Alveolar Bone LossDDGNCT04393714
Demineralized Dentin Graft With Hydrochloric Acid Versus Nitric Acid in Alveolar Ridge Preservation
A study testing Alveolar ridge preservation after extraction in people with Alveolar Bone Loss, run by Cairo University.
Trial summary
The reduction in alveolar bone dimensions is an inevitable outcome after tooth extraction due to the healing events that results in bone modeling/remodeling. Alveolar ridge preservation is a successful approach that aids in reducing these changes greatly. 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 after extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 31 Oct 2021
- 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 teeth
- medically healthy
- able to provide informed consent and attend follow-up period
Who cannot join
- pregnant
- smokers or alcoholic
- severe bone loss
About this study
Official title: Demineralized Dentin Graft With Hydrochloric Acid Versus Nitric Acid in Alveolar Ridge Preservation. Randomised Controlled Clinical Trial
The reduction in alveolar bone dimensions is an inevitable outcome after tooth extraction due to the healing events that results in bone modeling/remodeling. Alveolar ridge preservation is a successful approach that aids in reducing these changes greatly. Various techniques have been employed to achieve that outcome utilizing bone grafts and/or membrane. Dentin graft is a promising type that can overcome many of the limitations facing mainstream grafts. Autogenous source serve the advantage of providing graft with no cross-infection risk or immunogenicity. Moreover, the unique structure of dentin makes it suitable for osteoinduction and osteoconduction that yields favorite bone regeneration outcomes. Demineralization of dentin is essential to release trapped growth factors, expose collagen fibrils and enhance the grafts degradability and replacement by native tissues. Many acids have been investigated for the use in chairside preparation of the dentin graft and hence, clinicians are faced with different choices but little evidence regarding the acid which yield s better outcomes.
- Conditions
- Alveolar Bone Loss
- Being tested
- Alveolar ridge preservation after extraction
- 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 after extractionProcedure or surgery
atraumatic extraction followed by graft material insertion
| Study group | Role | What they receive |
|---|---|---|
| autogenous dentin graft treated with nitric acid | Experimental | Not described Receives: Procedure: Alveolar ridge preservation after extraction |
| autogenous dentin graft treated with hydrochloric acid | Active comparator | Not described Receives: Procedure: Alveolar ridge preservation after extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic bone changes
width and height losses (quantitative in mm)
Measured: 6 months
Secondary outcomes (2)
histological analysis
Histologic observations (qualitative) and histomorphometric measurements (quantitative in %)
Measured: 6 months
soft tissue healing
rate of wound epitheliallization
Measured: Biweekly for 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Oct 2020 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Oct 2021 (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
- Single group
- Model description
- Split-mouth prospective randomized clinical trial with 1:1 assignment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 8 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
- NCT04393714
- Sponsor's protocol ID
- ARP2020
- Acronym
- DDG
- Status last verified
- Jul 2020
- First submitted
- 14 May 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demineralized Dentin Graft With Hydrochloric Acid Versus Nitric Acid in Alveolar Ridge Preservation. Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04393714
- Acronym / sponsor ID
- DDG / ARP2020
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 19 May 2020 (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 reduction in alveolar bone dimensions is an inevitable outcome after tooth extraction due to the healing events that results in bone modeling/remodeling. Alveolar ridge preservation is a successful approach that aids in reducing these changes greatly. Various techniques have been employed to achieve that outcome utilizing bone grafts and/or membrane. Dentin graft is a promising type that can overcome many of the limitations facing mainstream grafts. Autogenous source serve the advantage of providing graft with no cross-infection risk or immunogenicity. Moreover, the unique structure of dentin makes it suitable for osteoinduction and osteoconduction that yields favorite bone regeneration outcomes. Demineralization of dentin is essential to release trapped growth factors, expose collagen fibrils and enhance the grafts degradability and replacement by native tissues. Many acids have been investigated for the use in chairside preparation of the dentin graft and hence, clinicians are faced with different choices but little evidence regarding the acid which yield s better outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth prospective randomized clinical trial with 1:1 assignment
| Arm | Type | Receives |
|---|---|---|
| autogenous dentin graft treated with nitric acid | Experimental | Procedure: Alveolar ridge preservation after extraction |
| autogenous dentin graft treated with hydrochloric acid | Active comparator | Procedure: Alveolar ridge preservation after extraction |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Non-restorable teeth
- medically healthy
- able to provide informed consent and attend follow-up period
Key exclusion criteria (3 listed)
- pregnant
- smokers or alcoholic
- severe bone loss
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 after extractionatraumatic extraction followed by graft material insertion | Procedure or surgery | autogenous dentin graft treated with hydrochloric acid, autogenous dentin graft treated with nitric acid |
Primary outcome
Radiographic bone changes
Time frame: 6 months
width and height losses (quantitative in mm)
2 secondary outcomes
histological analysis
Time frame: 6 months
soft tissue healing
Time frame: Biweekly for 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar ridge preservation after extraction in people with Alveolar Bone Loss, 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 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: status not confirmed, as of the sponsor's last update on 15 Jul 2020. 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?
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?
Radiographic bone 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 15 Jul 2020.