Alveolar Bone LossNCT05336149
Demineralized Whole-tooth vs Demineralized Particulate Dentin Grafts in Alveolar Ridge Preservation
A study testing Alveolar ridge preservation using whole-tooth dentin graft and Alveolar ridge preservation using particulate dentin graft in people with Alveolar Bone Loss, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this trial is to compare whole-tooth vs particulate dentin for their effects in alveolar ridge preservation. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Alveolar ridge preservation using whole-tooth dentin graft and Alveolar ridge preservation using particulate dentin graft
- 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
- Jun 2022to Jun 2023
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-restorable tooth indicated for extraction
- single-rooted teeth
- Patients at least 18 years or older
- Motivated patients, agree to sign informed consent and complete the follow-up period
Who cannot join
- Pregnant females
- active infection at extraction site
- Smokers
- systemic conditions affecting healing (e.g. diabetes, medications as bisphosphonates...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Demineralized Whole-tooth vs Demineralized Particulate Dentin Grafts in Alveolar Ridge Preservation. a Randomized Controlled Trial.
The aim of this trial is to compare whole-tooth vs particulate dentin for their effects in alveolar ridge preservation.
Read the detailed description
Extraction of the teeth is still one of the most commonly undertaken procedures in dental practices due to various reasons that render the teeth non-restorable. Following extraction, replacing the lost teeth with a prosthetic alternative that provides for both optimal esthetics and function can be challenging due to the inevitable events of socket healing that results in the reduction in alveolar bone height and width. To overcome these limitations and provide for adequate ridge volume, different bone preservation or augmentation techniques can be utilized with different clinical applications.
Alveolar ridge preservation is a procedure that attempts to reduce bone dimensional changes that naturally take place following tooth extraction. To overcome this problem, various approaches using various grafting materials and/or covering membranes have been proposed with varied success. The extracted tooth is no longer considered as clinical waste, it has been explored as an appropriate source for autogenous graft substitute. This idea emerged due to the shared embryonic origin of bone and teeth as well as the similarities in chemical structure as dentin is composed of 30-35% organic part and 65-70% inorganic part in comparison to alveolar bone, with inorganic and organic parts of 35% and 65% respectively. Both whole-tooth and particulate forms has been utilized for alveolar ridge preservation or augmentation but the superiority of one form over the other is not yet clear.
- Conditions
- Alveolar Bone Loss
- Being tested
- Alveolar ridge preservation using whole-tooth dentin graft, Alveolar ridge preservation using particulate dentin graft
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar ridge preservation using whole-tooth dentin graftProcedure or surgery
Minimally-traumatic extraction of non-restorable teeth then grafting with whole-tooth dentin graft
Alveolar ridge preservation using particulate dentin graftProcedure or surgery
Minimally-traumatic extraction of non-restorable teeth then grafting with particulate dentin graft
| Study group | Role | What they receive |
|---|---|---|
| Whole-tooth dentin graft | Experimental | The extracted tooth will be prepared as whole-tooth dentin graft and inserted in the extraction socket. Receives: Procedure: Alveolar ridge preservation using whole-tooth dentin graft |
| Particulate dentin graft | Active comparator | The extracted tooth will be prepared as particulate dentin graft and inserted in the extraction socket. Receives: Procedure: Alveolar ridge preservation using particulate dentin graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar bone width change in mm
Alveolar bone linear width will be measured at baseline at final cone beam computed tomography (CBCT) scans. The change in bone width will be calculated as the subtraction of final width from baseline width and will be expressed in millimetres.
Measured: 6 months
Secondary outcomes (2)
Alveolar bone height change in mm
Alveolar bone linear height will be measured at baseline at final cone beam computed tomography (CBCT) scans. The change in bone height will be calculated as the subtraction of final height from baseline height and will be expressed in millimetres.
Measured: 6 months
Histological assessment
Bone samples from at least one control and one intervention site will be taken during implant placement using a trephine bur. Samples will be examined for new bone formation (Yes/no) and inflammatory response (Yes/no).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study startJun 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed AbdelRaouf Hussein, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336149
- Sponsor's protocol ID
- 42022
- Status last verified
- Apr 2022
- First submitted
- 4 Apr 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demineralized Whole-tooth vs Demineralized Particulate Dentin Grafts in Alveolar Ridge Preservation. a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05336149
- Acronym / sponsor ID
- 42022
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 20 Apr 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.
The aim of this trial is to compare whole-tooth vs particulate dentin for their effects in alveolar ridge preservation.
Detailed description
Extraction of the teeth is still one of the most commonly undertaken procedures in dental practices due to various reasons that render the teeth non-restorable. Following extraction, replacing the lost teeth with a prosthetic alternative that provides for both optimal esthetics and function can be challenging due to the inevitable events of socket healing that results in the reduction in alveolar bone height and width. To overcome these limitations and provide for adequate ridge volume, different bone preservation or augmentation techniques can be utilized with different clinical applications.
Alveolar ridge preservation is a procedure that attempts to reduce bone dimensional changes that naturally take place following tooth extraction. To overcome this problem, various approaches using various grafting materials and/or covering membranes have been proposed with varied success. The extracted tooth is no longer considered as clinical waste, it has been explored as an appropriate source for autogenous graft substitute. This idea emerged due to the shared embryonic origin of bone and teeth as well as the similarities in chemical structure as dentin is composed of 30-35% organic part and 65-70% inorganic part in comparison to alveolar bone, with inorganic and organic parts of 35% and 65% respectively. Both whole-tooth and particulate forms has been utilized for alveolar ridge preservation or augmentation but the superiority of one form over the other is not yet clear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole-tooth dentin graft | Experimental | Procedure: Alveolar ridge preservation using whole-tooth dentin graftThe extracted tooth will be prepared as whole-tooth dentin graft and inserted in the extraction socket. |
| Particulate dentin graft | Active comparator | Procedure: Alveolar ridge preservation using particulate dentin graftThe extracted tooth will be prepared as particulate dentin graft and inserted in the extraction socket. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non-restorable tooth indicated for extraction
- single-rooted teeth
- Patients at least 18 years or older
- Motivated patients, agree to sign informed consent and complete the follow-up period
Key exclusion criteria (4 listed)
- Pregnant females
- active infection at extraction site
- Smokers
- systemic conditions affecting healing (e.g. diabetes, medications as bisphosphonates...)
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 |
|---|---|---|
| Alveolar ridge preservation using whole-tooth dentin graftMinimally-traumatic extraction of non-restorable teeth then grafting with whole-tooth dentin graft | Procedure or surgery | Whole-tooth dentin graft |
| Alveolar ridge preservation using particulate dentin graftMinimally-traumatic extraction of non-restorable teeth then grafting with particulate dentin graft | Procedure or surgery | Particulate dentin graft |
Primary outcome
Alveolar bone width change in mm
Time frame: 6 months
Alveolar bone linear width will be measured at baseline at final cone beam computed tomography (CBCT) scans. The change in bone width will be calculated as the subtraction of final width from baseline width and will be expressed in millimetres.
2 secondary outcomes
Alveolar bone height change in mm
Time frame: 6 months
Histological assessment
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar ridge preservation using whole-tooth dentin graft and Alveolar ridge preservation using particulate dentin graft in people with Alveolar Bone Loss, 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 4 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 20 Apr 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 Ahmed Elfana, MSc (+2223634965, ahmed.abdelraouf@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alveolar bone width change in mm (time frame: 6 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 20 Apr 2022.