Alveolar Ridge PreservationNCT05683509
Alveolar Ridge Preservation With Layered Collagen and Xenograft
A study testing deep collagen layer, xenograft and collagen membrane and xenograft and collagen membrane in people with Alveolar Ridge Preservation, run by Ain Shams University at 1 site in Egypt.
Trial summary
alveolar ridge preservation using deep collagen layer, xenograft and collagen membrane seal versus the use of xenograft and collagen membrane seal alone. Measuring the clinical and radiographic alveolar ridge dimensional changes following after preservation at the time of implant placement Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Preservation
- What is being tested?
- deep collagen layer, xenograft and collagen membrane and xenograft and collagen membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2022to 1 Sep 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy patients (American Society of Anesthesiologists I; ASA I).
- Patients diagnosed with single unrestorable molar teeth (socket type I) requiring extraction and implant placement (Elian et al.2007).
- Teeth free from any infection or periapical pathosis.
- Enough zone of keratinized tissue with at least 2mm.
- Good compliance with the plaque control instructions following initial therapy.
- Availability for follow up and maintenance program.
Who cannot join
- Bad oral hygiene.
- Presence of smoking habit.
- Presence of occlusal interferences
- Pregnant females
- Vulnerable group of patients (handicapped, mentally retarded and prisoners) (according to the recommendation of esthetical committee of Faculty of Dentistry Ain Shams University).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry Ain Shams University
Cairo, Cairo Governorate, 4393005
About this study
Official title: Biologically Oriented Alveolar Ridge Preservation With Layered Collagen and Xenograft (A Randomized Controlled Clinical Trial With Histological Evaluation)
alveolar ridge preservation using deep collagen layer, xenograft and collagen membrane seal versus the use of xenograft and collagen membrane seal alone. Measuring the clinical and radiographic alveolar ridge dimensional changes following after preservation at the time of implant placement
Read the detailed description
alveolar ridge preservation using deep collagen layer, xenograft and collagen membrane seal versus the use of xenograft and collagen membrane seal alone.
The primary objective of the study is measuring the clinical and radiographic alveolar ridge dimensional changes following the procedure 4 months post operatively
The secondary objective :
- Histological assessment of alveolar bone specimens to assess bone remodeling and new bone formation in both studied groups after four months.
- Patient satisfaction after implant placement
- Conditions
- Alveolar Ridge Preservation
- Being tested
- deep collagen layer, xenograft and collagen membrane, xenograft and collagen membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep collagen layer, xenograft and collagen membraneProcedure or surgery
Alveolar ridge preservation is done using deep collagen layer, xenograft and collagen membrane
xenograft and collagen membraneProcedure or surgery
Alveolar ridge preservation is done using xenograft and collagen membrane only
| Study group | Role | What they receive |
|---|---|---|
| deep collagen layer, xenograft and collagen membrane | Active comparator | Alveolar ridge preservation is done using deep collagen layer, xenograft and collagen membrane Receives: Procedure: deep collagen layer, xenograft and collagen membrane |
| xenograft and collagen membrane | Active comparator | Alveolar ridge preservation is done using xenograft and collagen membrane alone Receives: Procedure: xenograft and collagen membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the clinical alveolar ridge changes
Measuring the thickness of the alveolar ridge in mm
Measured: at baseline and 4 months
Measuring the radiographic change in the buccal bone thickness
Measuring the change in the thickness of the buccal ridge radiographically in mm
Measured: at baseline and 4 months
Measuring the radiographic alveolar ridge dimensional changes
Measuring the bone density in hounsfield units (HU)
Measured: at baseline and 4 months
Secondary outcomes (1)
Histological assessment of core biopsy
The microscopic examination of the bone remodeling and new bone through tissue biopsy (fixation and staining of the tissues) to examine the newly formed cells and count them to determine the amount of newly tissue formed
Measured: 4 months post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start30 May 2022
- Primary completion30 Apr 2023
- Study completion1 Sep 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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The application of deep collagen layer, xenograft and collagen membrane seal versus the use of xenograft and collagen membrane seal alone in alveolar ridge preservation procedures.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hala Abu el ela, Prof, Study chair, Faculty of dentistry ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683509
- Sponsor's protocol ID
- PHD-992
- Status last verified
- Jan 2023
- First submitted
- 12 Dec 2022
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biologically Oriented Alveolar Ridge Preservation With Layered Collagen and Xenograft (A Randomized Controlled Clinical Trial With Histological Evaluation)
- ClinicalTrials.gov ID
- NCT05683509
- Acronym / sponsor ID
- PHD-992
- Conditions
- Alveolar Ridge Preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 13 Jan 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.
alveolar ridge preservation using deep collagen layer, xenograft and collagen membrane seal versus the use of xenograft and collagen membrane seal alone. Measuring the clinical and radiographic alveolar ridge dimensional changes following after preservation at the time of implant placement
Detailed description
alveolar ridge preservation using deep collagen layer, xenograft and collagen membrane seal versus the use of xenograft and collagen membrane seal alone.
The primary objective of the study is measuring the clinical and radiographic alveolar ridge dimensional changes following the procedure 4 months post operatively
The secondary objective :
- Histological assessment of alveolar bone specimens to assess bone remodeling and new bone formation in both studied groups after four months.
- Patient satisfaction after implant placement
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The application of deep collagen layer, xenograft and collagen membrane seal versus the use of xenograft and collagen membrane seal alone in alveolar ridge preservation procedures.
| Arm | Type | Receives |
|---|---|---|
| deep collagen layer, xenograft and collagen membrane | Active comparator | Procedure: deep collagen layer, xenograft and collagen membraneAlveolar ridge preservation is done using deep collagen layer, xenograft and collagen membrane |
| xenograft and collagen membrane | Active comparator | Procedure: xenograft and collagen membraneAlveolar ridge preservation is done using xenograft and collagen membrane alone |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Systemically healthy patients (American Society of Anesthesiologists I; ASA I).
- Teeth free from any infection or periapical pathosis.
- Enough zone of keratinized tissue with at least 2mm.
- Good compliance with the plaque control instructions following initial therapy.
- Availability for follow up and maintenance program.
Key exclusion criteria (5 listed)
- Bad oral hygiene.
- Presence of smoking habit.
- Presence of occlusal interferences
- Pregnant females
- Vulnerable group of patients (handicapped, mentally retarded and prisoners) (according to the recommendation of esthetical committee of Faculty of Dentistry Ain Shams University).
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 |
|---|---|---|
| deep collagen layer, xenograft and collagen membraneAlveolar ridge preservation is done using deep collagen layer, xenograft and collagen membrane | Procedure or surgery | deep collagen layer, xenograft and collagen membrane |
| xenograft and collagen membraneAlveolar ridge preservation is done using xenograft and collagen membrane only | Procedure or surgery | xenograft and collagen membrane |
Primary outcome
Measuring the clinical alveolar ridge changes
Time frame: at baseline and 4 months
Measuring the thickness of the alveolar ridge in mm
Measuring the radiographic change in the buccal bone thickness
Time frame: at baseline and 4 months
Measuring the change in the thickness of the buccal ridge radiographically in mm
Measuring the radiographic alveolar ridge dimensional changes
Time frame: at baseline and 4 months
Measuring the bone density in hounsfield units (HU)
1 secondary outcome
Histological assessment of core biopsy
Time frame: 4 months post operatively
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 24 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Hala Abu el ela, Prof study chair
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 study testing deep collagen layer, xenograft and collagen membrane and xenograft and collagen membrane in people with Alveolar Ridge Preservation, 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 6 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 24 Feb 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?
Measuring the clinical alveolar ridge changes (time frame: at baseline 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 24 Feb 2025.