Socket Preservation, Alveolar Ridge Deficiency, Alveolar Ridge PreservationNCT05766137
Comparison of The Post-Extraction Dimensional Alterations Following Ridge Preservation Using Autogenous Partially and Completely Demineralized Dentin Grafts Versus Autogenous Whole-tooth Graft
A study testing Alveolar ridge preservation in people with Socket Preservation, Alveolar Ridge Deficiency, Alveolar Ridge Preservation, run by Cairo University.
Trial summary
For alveolar ridge preservation after extraction of a non-restorable maxillary non-molar tooth, will the use of Autogenous partially or completely demineralized dentin grafts result in similar ridge dimensions compared to Autogenous whole-tooth graft? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Socket Preservation, Alveolar Ridge Deficiency, Alveolar Ridge Preservation
- What is being tested?
- Alveolar ridge preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-molar maxillary teeth indicated for extraction.
- Extraction sockets having no more than 50% of buccal alveolar bone loss were included.
- Patients at least 18 years or older
- Motivated patients, agree to sign informed consent and complete the follow-up period
Who cannot join
- Infection at the extraction site
- Smokers
- Patients undergoing or having history of radiotherapy, chemotherapy or bisphosphonate therapy.
- Systemic conditions that may compromise healing or bone metabolism (e.g., uncontrolled diabetes, hyperthyroidism).
- Females that are pregnant or are planning to get pregnant during the study course.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of The Post-Extraction Dimensional Alterations Following Ridge Preservation Using Autogenous Partially and Completely Demineralized Dentin Grafts Versus Autogenous Whole-tooth Graft: A Randomized Controlled Clinical Trial
For alveolar ridge preservation after extraction of a non-restorable maxillary non-molar tooth, will the use of Autogenous partially or completely demineralized dentin grafts result in similar ridge dimensions compared to Autogenous whole-tooth graft?
Read the detailed description
One inevitable consequence of tooth loss is alveolar ridge resorption, which is progressive, irreversible, chronic, and cumulative. For implant placement, adequate dimensions of the alveolar ride housing are essential for proper implant positioning to provide for both implant stability and esthetics. Various procedures have been developed to limit post-extraction dimensional alterations or to restore normal bone dimensions, among which is ridge preservation. Numerous materials have been introduced and compared, nevertheless the best option is yet to be determined. Autogenous bone remains the gold standard for bone grafting, however one cannot ignore its unavoidable drawbacks, with donor site morbidity and the need for additional surgery having the biggest impact, as well as the limited amount that can be harvested and the unpredictable resorption rate. Several other options have been introduced with the aim of overcoming these disadvantages.
promising results have been reported, and the use of autogenous tooth bone graft (ATBG) is gaining popularity, since this material has a structure that closely resembles bone, especially the dentin which is composed of similar inorganic and organic elements, and also has osteoinductive and osteoconductive capacity.
Some studies using mineralized dentin matrix have shown that the material possesses excellent biocompatibility but is less effective than bone derived products in bone formation. On the other hand, several basic animal studies have shown that completely demineralized dentin matrix to be not only biocompatible, but also osteo-inductive, similar to demineralized bone matrix. The degree of demineralization is critical for optimal dentin regeneration; the partially demineralized dentin matrix is thought to have optimal conditions for dentin regeneration. Partial demineralization results in the elimination of the major part of the mineral phase and immunogenic components while retaining a very low fraction of minerals (5-10 wt%), providing an osteoconductive and osteo-inductive scaffold containing several growth factors.
It is agreed upon that nowadays optimizing protocols of demineralization of dentin grafts is necessary for standardization and further studies are required to determine the most suitable conditions of demineralization and particle sizes of dentin grafts for clinical application in implant dentistry. Additionally, more research is required to investigate whether graft preparation in its simplest form is sufficient or whether enhancing the graft with demineralization will result in any clinical significance.
- Being tested
- Alveolar ridge preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar ridge preservationProcedure or surgery
Socket preservation
| Study group | Role | What they receive |
|---|---|---|
| Ridge preservation by filling the socket with autogenous partially demineralized dentin graft | Experimental | 2% HNO3 partial demineralization for 10 minutes Receives: Procedure: Alveolar ridge preservation |
| Ridge preservation by filling the socket with autogenous completely demineralized dentin graft | Experimental | 0.6N HCl for 30 minutes for complete demineralization Receives: Procedure: Alveolar ridge preservation |
| Ridge preservation by filling the socket with autogenous whole-tooth graft (AWTG). | Active comparator | After cleaning the tooth, it will be ground using bone mill and AWTG particles will be prepared by immersing tooth particles in basic ethanol for 10 min for disinfection , then washed twice in saline and dried using sterile gauze. Receives: Procedure: Alveolar ridge preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar ridge width and height changes
Difference in alveolar ridge width and height linear measurements in millimeters between baseline and final CBCT scans after 6 months
Measured: 6 months
Secondary outcomes (1)
Histological assessment
Visual observation of graft remodeling and new bone formation (descriptive measurement)
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 posted13 Mar 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Socket Preservation, Alveolar Ridge Deficiency, 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
- Model description
- Parallel-group with allocation ratio of 1:1:1
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Osama Abdelwahab Megahed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766137
- Sponsor's protocol ID
- DinaAbdelwahabPerio
- Status last verified
- Apr 2023
- First submitted
- 14 Feb 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Post-Extraction Dimensional Alterations Following Ridge Preservation Using Autogenous Partially and Completely Demineralized Dentin Grafts Versus Autogenous Whole-tooth Graft: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05766137
- Acronym / sponsor ID
- DinaAbdelwahabPerio
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 13 Mar 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.
For alveolar ridge preservation after extraction of a non-restorable maxillary non-molar tooth, will the use of Autogenous partially or completely demineralized dentin grafts result in similar ridge dimensions compared to Autogenous whole-tooth graft?
Detailed description
One inevitable consequence of tooth loss is alveolar ridge resorption, which is progressive, irreversible, chronic, and cumulative. For implant placement, adequate dimensions of the alveolar ride housing are essential for proper implant positioning to provide for both implant stability and esthetics. Various procedures have been developed to limit post-extraction dimensional alterations or to restore normal bone dimensions, among which is ridge preservation. Numerous materials have been introduced and compared, nevertheless the best option is yet to be determined. Autogenous bone remains the gold standard for bone grafting, however one cannot ignore its unavoidable drawbacks, with donor site morbidity and the need for additional surgery having the biggest impact, as well as the limited amount that can be harvested and the unpredictable resorption rate. Several other options have been introduced with the aim of overcoming these disadvantages.
promising results have been reported, and the use of autogenous tooth bone graft (ATBG) is gaining popularity, since this material has a structure that closely resembles bone, especially the dentin which is composed of similar inorganic and organic elements, and also has osteoinductive and osteoconductive capacity.
Some studies using mineralized dentin matrix have shown that the material possesses excellent biocompatibility but is less effective than bone derived products in bone formation. On the other hand, several basic animal studies have shown that completely demineralized dentin matrix to be not only biocompatible, but also osteo-inductive, similar to demineralized bone matrix. The degree of demineralization is critical for optimal dentin regeneration; the partially demineralized dentin matrix is thought to have optimal conditions for dentin regeneration. Partial demineralization results in the elimination of the major part of the mineral phase and immunogenic components while retaining a very low fraction of minerals (5-10 wt%), providing an osteoconductive and osteo-inductive scaffold containing several growth factors.
It is agreed upon that nowadays optimizing protocols of demineralization of dentin grafts is necessary for standardization and further studies are required to determine the most suitable conditions of demineralization and particle sizes of dentin grafts for clinical application in implant dentistry. Additionally, more research is required to investigate whether graft preparation in its simplest form is sufficient or whether enhancing the graft with demineralization will result in any clinical significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel-group with allocation ratio of 1:1:1
| Arm | Type | Receives |
|---|---|---|
| Ridge preservation by filling the socket with autogenous partially demineralized dentin graft | Experimental | Procedure: Alveolar ridge preservation2% HNO3 partial demineralization for 10 minutes |
| Ridge preservation by filling the socket with autogenous completely demineralized dentin graft | Experimental | Procedure: Alveolar ridge preservation0.6N HCl for 30 minutes for complete demineralization |
| Ridge preservation by filling the socket with autogenous whole-tooth graft (AWTG). | Active comparator | Procedure: Alveolar ridge preservationAfter cleaning the tooth, it will be ground using bone mill and AWTG particles will be prepared by immersing tooth particles in basic ethanol for 10 min for disinfection , then washed twice in saline and dried using sterile gauze. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non-molar maxillary teeth indicated for extraction.
- Extraction sockets having no more than 50% of buccal alveolar bone loss were included.
- Patients at least 18 years or older
- Motivated patients, agree to sign informed consent and complete the follow-up period
Key exclusion criteria (5 listed)
- Infection at the extraction site
- Smokers
- Patients undergoing or having history of radiotherapy, chemotherapy or bisphosphonate therapy.
- Systemic conditions that may compromise healing or bone metabolism (e.g., uncontrolled diabetes, hyperthyroidism).
- Females that are pregnant or are planning to get pregnant during the study course.
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 preservationSocket preservation | Procedure or surgery | Ridge preservation by filling the socket with autogenous completely demineralized dentin graft, Ridge preservation by filling the socket with autogenous partially demineralized dentin graft, Ridge preservation by filling the socket with autogenous whole-tooth graft (AWTG). |
Primary outcome
Alveolar ridge width and height changes
Time frame: 6 months
Difference in alveolar ridge width and height linear measurements in millimeters between baseline and final CBCT scans after 6 months
1 secondary outcome
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 6 Apr 2023.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar ridge preservation in people with Socket Preservation, Alveolar Ridge Deficiency, Alveolar Ridge Preservation, run by Cairo University.
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: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Dina Abdelwahab, M.Sc. (0201003808409, dina.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?
Alveolar ridge width and height changes (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 6 Apr 2023.