibility of soft tissue graft after immediate implant placement
| Study group | Role | What they receive |
|---|---|---|
| ADM and SCTG | Experimental | ADM and SCTG Receives: Combination Product: Acellular Dermal Matrix |
| Acellular Dermal Matrix and soft tissue graft | Experimental | 12participatent in two groups Receives: Combination Product: Acellular Dermal Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buccal bone thickness
Assess the buccal bone thickness before and after the graft application
Measured: 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start18 Jan 2020
- Primary completion20 Nov 2022
- Study completion20 May 2023
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 Comparative StudyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nehal Mohamed Ibrahim Abbas, Faculty of Dental Medicine for Girls
- Investigators
- Azhar Journal, Principal investigator, No affliction
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229561
- Sponsor's protocol ID
- Nmohamed
- Status last verified
- Jan 2024
- First submitted
- 29 Dec 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Soft tissue graft versus acellular dermal matrix in preservation of buccal plate of bone after immediate implant placement
Publications
Elaskary A, Abdelrahman H, Elfahl B, Elsabagh H, El-Kimary G, Ghallab NA. Immediate Implant Placement in Intact Fresh Extraction Sockets Using Vestibular Socket Therapy Versus Partial Extraction Therapy in the Esthetic Zone: A Randomized Clinical Trial. Int J Oral Maxillofac Implants. 2023 May, Jun;38(3):468-478. doi: 10.11607/jomi.9973.
PubMed 37279214
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Graft Versus Acellular Dermal Matrix in Preservation of Buccal Plate of Bone After Immediate Implant Placement
- ClinicalTrials.gov ID
- NCT06229561
- Acronym / sponsor ID
- Nmohamed
- Conditions
- Comparative Study
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 18 Jan 2020 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 29 Jan 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.
Comparative study between 2 groups to assess the feasibility of using Acellular dermal matrix vs Soft tissue Graft after immediate implant placement
Detailed description
It was conclude that SCTG is the gold standard for soft tissue augmentation up till now, However ADM can be alternative to autogenous soft tissue graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADM and SCTG | Experimental | Combination Product: Acellular Dermal MatrixADM and SCTG |
| Acellular Dermal Matrix and soft tissue graft | Experimental | Combination Product: Acellular Dermal Matrix12participatent in two groups |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Medically free
Key exclusion criteria (1 listed)
- Heavy smoking
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 |
|---|---|---|
| Acellular Dermal MatrixFeasibility of soft tissue graft after immediate implant placement | Combination product | ADM and SCTG, Acellular Dermal Matrix and soft tissue graft |
Primary outcome
Buccal bone thickness
Time frame: 6 months follow up
Assess the buccal bone thickness before and after the graft application
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 29 Jan 2024.
- Results publication: PubMed 37279214Elaskary A, Abdelrahman H, Elfahl B, Elsabagh H, El-Kimary G, Ghallab NA. Immediate Implant Placement in Intact Fresh Extraction Sockets Using Vestibular Socket Therapy Versus Partial Extraction Therapy in the Esthetic Zone: A Randomized Clinical Trial. Int J Oral Maxillofac Implants. 2023 May, Jun;38(3):468-478. doi: 10.11607/jomi.9973.
- Individual participant dataSharing planned: Yes. Soft tissue graft versus acellular dermal matrix in preservation of buccal plate of bone after immediate implant placement
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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.
Azhar Journal principal investigator
No affliction
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Acellular Dermal Matrix in people with Comparative Study, 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 1 inclusion and 1 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 29 Jan 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Buccal bone thickness (time frame: 6 months follow up). 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 NCT06229561, 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 29 Jan 2024.