Alveolar Ridge PreservationNCT04824235
Alveolar Ridge Preservation Using Amniotic Chorion Membrane
A study testing Amniotic Chorion Membrane and Bio-Oss xenograft and Amniotic Chorion Membrane only in people with Alveolar Ridge Preservation, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
the present study is to compare the amniotic chorion membrane (ACM) alone versus the amniotic chorion membrane combined with xenograft for their efficacy in alveolar ridge preservation procedures regarding volumetric changes assessed by cone beam computed tomography (CBCT). Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Alveolar Ridge Preservation
- What is being tested?
- Amniotic Chorion Membrane and Bio-Oss xenograft and Amniotic Chorion Membrane only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 1 Jun 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients require extraction of a non-restorable (premolar or anterior tooth) located in the maxillary arch and needs implant restoration.
- Type two sockets will be selected as revealed by Cone beam computed tomography(CBCT)
- Absence of any systemic disease or drugs that contraindicate oral surgery using Modified Cornell Medical Index
- Male and female within age range of 20-45 years.
Who cannot join
- Smokers.
- Patients with poor oral hygiene or non-compliant patients who are not willing to perform oral hygiene measures.
- Pregnant and breast-feeding females.
- Patients with acute peri-apical infection or sinus tract.
- Vulnerable group of patients as handicapped patients, orphans,prisoners,etc
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alveolar Ridge Preservation Using Amniotic Chorion Membrane Alone or Combined With Xenograft (A Randomized Controlled Clinical Trial With Histological Evaluation)
the present study is to compare the amniotic chorion membrane (ACM) alone versus the amniotic chorion membrane combined with xenograft for their efficacy in alveolar ridge preservation procedures regarding volumetric changes assessed by cone beam computed tomography (CBCT).
- Conditions
- Alveolar Ridge Preservation
- Being tested
- Amniotic Chorion Membrane and Bio-Oss xenograft, Amniotic Chorion Membrane only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic Chorion Membrane and Bio-Oss xenograftOther
Bioxclude Amniotic Chorion Membrane with xenograft (Bio-Oss) for ridge preservation
Amniotic Chorion Membrane onlyOther
Bioxclude Amniotic Chorion Membrane only
| Study group | Role | What they receive |
|---|---|---|
| Amnoitic Chorion Membrane and xenograft | Experimental | extraction sockets where ridge preservation will be performed using Chorion Membrane with Xenograft Receives: Other: Amniotic Chorion Membrane and Bio-Oss xenograft |
| Amnoitic Chorion Membrane only | Active comparator | extraction sockets where ridge preservation will be performed using Chorion Membrane Alone Receives: Other: Amniotic Chorion Membrane only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bucco-lingual bone width
Bone width will be measured using bone caliper and radiographically
Measured: at baseline, 1 months and 4 months
Change in Corono-apical bone height
Bone height using a pre-fabricated stent.
Measured: at baseline, 1 months and 4 months
total bone volume change
It will be evaluated by the use of 3D scans of patient dental models
Measured: at baseline, and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Dec 2020
- Primary completion1 Mar 2022
- 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 Alveolar Ridge PreservationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824235
- Sponsor's protocol ID
- alveolar preservation
- Status last verified
- Jan 2025
- First submitted
- 20 Mar 2021
- Last updated
- 7 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Ridge Preservation Using Amniotic Chorion Membrane Alone or Combined With Xenograft (A Randomized Controlled Clinical Trial With Histological Evaluation)
- ClinicalTrials.gov ID
- NCT04824235
- Acronym / sponsor ID
- alveolar preservation
- Conditions
- Alveolar Ridge Preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 1 Apr 2021 (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 is to compare the amniotic chorion membrane (ACM) alone versus the amniotic chorion membrane combined with xenograft for their efficacy in alveolar ridge preservation procedures regarding volumetric changes assessed by cone beam computed tomography (CBCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amnoitic Chorion Membrane and xenograft | Experimental | Other: Amniotic Chorion Membrane and Bio-Oss xenograftextraction sockets where ridge preservation will be performed using Chorion Membrane with Xenograft |
| Amnoitic Chorion Membrane only | Active comparator | Other: Amniotic Chorion Membrane onlyextraction sockets where ridge preservation will be performed using Chorion Membrane Alone |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients require extraction of a non-restorable (premolar or anterior tooth) located in the maxillary arch and needs implant restoration.
- Type two sockets will be selected as revealed by Cone beam computed tomography(CBCT)
- Absence of any systemic disease or drugs that contraindicate oral surgery using Modified Cornell Medical Index
- Male and female within age range of 20-45 years.
Key exclusion criteria (5 listed)
- Smokers.
- Patients with poor oral hygiene or non-compliant patients who are not willing to perform oral hygiene measures.
- Pregnant and breast-feeding females.
- Patients with acute peri-apical infection or sinus tract.
- Vulnerable group of patients as handicapped patients, orphans,prisoners,etc
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 |
|---|---|---|
| Amniotic Chorion Membrane and Bio-Oss xenograftBioxclude Amniotic Chorion Membrane with xenograft (Bio-Oss) for ridge preservation | Other | Amnoitic Chorion Membrane and xenograft |
| Amniotic Chorion Membrane onlyBioxclude Amniotic Chorion Membrane only | Other | Amnoitic Chorion Membrane only |
Primary outcome
Change in Bucco-lingual bone width
Time frame: at baseline, 1 months and 4 months
Bone width will be measured using bone caliper and radiographically
Change in Corono-apical bone height
Time frame: at baseline, 1 months and 4 months
Bone height using a pre-fabricated stent.
total bone volume change
Time frame: at baseline, and 4 months
It will be evaluated by the use of 3D scans of patient dental models
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 7 Jan 2025.
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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 study testing Amniotic Chorion Membrane and Bio-Oss xenograft and Amniotic Chorion Membrane only in people with Alveolar Ridge Preservation, run by Hams Hamed Abdelrahman 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 5 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 7 Jan 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?
Change in Bucco-lingual bone width (time frame: at baseline, 1 months and 4 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?
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 7 Jan 2025; AzTrials last refreshed its copy on 30 Oct 2026.