Autogenous Dentin GraftNCT06609720
Randomized Clinical and Radiographic Study
A study testing (guided tissue regeneration) in people with Autogenous Dentin Graft, run by Tanta University at 1 site in Egypt.
Trial summary
Randomized clinical and radiographic trial Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Autogenous Dentin Graft
- What is being tested?
- (guided tissue regeneration)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 30 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 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- -
- Presence of class II and/or ΙΙΙ furcation defects in mandibular first or second molars according to criteria outlined by Hamp et. al. 1975.
- Horizontal probing depth ≥3 mm using Naber's probe.
- Clinical attachment level ≥3 mm measured from cemento-enamel junction (CEJ) till the deepest probing depth.
- Evidence of radiolucency in the furcation area on panoramic radiograph.
- Patients who will be assigned for groups (I and II) should present with teeth required for extraction due to advanced periodontal bone loss or other indications such as hopeless wisdom teeth or orthodontic indications or unrestorable fractured teeth as a source for autogenous dentin graft (ADG).
Who cannot join
- Medically compromised patients and systemic conditions precluding periodontal surgery.
- Mandibular first or second molars with root caries or endodontic treatment.
- Smokers, diabetics, pregnant or lactating women.
- History of chemotherapy, radiotherapy in head and/or neck region.
- Bisphosphonate therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Autogenous Dentin Graft Versus Demineralized Freeze-Dried Bone Allograft in the Treatment of Class ΙΙ and ΙΙΙ Mandibular Furcation Defects
Randomized clinical and radiographic trial
Read the detailed description
Evaluation of Autogenous Dentin Graft versus Demineralized Freeze-Dried Bone Allograft in the Treatment of Class ΙΙ and ΙΙΙ Mandibular Furcation Defects
- Conditions
- Autogenous Dentin Graft
- Being tested
- (guided tissue regeneration)
- Keywords
- dentin graft, tooth graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(guided tissue regeneration)Procedure or surgery
Randomized clinical and radiographic trial
| Study group | Role | What they receive |
|---|---|---|
| Group 1 subgroup A | Experimental | Grade II furcation involvement treated with autogenous dentin graft Receives: Procedure: (guided tissue regeneration) |
| Group 1 Subgroup B | Experimental | Grade II furcation involvement treated with demineralized freeze-dried bone allograft Receives: Procedure: (guided tissue regeneration) |
| Group II subgroup A | Experimental | Grade III furcation involvement treated with Autogenous dentin graft Receives: Procedure: (guided tissue regeneration) |
| Group II subgroup B | Experimental | Grade III furcation involvement treated with demineralized freeze-dried bone allograft Receives: Procedure: (guided tissue regeneration) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth
According to Ramfjord, clinical parameter measured by UNC periodontal probe from a fixed point to the deepest probing depth. Using stent to standardize the measurements.
Measured: Measured at baseline, 6 months and 12 months
Clinical attachment level
According to Ramfjord, clinical parameter measured by a Naber\'s probe. Using stent to standard measurements.
Measured: Measured at baseline, 6 months and 12 months
Bleeding on probing
According to Ramfjord, the bleeding at each site observed after probing and recorded positive if bleeding was observed within 30 seconds, if not was recorded as negative.
Measured: Measured at baseline, 6 months and 12 months
Secondary outcomes (1)
Radiographic outcome
Using CBCT software to analyse furcation volume
Measured: measured at baseline and 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Mar 2021
- Primary completion12 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autogenous Dentin GraftStudies of the same condition, open and under way.
- 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
- 2 groups with 2 subgroups, each subgroup receive either ADG or DFDBA
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Banan Lotfy Mohamed Amer, Tanta University
- Investigators
- Banan L Amer, Master, Principal investigator, Tanta UniversitySamia A Darwish, Professor, Study director, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609720
- Sponsor's protocol ID
- OMPDR
- Status last verified
- Feb 2021
- First submitted
- 5 Dec 2023
- Last updated
- 24 Sep 2024
- 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 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Autogenous Dentin Graft Versus Demineralized Freeze-Dried Bone Allograft in the Treatment of Class ΙΙ and ΙΙΙ Mandibular Furcation Defects
- ClinicalTrials.gov ID
- NCT06609720
- Acronym / sponsor ID
- OMPDR
- Conditions
- Autogenous Dentin Graft
- Keywords
- dentin graft, tooth graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 24 Sep 2024 (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.
Randomized clinical and radiographic trial
Detailed description
Evaluation of Autogenous Dentin Graft versus Demineralized Freeze-Dried Bone Allograft in the Treatment of Class ΙΙ and ΙΙΙ Mandibular Furcation Defects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 2 groups with 2 subgroups, each subgroup receive either ADG or DFDBA
| Arm | Type | Receives |
|---|---|---|
| Group 1 subgroup A | Experimental | Procedure: (guided tissue regeneration)Grade II furcation involvement treated with autogenous dentin graft |
| Group 1 Subgroup B | Experimental | Procedure: (guided tissue regeneration)Grade II furcation involvement treated with demineralized freeze-dried bone allograft |
| Group II subgroup A | Experimental | Procedure: (guided tissue regeneration)Grade III furcation involvement treated with Autogenous dentin graft |
| Group II subgroup B | Experimental | Procedure: (guided tissue regeneration)Grade III furcation involvement treated with demineralized freeze-dried bone allograft |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- -
- Presence of class II and/or ΙΙΙ furcation defects in mandibular first or second molars according to criteria outlined by Hamp et. al. 1975.
- Horizontal probing depth ≥3 mm using Naber's probe.
- Clinical attachment level ≥3 mm measured from cemento-enamel junction (CEJ) till the deepest probing depth.
- Evidence of radiolucency in the furcation area on panoramic radiograph.
Key exclusion criteria (5 listed)
- Medically compromised patients and systemic conditions precluding periodontal surgery.
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 |
|---|---|---|
| (guided tissue regeneration)Randomized clinical and radiographic trial | Procedure or surgery | Group 1 Subgroup B, Group 1 subgroup A, Group II subgroup A, Group II subgroup B |
Primary outcome
Probing pocket depth
Time frame: Measured at baseline, 6 months and 12 months
According to Ramfjord, clinical parameter measured by UNC periodontal probe from a fixed point to the deepest probing depth. Using stent to standardize the measurements.
Clinical attachment level
Time frame: Measured at baseline, 6 months and 12 months
According to Ramfjord, clinical parameter measured by a Naber\'s probe. Using stent to standard measurements.
Bleeding on probing
Time frame: Measured at baseline, 6 months and 12 months
According to Ramfjord, the bleeding at each site observed after probing and recorded positive if bleeding was observed within 30 seconds, if not was recorded as negative.
1 secondary outcome
Radiographic outcome
Time frame: measured at baseline and 1 year follow up
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 24 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Autogenous Dentin Graft
Active, not recruiting
Bone Defects Reconstruction After Dentigerous Cyst Enucleation With Autogenous Demineralized Dentin Matrix- ADDM and Advanced Platelet-Rich Fibrin- A-PRF.
Impact Molar, Mandible Cyst
Recruiting
Evaluation of Dentin Graft and I-PRF With and Without Vitamin C for Post-extraction Socket Preservation
Socket Preservation
Recruiting
Post Extraction Changes After Alveolar Socket Preservation Using Autogenous Dentin Graft (ADG) Combined With Either Albumin Platelet-rich Fibrin (ALB-PRF) or Standard Platelet-rich Fibrin (PRF).
Alveolar Socket Preservation
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.
Banan L Amer, Master principal investigator
Tanta University
Samia A Darwish, Professor study director
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (guided tissue regeneration) in people with Autogenous Dentin Graft, run by Tanta 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 6 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 24 Sep 2024. 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?
Probing pocket depth (time frame: Measured at baseline, 6 months and 12 months). The study lists 3 primary outcomes in all. 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 24 Sep 2024.