Alveolar Ridge PreservationNCT05553548
Alveolar Ridge Changes With Biologically Oriented Alveolar Ridge Preservation (BARP) After Tooth Extraction
A study testing biologically oriented alveolar ridge preservation and xenogenic bone graft in entire (apico-coronal) extension in people with Alveolar Ridge Preservation, run by Cairo University at 1 site in Egypt.
Trial summary
After tooth extraction, the alveolar process undergoes substantial horizontal and vertical resorption specifically in non-molar sites, where horizontal, vertical mid- facial, and mid-lingual ridge reduction could occur . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Preservation
- What is being tested?
- biologically oriented alveolar ridge preservation and xenogenic bone graft in entire (apico-coronal) extension
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2022to 10 Jan 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18 years old or more.
- Patients with good oral hygiene, defined as a full-mouth plaque score ≤25% (O'Leary et al., 1972).
- Patients who need alveolar ridge preservation after tooth extraction at one or two sites in the aesthetic zone (incisor, cuspid, or premolar area in the maxilla or mandible) with >50% buccal bone present following tooth extraction (Eeckhout et al., 2022) .
- One or two neighboring teeth.
- Compliant patients who will sign an informed consent and agree to the follow up period.
Who cannot join
- • Uncontrolled systemic disease
- Past or current smoking
- Untreated or unstable periodontitis
- Untreated caries lesions.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo University
Cairo, Giza Governorate, 12613
nevein mohammed algammal, masters, 01126714444 ext. 002, nevein.osama@dentistry.cu.edu.eg
weam ahmed elbattawy, phd, 01001500537 ext. 002, weamelbattawy@dentistry.cu.edu.eg
About this study
Official title: Alveolar Ridge Changes With Biologically Oriented Alveolar Ridge Preservation (BARP) After Tooth Extraction : A Randomized Clinical Trial
After tooth extraction, the alveolar process undergoes substantial horizontal and vertical resorption specifically in non-molar sites, where horizontal, vertical mid- facial, and mid-lingual ridge reduction could occur . These dimensional changes are clinically relevant, as they may affect dental implant placement and compromise soft tissue aesthetics.
Alveolar ridge preservation (ARP) is based on the application of a bone replacement graft into the extraction socket \& collagen membrane/plug. Recent systematic reviews have shown that ARP may limit bone resorption to about 50% of what is normally observed in case of unassisted healing . This finding indicates that ARP is effective; but at the same time, it underlines the potential for improvement.
Read the detailed description
In ARP procedures based on socket grafting, the use of a bone replacement graft would prevent up to a 30% of volume reduction in the coronal third. Whereas it has limited effect in the remaining middle-apical thirds . Since grafting of the alveolus often results in the persistence of residual graft particles embedded into the newly formed bone with a delay in the rate of bone deposition and mineralization the need to extend the grafting procedure apical to the coronal third of the socket seems questionable. Based on these considerations, a novel, simplified technique, namely, the Biologically-oriented Alveolar Ridge Preservation (BARP) for ARP that restricts socket grafting to the coronal portion of the socket was presented .
- Conditions
- Alveolar Ridge Preservation
- Being tested
- biologically oriented alveolar ridge preservation, xenogenic bone graft in entire (apico-coronal) extension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biologically oriented alveolar ridge preservationProcedure or surgery
xenogenic bone graft placed in coronal part of the non molar socket ,, collagen plug placed in appical part of socket and as socket seal
xenogenic bone graft in entire (apico-coronal) extensionProcedure or surgery
xenogenic bone graft placed in the entire apico coronal extension and sealed with collagen plug
| Study group | Role | What they receive |
|---|---|---|
| biologically oriented alveolar ridge preservation (BARP) group | Experimental | for alveolar ridge preservation using demineralized bovine bone graft layer in the most coronal part of the extracted tooth socket Receives: Procedure: biologically oriented alveolar ridge preservation |
| bone graft (entire apico-coronal extension) | Active comparator | alveolar ridge preservation using demineralized bovine bone graft on the entire apico-coronal extension. Receives: Procedure: xenogenic bone graft in entire (apico-coronal) extension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal radiographic changes in bone dimensions
Horizontal measurements will be performed perpendicular and parallel to the tooth axis, respectively. The level of the palatal bone crest preoperatively will be used as a reference line (level 0). The horizontal dimension of the alveolar process will be registered at 1, 3, and 5 mm apical to this reference line (level 1, 3, and 5). After performing all measurements on the CBCT (T1), the software switched to the superimposed image (T4) so that the measurements could be performed while using the same reference levels. Finally, changes in bone dimensions will be calculated by subtracting bone dimensions at T4 from that at T1.
Measured: 4 months
Secondary outcomes (2)
Vertical radiographic changes in bone dimensions
Vertical measurement will be performed by measuring the height of buccal (B) and palatal (p) bone plates from the apical end of the socket to the coronal level of the socket.
Measured: 4 months
Changes of soft tissue height at the buccal , lingual & central aspects of the site.
Since soft tissues will be separated from hard tissues by using lip retractors and a backward position of the tongue, soft tissue height could be assessed on CBCT images. Changes in soft tissue height will be calculated by subtracting soft tissue height at T4 from that at T1
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start20 Oct 2022 (estimated)
- Primary completion5 Jan 2023 (estimated)
- Study completion10 Jan 2024 (estimated)
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 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevein Mohammed Osama Al-Gammal, Cairo University
- Investigators
- nevein mohmmeda algammal, master, Principal investigator, phd candidate (assistant lecturer)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553548
- Sponsor's protocol ID
- 8722
- Status last verified
- Sep 2022
- First submitted
- 18 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: name: nevein mohammed osama algammal email : nevein.osama@dentistry.cu.edu.eg
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Ridge Changes With Biologically Oriented Alveolar Ridge Preservation (BARP) After Tooth Extraction : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05553548
- Acronym / sponsor ID
- 8722
- Conditions
- Alveolar Ridge Preservation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Oct 2022 (estimated)
- Primary completion
- 5 Jan 2023 (estimated)
- Study completion
- 10 Jan 2024 (estimated)
- First posted
- 23 Sep 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.
After tooth extraction, the alveolar process undergoes substantial horizontal and vertical resorption specifically in non-molar sites, where horizontal, vertical mid- facial, and mid-lingual ridge reduction could occur . These dimensional changes are clinically relevant, as they may affect dental implant placement and compromise soft tissue aesthetics.
Alveolar ridge preservation (ARP) is based on the application of a bone replacement graft into the extraction socket \& collagen membrane/plug. Recent systematic reviews have shown that ARP may limit bone resorption to about 50% of what is normally observed in case of unassisted healing . This finding indicates that ARP is effective; but at the same time, it underlines the potential for improvement.
Detailed description
In ARP procedures based on socket grafting, the use of a bone replacement graft would prevent up to a 30% of volume reduction in the coronal third. Whereas it has limited effect in the remaining middle-apical thirds . Since grafting of the alveolus often results in the persistence of residual graft particles embedded into the newly formed bone with a delay in the rate of bone deposition and mineralization the need to extend the grafting procedure apical to the coronal third of the socket seems questionable. Based on these considerations, a novel, simplified technique, namely, the Biologically-oriented Alveolar Ridge Preservation (BARP) for ARP that restricts socket grafting to the coronal portion of the socket was presented .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biologically oriented alveolar ridge preservation (BARP) group | Experimental | Procedure: biologically oriented alveolar ridge preservationfor alveolar ridge preservation using demineralized bovine bone graft layer in the most coronal part of the extracted tooth socket |
| bone graft (entire apico-coronal extension) | Active comparator | Procedure: xenogenic bone graft in entire (apico-coronal) extensionalveolar ridge preservation using demineralized bovine bone graft on the entire apico-coronal extension. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults 18 years old or more.
- Patients with good oral hygiene, defined as a full-mouth plaque score ≤25% (O'Leary et al., 1972).
- Patients who need alveolar ridge preservation after tooth extraction at one or two sites in the aesthetic zone (incisor, cuspid, or premolar area in the maxilla or mandible) with >50% buccal bone present following tooth extraction (Eeckhout et al., 2022) .
- One or two neighboring teeth.
- Compliant patients who will sign an informed consent and agree to the follow up period.
Key exclusion criteria (4 listed)
- • Uncontrolled systemic disease
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 |
|---|---|---|
| biologically oriented alveolar ridge preservationxenogenic bone graft placed in coronal part of the non molar socket ,, collagen plug placed in appical part of socket and as socket seal | Procedure or surgery | biologically oriented alveolar ridge preservation (BARP) group |
| xenogenic bone graft in entire (apico-coronal) extensionxenogenic bone graft placed in the entire apico coronal extension and sealed with collagen plug | Procedure or surgery | bone graft (entire apico-coronal extension) |
Primary outcome
Horizontal radiographic changes in bone dimensions
Time frame: 4 months
Horizontal measurements will be performed perpendicular and parallel to the tooth axis, respectively. The level of the palatal bone crest preoperatively will be used as a reference line (level 0). The horizontal dimension of the alveolar process will be registered at 1, 3, and 5 mm apical to this reference line (level 1, 3, and 5). After performing all measurements on the CBCT (T1), the software switched to the superimposed image (T4) so that the measurements could be performed while using the same reference levels. Finally, changes in bone dimensions will be calculated by subtracting bone dimensions at T4 from that at T1.
2 secondary outcomes
Vertical radiographic changes in bone dimensions
Time frame: 4 months
Changes of soft tissue height at the buccal , lingual & central aspects of the site.
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Individual participant dataSharing planned: Yes. name: nevein mohammed osama algammal email : nevein.osama@dentistry.cu.edu.eg
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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.
nevein mohmmeda algammal, master principal investigator
phd candidate (assistant lecturer)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biologically oriented alveolar ridge preservation and xenogenic bone graft in entire (apico-coronal) extension in people with Alveolar Ridge 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nevein mohammed algammal, master (01126714444 ext. 002, nevein.osama@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal radiographic changes in bone dimensions (time frame: 4 months). 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 23 Sep 2022; AzTrials last refreshed its copy on 1 Nov 2026.