Alveolar Bone LossNCT05536479
Evaluation of Autogenous Stored Versus Autogenous Fresh Mineralized Dentin Graft for Alveolar Ridge Preservation
A study testing Autogenous stored mineralized dentin graft (ASMDG) and Autogenous fresh mineralized dentin graft (AFMDG) in people with Alveolar Bone Loss, run by Cairo University at 1 site in Egypt.
Trial summary
Tooth extraction triggers a cascade of biological events mediated by both the local inflammatory response that follows the surgical intervention and the deprivation of masticatory stimulation of the periodontium, which elicit an alteration of the homoeostasis and structural integrity of the periodontal tissues. 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?
- Autogenous stored mineralized dentin graft (ASMDG) and Autogenous fresh mineralized dentin graft (AFMDG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2022to Sep 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
- Potential candidates requiring extraction of maxillary non-molar teeth.
- Periodontally healthy adjacent teeth.
- Extraction sockets having no more than 50% of buccal alveolar bone loss
Who cannot join
- Smokers.
- Patients reporting systemic conditions that may compromise healing or bone metabolism (e.g., uncontrolled diabetes, hyperthyroidism).
- Patients having a history of radiotherapy, chemotherapy, or bisphosphonate therapy.
- Females who were pregnant or planning to get pregnant during the study course.
- Root canal treated teeth and teeth with acute infection at the site of extraction
Trial locations and contacts
1 site in 1 country.
Cairo University contact
About this study
Official title: Clinical, Radiographic and Histomorphometric Evaluation of Autogenous Stored Versus Autogenous Fresh Mineralized Dentin Graft for Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial
Tooth extraction triggers a cascade of biological events mediated by both the local inflammatory response that follows the surgical intervention and the deprivation of masticatory stimulation of the periodontium, which elicit an alteration of the homoeostasis and structural integrity of the periodontal tissues. Bone remodeling kicks off after tooth loss and continues for several months with most changes taking place in the first three months.
Interestingly, Schmidt-Schultz and Schultz, found that intact growth factors are conserved even in the collagenous extracellular matrix of ancient human bone and teeth. Thus, the application of stored dentin may have similar benefits as fresh dentin, preserving intact growth factors for a prolonged period avoiding the need to perform multiple surgical interventions simultaneously. The volume of the particulate dentin is more than twice of the original root volume. Thus, the idea of using autogenous stored mineralized dentin grafts (ASMDG) in ARP evolved.
Read the detailed description
Immediately following tooth extraction, the alveolar ridge comes across its normal physiologic healing process that results in respective alveolar bone loss, structural and compositional changes of the covering soft tissues, as well as morphological alterations.
In an attempt to cutback horizontal and vertical ridge losses, various techniques have been successfully proven to preserve the alveolar ridge including autografts, allografts, xenografts, alloplasts and autogenous dentin grafts. However, fresh autogenous bone graft is still considered gold standard since it exhibits bioactive cell instructive matrix properties and is non-immunogenic and non - pathogenic in spite of the need for harvesting bone and possible morbidity resulting from it. Nevertheless, no gold-standard technique is applicable for every clinical situation.
The similarities between dentin and alveolar bone may help the human body to show an acceptable biological behavior to dentin graft. It is therefore not surprising that dentin that comprises more than 85% of tooth structure can serve as a native bone grafting material, which is reflected by the interaction between mineralized dentin and osteogenic cells that attach and produce mineralized bone matrix directly on the dentin graft.
Mineralized dentin particles have the advantage to maintain its mechanical stability, allowing early loading after grafting in fresh sockets and bone defects where the mineralized dentin is firmly integrated with newly formed bone, creating a solid site for anchorage of dental implants.
Fresh ground dentin has been used successfully as a grafting material alternative in alveolar ridge preservation which has been manifested in that the clinically grafted sites demonstrated limited ridge resorption which allowed for subsequent implant placement without the need to use additional graft biomaterials.
- Conditions
- Alveolar Bone Loss
- Being tested
- Autogenous stored mineralized dentin graft (ASMDG), Autogenous fresh mineralized dentin graft (AFMDG)
- 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.
Autogenous stored mineralized dentin graft (ASMDG)Procedure or surgery
Autogenous stored mineralized dentin graft (ASMDG) 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.
The disinfected particles will then be stored at room temperature for 21 days in a sterile container. After 21 days, a second extraction will be performed followed by mixing the stored graft with a few drops of sterile saline to be packed in a socket after extraction
Autogenous fresh mineralized dentin graft (AFMDG)Procedure or surgery
Autogenous fresh mineralized dentin graft (AFMDG) 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.
| Study group | Role | What they receive |
|---|---|---|
| Autogenous stored mineralized dentin graft (ASMDG) | Experimental | Autogenous stored mineralized dentin graft (ASMDG) 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 The disinfected particles will then be stored at room temperature for 21 days in a sterile container. After 21 days, a second extraction will be performed followed by mixing the stored graft with a few drops of sterile saline to be packed in a socket after extraction Receives: Procedure: Autogenous stored mineralized dentin graft (ASMDG) |
| Autogenous fresh mineralized dentin graft (AFMDG) | Active comparator | Autogenous fresh mineralized dentin graft (AFMDG) 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: Autogenous fresh mineralized dentin graft (AFMDG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in buccolingual horizontal alveolar ridge width
The horizontal buccolingual alveolar ridge width will be measured radiographically on a CBCT at three levels: at -1 mm, -3 mm, -5 mm below the most coronal aspect of the crest (HW-1, HW-3, HW-5), and clinically by a caliper at -3 mm and -5 mm (HW-3 and HW-5). Measurements will be taken at baseline and after 4 months postoperatively to calculate the change.
Measured: 4 months
Secondary outcomes (2)
Alveolar buccal ridge height
The alveolar buccal ridge height will be measured radiographically on a CBCT at baseline and after 4 months postoperatively.
Measured: 4 months
Postoperative pain
Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable')
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Mohamed Wahsh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536479
- Sponsor's protocol ID
- ARPerio22
- Status last verified
- Sep 2022
- First submitted
- 8 Sep 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057.
PubMed 30623987Schmidt-Schultz TH, Schultz M. Intact growth factors are conserved in the extracellular matrix of ancient human bone and teeth: a storehouse for the study of human evolution in health and disease. Biol Chem. 2005 Aug;386(8):767-76. doi: 10.1515/BC.2005.090.
PubMed 16201872
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiographic and Histomorphometric Evaluation of Autogenous Stored Versus Autogenous Fresh Mineralized Dentin Graft for Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05536479
- Acronym / sponsor ID
- ARPerio22
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 10 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.
Tooth extraction triggers a cascade of biological events mediated by both the local inflammatory response that follows the surgical intervention and the deprivation of masticatory stimulation of the periodontium, which elicit an alteration of the homoeostasis and structural integrity of the periodontal tissues. Bone remodeling kicks off after tooth loss and continues for several months with most changes taking place in the first three months.
Interestingly, Schmidt-Schultz and Schultz, found that intact growth factors are conserved even in the collagenous extracellular matrix of ancient human bone and teeth. Thus, the application of stored dentin may have similar benefits as fresh dentin, preserving intact growth factors for a prolonged period avoiding the need to perform multiple surgical interventions simultaneously. The volume of the particulate dentin is more than twice of the original root volume. Thus, the idea of using autogenous stored mineralized dentin grafts (ASMDG) in ARP evolved.
Detailed description
Immediately following tooth extraction, the alveolar ridge comes across its normal physiologic healing process that results in respective alveolar bone loss, structural and compositional changes of the covering soft tissues, as well as morphological alterations.
In an attempt to cutback horizontal and vertical ridge losses, various techniques have been successfully proven to preserve the alveolar ridge including autografts, allografts, xenografts, alloplasts and autogenous dentin grafts. However, fresh autogenous bone graft is still considered gold standard since it exhibits bioactive cell instructive matrix properties and is non-immunogenic and non - pathogenic in spite of the need for harvesting bone and possible morbidity resulting from it. Nevertheless, no gold-standard technique is applicable for every clinical situation.
The similarities between dentin and alveolar bone may help the human body to show an acceptable biological behavior to dentin graft. It is therefore not surprising that dentin that comprises more than 85% of tooth structure can serve as a native bone grafting material, which is reflected by the interaction between mineralized dentin and osteogenic cells that attach and produce mineralized bone matrix directly on the dentin graft.
Mineralized dentin particles have the advantage to maintain its mechanical stability, allowing early loading after grafting in fresh sockets and bone defects where the mineralized dentin is firmly integrated with newly formed bone, creating a solid site for anchorage of dental implants.
Fresh ground dentin has been used successfully as a grafting material alternative in alveolar ridge preservation which has been manifested in that the clinically grafted sites demonstrated limited ridge resorption which allowed for subsequent implant placement without the need to use additional graft biomaterials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autogenous stored mineralized dentin graft (ASMDG) | Experimental | Procedure: Autogenous stored mineralized dentin graft (ASMDG)Autogenous stored mineralized dentin graft (ASMDG) 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 The disinfected particles will then be stored at room temperature for 21 days in a sterile container. After 21 days, a second extraction will be performed followed by mixing the stored graft with a few drops of sterile saline to be packed in a socket after extraction |
| Autogenous fresh mineralized dentin graft (AFMDG) | Active comparator | Procedure: Autogenous fresh mineralized dentin graft (AFMDG)Autogenous fresh mineralized dentin graft (AFMDG) 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 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Potential candidates requiring extraction of maxillary non-molar teeth.
- Periodontally healthy adjacent teeth.
- Extraction sockets having no more than 50% of buccal alveolar bone loss
Key exclusion criteria (5 listed)
- Smokers.
- Patients reporting systemic conditions that may compromise healing or bone metabolism (e.g., uncontrolled diabetes, hyperthyroidism).
- Patients having a history of radiotherapy, chemotherapy, or bisphosphonate therapy.
- Females who were pregnant or planning to get pregnant during the study course.
- Root canal treated teeth and teeth with acute infection at the site of extraction
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 |
|---|---|---|
| Autogenous stored mineralized dentin graft (ASMDG)Autogenous stored mineralized dentin graft (ASMDG) 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. The disinfected particles will then be stored at room temperature for 21 days in a sterile container. After 21 days, a second extraction will be performed followed by mixing the stored graft with a few drops of sterile saline to be packed in a socket after extraction | Procedure or surgery | Autogenous stored mineralized dentin graft (ASMDG) |
| Autogenous fresh mineralized dentin graft (AFMDG)Autogenous fresh mineralized dentin graft (AFMDG) 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. | Procedure or surgery | Autogenous fresh mineralized dentin graft (AFMDG) |
Primary outcome
Change in buccolingual horizontal alveolar ridge width
Time frame: 4 months
The horizontal buccolingual alveolar ridge width will be measured radiographically on a CBCT at three levels: at -1 mm, -3 mm, -5 mm below the most coronal aspect of the crest (HW-1, HW-3, HW-5), and clinically by a caliper at -3 mm and -5 mm (HW-3 and HW-5). Measurements will be taken at baseline and after 4 months postoperatively to calculate the change.
2 secondary outcomes
Alveolar buccal ridge height
Time frame: 4 months
Postoperative pain
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Background: PubMed 30623987Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057.
- Background: PubMed 16201872Schmidt-Schultz TH, Schultz M. Intact growth factors are conserved in the extracellular matrix of ancient human bone and teeth: a storehouse for the study of human evolution in health and disease. Biol Chem. 2005 Aug;386(8):767-76. doi: 10.1515/BC.2005.090.
- 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.
Cairo University contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autogenous stored mineralized dentin graft (ASMDG) and Autogenous fresh mineralized dentin graft (AFMDG) 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 3 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 10 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 Nada Wahsh, Bachelor (01026191091, nada.wahsh@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in buccolingual horizontal alveolar ridge width (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05536479, which also lists 2 linked publications.
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 10 Sep 2022.