Periodontal Bone DefectsPhase 3NCT06553222
Minimally Invasive Non-surgical Therapy With or Without Injectable Bone Putty
A Phase 3 study testing Putty bone - Tricalcium phosphate with Collagen gel in people with Periodontal Bone Defects, run by Al-Azhar University.
Trial summary
All periodontitis patients with infra bony pockets to be included in this study will diagnosed as having stage III periodontitis with probing pocket depth (PPD) ≥ 6 mm, and clinical attachment loss (CAL) ≥ 5mm will be treated by minimally invasive non-surgical therapy or by injectable bone putty Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Bone Defects
- What is being tested?
- Putty bone - Tricalcium phosphate with Collagen gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 4 Nov 2024to 4 Dec 2025
- 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 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • All periodontitis patients to be included in this study should be diagnosed as having stage III periodontitis with probing pocket depth (PPD) ≥ 6 mm, and clinical attachment loss (CAL) ≥ 5mm.
- 2- or 3-wall intra-bony interproximal defect with depth ≥3 mm, a width of ≥3 mm at its most coronal part and 45-55-degree angulation will be selected in order to reduce defect variability
- All patients will be free from any systemic diseases according to the American Dental Academy general guidelines for referring dental patients to specialists and other care settings.
Who cannot join
- Any patients with any systemic condition that contraindicate any surgical intervention
About this study
Official title: Minimally Invasive Non-surgical Therapy With or Without Injectable Bone Putty in Treating Intra-bony Periodontal Defects (Randomized Controlled Clinical Trial)
- All periodontitis patients with infra bony pockets to be included in this study will diagnosed as having stage III periodontitis with probing pocket depth (PPD) ≥ 6 mm, and clinical attachment loss (CAL) ≥ 5mm will be treated by minimally invasive non-surgical therapy or by injectable bone putty
Read the detailed description
The present study will be designed as a randomized controlled clinical and radiographic. The study will be carried out on stage III grade (B) periodontitis patients with intra-bony defects. Those patients will be selected from the outpatient clinics of the Department of Oral Medicine and Periodontology, Faculty of Dental Medicine, Al-Azhar University, Assiut branch.
The study has bee approved by the ethical committee, Faculty of Dental medicine, Al-Azhar University, Assiut branch.
- All patients will be fully informed about the study's nature and the possible risks of the study procedures; they sign the consent form before the work.
- Conditions
- Periodontal Bone Defects
- Being tested
- Putty bone - Tricalcium phosphate with Collagen gel
- Keywords
- periodontal bone defect -bone putty -infrabony defect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Putty bone - Tricalcium phosphate with Collagen gelBiological
Minimally invasive debridement periodontal flap and Bone graft placement to augment the lost alveolar bone
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Participants receives Injectable bone putty - Minimally invasive debridement periodontal flap plus putty bone graft in three osseous wall defect Receives: Biological: Putty bone - Tricalcium phosphate with Collagen gel |
| Control group | Placebo comparator | - Participants receive No graft (No drug) Minimally invasive debridement periodontal flap Receives: Biological: Putty bone - Tricalcium phosphate with Collagen gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
measurement (mm) in alveolar bone gain
Measured: measured at 6 and 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start4 Nov 2024 (estimated)
- Primary completion4 Oct 2025 (estimated)
- Study completion4 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal Bone DefectsStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 parallel groups study group - The interventional group where minimally invasive debridement flap and a putty bone graft is tested and the Control group - where minimally invasive debridement flap is performed without graft
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Ahmed Saad, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553222
- Sponsor's protocol ID
- AUAREC20240007-5
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Non-surgical Therapy With or Without Injectable Bone Putty in Treating Intra-bony Periodontal Defects (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06553222
- Acronym / sponsor ID
- AUAREC20240007-5
- Conditions
- Periodontal Bone Defects
- Keywords
- periodontal bone defect -bone putty -infrabony defect
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 4 Nov 2024 (estimated)
- Primary completion
- 4 Oct 2025 (estimated)
- Study completion
- 4 Dec 2025 (estimated)
- First posted
- 14 Aug 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.
- All periodontitis patients with infra bony pockets to be included in this study will diagnosed as having stage III periodontitis with probing pocket depth (PPD) ≥ 6 mm, and clinical attachment loss (CAL) ≥ 5mm will be treated by minimally invasive non-surgical therapy or by injectable bone putty
Detailed description
The present study will be designed as a randomized controlled clinical and radiographic. The study will be carried out on stage III grade (B) periodontitis patients with intra-bony defects. Those patients will be selected from the outpatient clinics of the Department of Oral Medicine and Periodontology, Faculty of Dental Medicine, Al-Azhar University, Assiut branch.
The study has bee approved by the ethical committee, Faculty of Dental medicine, Al-Azhar University, Assiut branch.
- All patients will be fully informed about the study's nature and the possible risks of the study procedures; they sign the consent form before the work.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2 parallel groups study group - The interventional group where minimally invasive debridement flap and a putty bone graft is tested and the Control group - where minimally invasive debridement flap is performed without graft
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Biological: Putty bone - Tricalcium phosphate with Collagen gelParticipants receives Injectable bone putty - Minimally invasive debridement periodontal flap plus putty bone graft in three osseous wall defect |
| Control group | Placebo comparator | Biological: Putty bone - Tricalcium phosphate with Collagen gel- Participants receive No graft (No drug) Minimally invasive debridement periodontal flap |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • All periodontitis patients to be included in this study should be diagnosed as having stage III periodontitis with probing pocket depth (PPD) ≥ 6 mm, and clinical attachment loss (CAL) ≥ 5mm.
Key exclusion criteria (1 listed)
- Any patients with any systemic condition that contraindicate any surgical intervention
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 |
|---|---|---|
| Putty bone - Tricalcium phosphate with Collagen gelMinimally invasive debridement periodontal flap and Bone graft placement to augment the lost alveolar bone | Biological | Control group, Interventional |
Primary outcome
Primary outcome
Time frame: measured at 6 and 12 months postoperative
measurement (mm) in alveolar bone gain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
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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 Phase 3 study testing Putty bone - Tricalcium phosphate with Collagen gel in people with Periodontal Bone Defects, run by Al-Azhar 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 1 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 14 Aug 2024. 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. Some participants in this study may receive a placebo. 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?
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?
Primary outcome (time frame: measured at 6 and 12 months postoperative). 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 14 Aug 2024.