Alveolar Ridge EnlargementPhase 3NCT05812872
Alveolar Ridge Preservation Using Different Bone Substitutes
A Phase 3 study testing Toothgraft, Allograft and Alloplast in people with Alveolar Ridge Enlargement, run by Ain Shams University at 1 site in Egypt.
Trial summary
The primary objective of this study was to compare the efficacy of using allograft, autogenous tooth graft, and beta-tricalcium phosphate for alveolar ridge preservation (ARP) by examining the alveolar ridge height and width at baseline and 3 months after the ARP both clinically and radiographically. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Enlargement
- What is being tested?
- Toothgraft, Allograft and Alloplast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2017to 20 Jan 2019
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- seeking implant-based restorations after tooth extraction.
- exhibited no evidence of any significant medical history, measured using Burket's Oral medicine health history questionnaire.
- exhibited Type I and II sockets
Who cannot join
- nonsmokers.
- Pregnant and breast-feeding females
- patients with known contraindications to dental implant surgery (e.g., increased bleeding tendency, history of treatments such as radiotherapy,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Allograft, Toothgraft, Alloplast on Alveolar Ridge Preservation
The primary objective of this study was to compare the efficacy of using allograft, autogenous tooth graft, and beta-tricalcium phosphate for alveolar ridge preservation (ARP) by examining the alveolar ridge height and width at baseline and 3 months after the ARP both clinically and radiographically. The secondary objective was to evaluate the quality of the newly formed bone using histomorphometric analysis.
Read the detailed description
This randomized controlled clinical trial included thirty patients. ARP was performed using either Allograft (Allograft group n=10), Tooth graft (Toothgraft group n=10), and beta tri-calcium- phosphate (beta tri-calcium group n=10). Changes in alveolar ridge dimensions were evaluated clinically and radiographically using cone beam computed tomography at baseline and 3 months. Core bone biopsy samples were obtained 3 months post-extraction during implant placement for histomorphometric analysis.
- Conditions
- Alveolar Ridge Enlargement
- Being tested
- Toothgraft, Allograft, Alloplast
- Keywords
- Alveolar ridge preservation, Allograft, Toothgraft, Allopast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToothgraftDrug
Particulate dentin
AllograftDrug
Also called Mineralized corticocancellous allograft
Mineralized corticocancellous allograft
AlloplastDrug
Also called Beta tri-calcuim phosphate
Beta tri-calcuim phosphate
| Study group | Role | What they receive |
|---|---|---|
| Alveolar ridge preservationwith tooth graft | Active comparator | tooth graft Receives: Drug: Toothgraft |
| Alveolar ridge preservation with allograft | Active comparator | Allograft Receives: Drug: Allograft |
| Alveolar ridge preservation with alloplast | Active comparator | Beta Tri-Calcium phosphate Receives: Drug: Alloplast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment
Measure bone height loss in millimeter at baseline and after 3 months was measured using periodontal probe from the stent margin to the alveolar ridge crest at six points. In addition, Bone width loss was calculated by measuring alveolar ridge width buccopalatally in millimeter using a caliper clamp. The measurement was done perpendicular to the tangent of the dental arch at the mid-point of the extraction site approximately 4mm apical to the level of the marginal gingiva of the adjacent teeth.
Measured: 3 months
Clinical assessment
Bone width loss was calculated by measuring alveolar ridge width buccopalatally in millimeter using a caliper clamp. The measurement was done perpendicular to the tangent of the dental arch at the mid-point of the extraction site approximately 4mm apical to the level of the marginal gingiva of the adjacent teeth.
Measured: 3 months
Secondary outcomes (2)
Radiographic assessment
Measuring loss in bone height in millimeters between baseline and after 3 months. Loss in bone height was calculated by measuring the distance from the alveolar crest both buccally and palatally to a fixed anatomical landmark. In addition,
Measured: 3 months
Radiographic assessment
Loss in bone width was calculated by measuring distance from buccal alveolar crest to palatal alveolar crest in millimeter.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start20 Jun 2017
- Primary completion23 Sep 2018
- Study completion20 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge EnlargementStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yasmine A Fouad, Ph.D, Principal investigator, Ain Shams UniversitySuzan M Sarhan, Ph.D, Study director, Ain Shams UniversityHadeel M Gamal, Ph.D, Study director, Ain Shams UniversityBasma A Abdelrahman, Ph.D, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812872
- Sponsor's protocol ID
- FDASU-RecIR092210
- Status last verified
- Mar 2023
- First submitted
- 4 Sep 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Allograft, Toothgraft, Alloplast on Alveolar Ridge Preservation
- ClinicalTrials.gov ID
- NCT05812872
- Acronym / sponsor ID
- FDASU-RecIR092210
- Conditions
- Alveolar Ridge Enlargement
- Keywords
- Alveolar ridge preservation, Allograft, Toothgraft, Allopast
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 23 Sep 2018 (actual)
- Study completion
- 20 Jan 2019 (actual)
- First posted
- 14 Apr 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.
The primary objective of this study was to compare the efficacy of using allograft, autogenous tooth graft, and beta-tricalcium phosphate for alveolar ridge preservation (ARP) by examining the alveolar ridge height and width at baseline and 3 months after the ARP both clinically and radiographically. The secondary objective was to evaluate the quality of the newly formed bone using histomorphometric analysis.
Detailed description
This randomized controlled clinical trial included thirty patients. ARP was performed using either Allograft (Allograft group n=10), Tooth graft (Toothgraft group n=10), and beta tri-calcium- phosphate (beta tri-calcium group n=10). Changes in alveolar ridge dimensions were evaluated clinically and radiographically using cone beam computed tomography at baseline and 3 months. Core bone biopsy samples were obtained 3 months post-extraction during implant placement for histomorphometric analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alveolar ridge preservationwith tooth graft | Active comparator | Drug: Toothgrafttooth graft |
| Alveolar ridge preservation with allograft | Active comparator | Drug: AllograftAllograft |
| Alveolar ridge preservation with alloplast | Active comparator | Drug: AlloplastBeta Tri-Calcium phosphate |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- seeking implant-based restorations after tooth extraction.
- exhibited no evidence of any significant medical history, measured using Burket's Oral medicine health history questionnaire.
- exhibited Type I and II sockets
Key exclusion criteria (3 listed)
- nonsmokers.
- Pregnant and breast-feeding females
- patients with known contraindications to dental implant surgery (e.g., increased bleeding tendency, history of treatments such as radiotherapy,
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 |
|---|---|---|
| ToothgraftParticulate dentin | Drug | Alveolar ridge preservationwith tooth graft |
| AllograftAlso: Mineralized corticocancellous allograftMineralized corticocancellous allograft | Drug | Alveolar ridge preservation with allograft |
| AlloplastAlso: Beta tri-calcuim phosphateBeta tri-calcuim phosphate | Drug | Alveolar ridge preservation with alloplast |
Primary outcome
Clinical assessment
Time frame: 3 months
Measure bone height loss in millimeter at baseline and after 3 months was measured using periodontal probe from the stent margin to the alveolar ridge crest at six points. In addition, Bone width loss was calculated by measuring alveolar ridge width buccopalatally in millimeter using a caliper clamp. The measurement was done perpendicular to the tangent of the dental arch at the mid-point of the extraction site approximately 4mm apical to the level of the marginal gingiva of the adjacent teeth.
Clinical assessment
Time frame: 3 months
Bone width loss was calculated by measuring alveolar ridge width buccopalatally in millimeter using a caliper clamp. The measurement was done perpendicular to the tangent of the dental arch at the mid-point of the extraction site approximately 4mm apical to the level of the marginal gingiva of the adjacent teeth.
2 secondary outcomes
Radiographic assessment
Time frame: 3 months
Radiographic assessment
Time frame: 3 months
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 19 Apr 2023.
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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.
Yasmine A Fouad, Ph.D principal investigator
Ain Shams University
Suzan M Sarhan, Ph.D study director
Ain Shams University
Hadeel M Gamal, Ph.D study director
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 Phase 3 study testing Toothgraft, Allograft and Alloplast in people with Alveolar Ridge Enlargement, 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 3 inclusion and 3 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 19 Apr 2023. 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?
Clinical assessment (time frame: 3 months). 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 19 Apr 2023.