Intrabony DefectPhase 3NCT05445102
Effect of Autogenous Demineralized Dentin as a Bone Graft Substitute in Management of Periodontal Intrabony Defects
A Phase 3 study testing autogenous demineralized dentin graft as bone substitute in treatment of intrabony defect in people with Intrabony Defect, run by Cairo University at 1 site in Egypt.
Trial summary
one of the ultimate goals in periodontology is to achieve periodontal regeneration and change the prognosis of questionable or hopeless teeth to maintainable.Bone substitutes have been actively used to reconstruct bony defects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intrabony Defect
- What is being tested?
- autogenous demineralized dentin graft as bone substitute in treatment of intrabony defect
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 22 May 2022to 22 Sep 2023
- Phase
- Phase 3
- 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
- Patient-related criteria:
- Motivated patient 18 years of age or order.
- Patient consulting in the outpatient clinic.
- Patient ready to perform oral hygiene instructions.
- Provide informed consent.
- Accepts the 6 months follow-up period.
Show all 10Show fewer
- Teeth related criteria:
- Tooth with one or two walled intra-bony defect, probing depth ≥ 5mm with intra osseous defect ≥ 3mm.
- Mature permanent tooth.
- Unrestorable tooth or fractured tooth beyond restoration, impacted third molar or Supernumerary tooth to be extracted and used as whole tooth graft inside the defect
Who cannot join
- Patient-related criteria:
- Medically compromised patients.
- Pregnant women.
- Uncooperative patients.
- Smokers.
- Systemic diseases that may compromise healing or bone metabolism (e.g diabetes, hyperthyroidism)
Show all 9Show fewer
- Teeth related criteria:
- Teeth with supra-bony defects.
- Teeth with grade III mobility.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
omnia alfekky, bachelor, omnia.abdlmonaem@dentistry.cu.edu.eg
weam Elbattawy, doctor, weam.elbattawy@dentistry.cu.edu.eg
About this study
Official title: Clinical and Radiographic Effect of Extracted Autogenous Demineralized Dentin as a Bone Graft Substitute in Management of Periodontal Intrabony Defects: A Case Series
one of the ultimate goals in periodontology is to achieve periodontal regeneration and change the prognosis of questionable or hopeless teeth to maintainable.Bone substitutes have been actively used to reconstruct bony defects. Four categories of bone graft materials exist: Autograft, Allograft, Alloplast, and Xenograft.many researchers paid attention to human tooth as one of the intraoral donor sites due to the chemical and structural similarity between dentin and alveolar bone since both demonstrate low crystalline hydroxyl appetite (HA) with comparable calcium-to-phosphorus ratio.
Extracted tooth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present), using a high-speed fine finishing stone and saline irrigation. The pulp chamber will be cleaned with sterile endodontic files. Subsequently, teeth will be grounded, using hand bone mill .
ADDG particles prepared by demineralization of tooth particles in 0.6N hydrochloric acid for 30 min to achieve demineralized then washed twice in saline and dried with sterile gauze. The intrabony defect will be debrided using hand and ultrasonic devices and then ADDG particles will fill the defect. Vertical or horizontal mattress sutures and additional interrupted single sutures will be performed to obtain primary closure of the interdental space. The selection of the suturing technique will be based upon the dimension of the interdental space and the thickness and height of the interdental tissues using 5-0 proline suture then follow up period at 3 months and 6 months measuring CAL which is primary outcome and radiographic bone fill , probing depth and recession which are secondary outcome.
- Conditions
- Intrabony Defect
- Being tested
- autogenous demineralized dentin graft as bone substitute in treatment of intrabony defect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autogenous demineralized dentin graft as bone substitute in treatment of intrabony defectProcedure or surgery
after extraction of tooth it will be grinded using hand bone mill and demineralized and placed in intrabony defect
| Study group | Role | What they receive |
|---|---|---|
| autogenous demineralized dentin graft as bone substitute in treatment of intrabony defect | Experimental | Not described Receives: Procedure: autogenous demineralized dentin graft as bone substitute in treatment of intrabony defect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level gain
measured by william's periodontal probe
Measured: change from baseline at 3 month and change from baseline at 6 month
Secondary outcomes (3)
Probing depth
measured by William's periodontal probe
Measured: change from baseline at 3 month and at 6 month
Radiographic bone fill
periapical radiograph using Digora system
Measured: change from baseline at 3 month and at 6 month
Recession
measured by William's periodontal probe
Measured: change from baseline at 3 month and at 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start22 May 2022
- Primary completion22 May 2023 (estimated)
- Study completion22 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrabony DefectStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Mohamed Shehata Abde Elmonaem, Cairo University
- Investigators
- weam Elbattway, doctor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445102
- Sponsor's protocol ID
- 11422
- Status last verified
- Jun 2022
- First submitted
- 28 Jun 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Effect of Extracted Autogenous Demineralized Dentin as a Bone Graft Substitute in Management of Periodontal Intrabony Defects: A Case Series
- ClinicalTrials.gov ID
- NCT05445102
- Acronym / sponsor ID
- 11422
- Conditions
- Intrabony Defect
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 May 2022 (actual)
- Primary completion
- 22 May 2023 (estimated)
- Study completion
- 22 Sep 2023 (estimated)
- First posted
- 6 Jul 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.
one of the ultimate goals in periodontology is to achieve periodontal regeneration and change the prognosis of questionable or hopeless teeth to maintainable.Bone substitutes have been actively used to reconstruct bony defects. Four categories of bone graft materials exist: Autograft, Allograft, Alloplast, and Xenograft.many researchers paid attention to human tooth as one of the intraoral donor sites due to the chemical and structural similarity between dentin and alveolar bone since both demonstrate low crystalline hydroxyl appetite (HA) with comparable calcium-to-phosphorus ratio.
Extracted tooth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present), using a high-speed fine finishing stone and saline irrigation. The pulp chamber will be cleaned with sterile endodontic files. Subsequently, teeth will be grounded, using hand bone mill .
ADDG particles prepared by demineralization of tooth particles in 0.6N hydrochloric acid for 30 min to achieve demineralized then washed twice in saline and dried with sterile gauze. The intrabony defect will be debrided using hand and ultrasonic devices and then ADDG particles will fill the defect. Vertical or horizontal mattress sutures and additional interrupted single sutures will be performed to obtain primary closure of the interdental space. The selection of the suturing technique will be based upon the dimension of the interdental space and the thickness and height of the interdental tissues using 5-0 proline suture then follow up period at 3 months and 6 months measuring CAL which is primary outcome and radiographic bone fill , probing depth and recession which are secondary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autogenous demineralized dentin graft as bone substitute in treatment of intrabony defect | Experimental | Procedure: autogenous demineralized dentin graft as bone substitute in treatment of intrabony defect |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patient-related criteria:
- Motivated patient 18 years of age or order.
- Patient consulting in the outpatient clinic.
- Patient ready to perform oral hygiene instructions.
- Provide informed consent.
Key exclusion criteria (9 listed)
- Patient-related criteria:
- Teeth with supra-bony defects.
- Teeth with grade III mobility.
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 demineralized dentin graft as bone substitute in treatment of intrabony defectafter extraction of tooth it will be grinded using hand bone mill and demineralized and placed in intrabony defect | Procedure or surgery | autogenous demineralized dentin graft as bone substitute in treatment of intrabony defect |
Primary outcome
Clinical attachment level gain
Time frame: change from baseline at 3 month and change from baseline at 6 month
measured by william's periodontal probe
3 secondary outcomes
Probing depth
Time frame: change from baseline at 3 month and at 6 month
Radiographic bone fill
Time frame: change from baseline at 3 month and at 6 month
Recession
Time frame: change from baseline at 3 month and at 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
Related trials for Intrabony Defect
Recruiting
A Closed Surgical Technique vs Modified Papilla Preservation Technique
Intrabony Periodontal Defect, Treatment
Recruiting
Treating Intrabony Defect With MINST VS MINST Extended PRF
Periodontal Intrabony Defects
Recruiting
Treatment of Intrabony Defects With Injectable Platelet-Rich Fibrin and Xenogenic Grafts
Periodontitis, Intrabony Periodontal Defect
Not yet recruiting
Alb-PRF as an Adjunct to Regenerative Periodontal Surgery
Periodontitis, Periodontitis Stage III
Recruiting
Flapless Periodontal Regeneration Using Hyaluronic Acid Versus Enamel Matrix Derivative
Guided Tissue Regeneration, Periodontal / Methods, Dental Enamel Proteins* / Therapeutic Use
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.
weam Elbattway, doctor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing autogenous demineralized dentin graft as bone substitute in treatment of intrabony defect in people with Intrabony Defect, 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 10 inclusion and 9 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 Jul 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 omnia alfekky, bachelor (1019604560 ext. +20, omnia.abdlmonaem@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical attachment level gain (time frame: change from baseline at 3 month and change from baseline at 6 month). 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 Jul 2022.