Alveolar Ridge PreservationARPNCT03447795
Alveolar Ridge Preservation Using Autogenous Tooth Graft Versus Autogenous Demineralized Dentin Graft.
A study testing Alveolar ridge preservation in people with Alveolar Ridge Preservation and Dentin Graft, run by Cairo University at 1 site in Egypt.
Trial summary
Alveolar bone resorption following tooth extraction is unavoidable. Graft placement following extraction is recommended when considering restorative procedures afterwards. The extracted tooth was considered a clinical waste. However, it is now seen as a convenient and available source for graft material. 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, Dentin Graft, Autogenous Tooth Bone Graft
- 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
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 1 Jun 2020
- 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
- Patients with non-restorable non-molar teeth
- Patients > 18 years old
- Motivated patients who are willing to continue the follow-up period
Who cannot join
- Compromised alveolar socket that is not contained to support graft material
- smokers and alcoholic patients.
- Patients with systemic conditions that may compromise hard tissue healing (i.e. poorly controlled diabetes, autoimmune diseases).
- Local infection at the site of extraction.
- Teeth with root canal filling.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alveolar Ridge Preservation Using Autogenous Tooth Graft Versus Autogenous Demineralized Dentin Graft. A Randomized Controlled Clinical Trial.
Alveolar bone resorption following tooth extraction is unavoidable. Graft placement following extraction is recommended when considering restorative procedures afterwards. The extracted tooth was considered a clinical waste. However, it is now seen as a convenient and available source for graft material. Different protocols are applied to process the extracted tooth for obtaining the graft material and investigations are needed to assess the protocol with the best outcome.
Read the detailed description
Autogenous graft is widely accepted as the gold standard for grafting procedures(Sakkas et al. 2017). And since the introduction of autogenous dentin graft for alveolar ridge preservation by Kim et al. clinically (Y.-K. Kim et al. 2010), it has increasingly attracted attention and teeth are no longer seen only as a waste. Tooth dentin has a chemical composition similar to that of alveolar bone; the inorganic content is 70%-75%, organic content 20%, and water content 10%, whereas alveolar bone has proportions of 65%, 25%, and 10% respectively(Y.-K. Kim et al. 2013). The similarity in chemical composition between dentin and alveolar bone, as well as its content of growth factors such as bone morphogenetic proteins (BMPs), made the dentin a successful graft for filing alveolar bone defects of same patient(Y.-K. Kim et al. 2010, Nampo et al. 2010, Y.-K. Kim et al. 2013) .
The technique proposed by Kim et al includes demineralization of the dentin as it reduces minerals content, exposes collagen fibrils and increases BMPs released thus promoting the process of osteogenesis(Y.-K. Kim et al. 2010). However, demineralisation step is time-consuming, taking several days, which challenges same visit application. As a result, two main approaches have been developed to overcome this obstacle. One approach is to maintain the demineralization step but with improving the technique to shorten the processing time(MURATA et al. 2010, E.-S. Kim 2015, Kabir et al. 2015). On the other hand, many investigators have used the whole tooth without demineralization and reported satisfactory clinical outcome(Gideon Hallel et al. 2014, Valdec et al. 2017). Hence, more investigations are needed to evaluate the technique with the best outcome.
- 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
Also called ARP
grafting procedure using autogenous tooth.
| Study group | Role | What they receive |
|---|---|---|
| autogenous tooth grafted sites | Experimental | Not described Receives: Procedure: Alveolar ridge preservation |
| autogenous demineralised dentin grafted sites | Active comparator | Not described Receives: Procedure: Alveolar ridge preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cone beam computed tomography (CBCT) analysis
CBCT scans will be taken at first day and at 6 months after the grafting procedures. The scans will be compared using predetermined reference points, buccolingual and vertical dimensions will be measured in cross-sectional images using the same reference points and lines. The difference in mm will be subtracted.
Measured: immediately and after 6 months of grafting
Secondary outcomes (1)
Histological analysis
Bone samples from at least one control and one intervention site will be taken during implant placement. Patients will be asked to sign and additional informed consent. A trephine bur will be used to obtain samples and then sent to the department of oral histology for assessment
Measured: after 6 months of grafting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Feb 2019
- Primary completion1 Mar 2020
- Study completion1 Jun 2020
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
- Model description
- Randomized controlled clinical trial (RCT) with parallel group, two arm, with 1:1 allocation ratio.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
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
- NCT03447795
- Sponsor's protocol ID
- 19|01|02
- Acronym
- ARP
- Status last verified
- Nov 2020
- First submitted
- 15 Feb 2018
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Ridge Preservation Using Autogenous Tooth Graft Versus Autogenous Demineralized Dentin Graft. A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03447795
- Acronym / sponsor ID
- ARP / 19|01|02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 27 Feb 2018 (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.
Alveolar bone resorption following tooth extraction is unavoidable. Graft placement following extraction is recommended when considering restorative procedures afterwards. The extracted tooth was considered a clinical waste. However, it is now seen as a convenient and available source for graft material. Different protocols are applied to process the extracted tooth for obtaining the graft material and investigations are needed to assess the protocol with the best outcome.
Detailed description
Autogenous graft is widely accepted as the gold standard for grafting procedures(Sakkas et al. 2017). And since the introduction of autogenous dentin graft for alveolar ridge preservation by Kim et al. clinically (Y.-K. Kim et al. 2010), it has increasingly attracted attention and teeth are no longer seen only as a waste. Tooth dentin has a chemical composition similar to that of alveolar bone; the inorganic content is 70%-75%, organic content 20%, and water content 10%, whereas alveolar bone has proportions of 65%, 25%, and 10% respectively(Y.-K. Kim et al. 2013). The similarity in chemical composition between dentin and alveolar bone, as well as its content of growth factors such as bone morphogenetic proteins (BMPs), made the dentin a successful graft for filing alveolar bone defects of same patient(Y.-K. Kim et al. 2010, Nampo et al. 2010, Y.-K. Kim et al. 2013) .
The technique proposed by Kim et al includes demineralization of the dentin as it reduces minerals content, exposes collagen fibrils and increases BMPs released thus promoting the process of osteogenesis(Y.-K. Kim et al. 2010). However, demineralisation step is time-consuming, taking several days, which challenges same visit application. As a result, two main approaches have been developed to overcome this obstacle. One approach is to maintain the demineralization step but with improving the technique to shorten the processing time(MURATA et al. 2010, E.-S. Kim 2015, Kabir et al. 2015). On the other hand, many investigators have used the whole tooth without demineralization and reported satisfactory clinical outcome(Gideon Hallel et al. 2014, Valdec et al. 2017). Hence, more investigations are needed to evaluate the technique with the best outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial (RCT) with parallel group, two arm, with 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| autogenous tooth grafted sites | Experimental | Procedure: Alveolar ridge preservation |
| autogenous demineralised dentin grafted sites | Active comparator | Procedure: Alveolar ridge preservation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with non-restorable non-molar teeth
- Patients > 18 years old
- Motivated patients who are willing to continue the follow-up period
Key exclusion criteria (5 listed)
- Compromised alveolar socket that is not contained to support graft material
- smokers and alcoholic patients.
- Patients with systemic conditions that may compromise hard tissue healing (i.e. poorly controlled diabetes, autoimmune diseases).
- Local infection at the site of extraction.
- Teeth with root canal filling.
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 preservationAlso: ARPgrafting procedure using autogenous tooth. | Procedure or surgery | autogenous demineralised dentin grafted sites, autogenous tooth grafted sites |
Primary outcome
Cone beam computed tomography (CBCT) analysis
Time frame: immediately and after 6 months of grafting
CBCT scans will be taken at first day and at 6 months after the grafting procedures. The scans will be compared using predetermined reference points, buccolingual and vertical dimensions will be measured in cross-sectional images using the same reference points and lines. The difference in mm will be subtracted.
1 secondary outcome
Histological analysis
Time frame: after 6 months of grafting
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 10 Nov 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Alveolar Ridge Preservation and Dentin Graft, 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: finished, as of the sponsor's last update on 10 Nov 2020. 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?
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?
Cone beam computed tomography (CBCT) analysis (time frame: immediately and after 6 months of grafting). 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 10 Nov 2020.