Tooth MobilityNCT06457867
Assessment of Microfragmented Adipose Tissue Loaded on Bovine Graft Versus Bovine Graft Only on Ridge Preservation.
A study testing microfragmented adipose tissue loaded on bovine graft in people with Tooth Mobility, run by Cairo University.
Trial summary
Evaluation of maxillary alveolar ridge changes (bone quantity and quality as revealed by Radiographic and Histomorphometry) utilizing microfragmented adipose tissue loaded on bovine graft versus bovine graft only for maxillary posterior ridge preservation. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Mobility
- What is being tested?
- microfragmented adipose tissue loaded on bovine graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Mar 2025
- 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients requiring implant treatment after tooth extraction due to either unrestorable caries lesions or affected periodontium.
- Age group: above 21 years
- Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.
Who cannot join
- General contraindications to implant surgery.
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Poor oral hygiene and motivation.
- Severe bruxism or clenching.
- Systemic, immunologic, or debilitating diseases that could affect normal bone healing \& local pathosis.
- Treated or under treatment of intravenous amino bisphosphonates.
Show all 9Show fewer
- Active infection or severe inflammation in the area intended for implant placement.
- Patients participating in other studies if the present protocol could not be properly followed.
- Heavy smokers
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Radiographic and Histomorphometric Assessment of Microfragmented Adipose Tissue Loaded on Bovine Graft on Ridge Preservation Versus Bovine Graft Only for Subsequent Implant Placement in the Maxillary Posterior Region, a Randomized Clinical Trial.
Evaluation of maxillary alveolar ridge changes (bone quantity and quality as revealed by Radiographic and Histomorphometry) utilizing microfragmented adipose tissue loaded on bovine graft versus bovine graft only for maxillary posterior ridge preservation.
Read the detailed description
All patients involved in this study will be divided into two groups; each group will receive a different graft of bone augmentation: Adipose tissue loaded on bovine graft will be utilized for the study group and bovine raft only for the control group.
After 6 months, patients will be evaluated histomorphometrically via core biopsy at the time of implant placement and radiographically via assessment of ridge height on CBCT.
Radiographic assessment that will be achieved by CBCT scan will be used to calculate the changes of bone height from base line (1week) to 6 months postoperatively.
- Conditions
- Tooth Mobility
- Being tested
- microfragmented adipose tissue loaded on bovine graft
- Keywords
- unrestorable caries lesions or affected periodontium.
- Medical subject headings
- Tooth Mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microfragmented adipose tissue loaded on bovine graftProcedure or surgery
microfragmented adipose tissue loaded on bovine graft on ridge preservation
| Study group | Role | What they receive |
|---|---|---|
| microfragmented adipose tissue | Experimental | microfragmented adipose tissue loaded on bovine graft on ridge preservation Receives: Procedure: microfragmented adipose tissue loaded on bovine graft |
| bovine graft | Active comparator | bovine graft only on ridge preservation Receives: Procedure: microfragmented adipose tissue loaded on bovine graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of bone (vertical bone height)
By CBCT
Measured: Quantity of bone (vertical bone height) by CBCT after 6 months
Secondary outcomes (1)
Quality of bone
Histological analysis (Core biopsy) Percentage of newly formed bone
Measured: Histological analysis (Core biopsy) Percentage of newly formed bone after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth MobilityStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bashaer Maruf Jamaan Bayashot, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457867
- Sponsor's protocol ID
- microfragmented adipose tissue
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All patients involved in this study will be divided into two groups; each group will receive a different graft of bone augmentation: Adipose tissue loaded on bovine graft will be utilized for the study group and bovine raft only for the control group. For both groups: All Patients of both groups will be evaluated radiographically immediately and after 6 months post-operative by cone beam CT scan to record Alveolar ridge height.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic and Histomorphometric Assessment of Microfragmented Adipose Tissue Loaded on Bovine Graft on Ridge Preservation Versus Bovine Graft Only for Subsequent Implant Placement in the Maxillary Posterior Region, a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06457867
- Acronym / sponsor ID
- microfragmented adipose tissue
- Conditions
- Tooth Mobility
- Keywords
- unrestorable caries lesions or affected periodontium.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 13 Jun 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.
Evaluation of maxillary alveolar ridge changes (bone quantity and quality as revealed by Radiographic and Histomorphometry) utilizing microfragmented adipose tissue loaded on bovine graft versus bovine graft only for maxillary posterior ridge preservation.
Detailed description
All patients involved in this study will be divided into two groups; each group will receive a different graft of bone augmentation: Adipose tissue loaded on bovine graft will be utilized for the study group and bovine raft only for the control group.
After 6 months, patients will be evaluated histomorphometrically via core biopsy at the time of implant placement and radiographically via assessment of ridge height on CBCT.
Radiographic assessment that will be achieved by CBCT scan will be used to calculate the changes of bone height from base line (1week) to 6 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| microfragmented adipose tissue | Experimental | Procedure: microfragmented adipose tissue loaded on bovine graftmicrofragmented adipose tissue loaded on bovine graft on ridge preservation |
| bovine graft | Active comparator | Procedure: microfragmented adipose tissue loaded on bovine graftbovine graft only on ridge preservation |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients requiring implant treatment after tooth extraction due to either unrestorable caries lesions or affected periodontium.
Key exclusion criteria (9 listed)
- General contraindications to implant 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 |
|---|---|---|
| microfragmented adipose tissue loaded on bovine graftmicrofragmented adipose tissue loaded on bovine graft on ridge preservation | Procedure or surgery | bovine graft, microfragmented adipose tissue |
Primary outcome
Quantity of bone (vertical bone height)
Time frame: Quantity of bone (vertical bone height) by CBCT after 6 months
By CBCT
1 secondary outcome
Quality of bone
Time frame: Histological analysis (Core biopsy) Percentage of newly formed bone after 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: Yes. All patients involved in this study will be divided into two groups; each group will receive a different graft of bone augmentation: Adipose tissue loaded on bovine graft will be utilized for the study group and bovine raft only for the control group. For both groups: All Patients of both groups will be evaluated radiographically immediately and after 6 months post-operative by cone beam CT scan to record Alveolar ridge height.
Related trials for Tooth Mobility
Active, not recruitingObservational study
Comparison Physiological Tooth Mobility and Retention Success in Patients Using Different Retainers
Orthodontic Retainers, Tooth Mobility
Active, not recruiting
Comparison of Replantation and Splinting Alone in Lower Anterior Teeth
Periodontitis
Recruiting
Evaluating the Effect of Injectable Platelet-rich Fibrin on Accelerating Orthodontic Tooth Movement
Tooth Mobility, Injectable Platelet-rich Fibrin
Active, not recruitingObservational study
Restorative and Periodontal Evaluation of Fiber-Reinforced Periodontal Splints
Periodontitis, Tooth Mobility
Not yet recruitingObservational study
Physical Activity Level at Home in CMT1A Patients: Wearable Sensor Assessment
Charcot-Marie-Tooth Disease, Type IA, Peripheral Neuropathy Hereditary
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.
Questions about this trial
What is this clinical trial studying?
A study testing microfragmented adipose tissue loaded on bovine graft in people with Tooth Mobility, 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 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 13 Jun 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. 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?
Contact Bshaer Bayashot, BDS (01064825199, bshaer.bayashot@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity of bone (vertical bone height) (time frame: Quantity of bone (vertical bone height) by CBCT after 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 13 Jun 2024.