Hopeless ToothNCT06636461
Assessment of Dimensional Changes Following Grafting With Microfragmented Adipose Tissue Loaded on Allograft on Ridge Preservation
A study testing microfragmented adipose tissue loaded on allograft in people with Hopeless Tooth, run by Cairo University at 1 site in Egypt.
Trial summary
Evaluation of maxillary alveolar ridge changes (bone quantity and quality as revealed by radiographic and Histomorphometry ) utilizing microfragmented adipose tissue loaded on allograft versus allograft 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
- Hopeless Tooth
- What is being tested?
- microfragmented adipose tissue loaded on allograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to 1 Feb 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 18 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 somkers
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo Universty
Cairo, Giza Governorate
hesham Elhawary, prof, 01144446373, hesham.elhawary@dentistry.cu.edu.eg
Maha Alnahdi, BDS, 01559975945, maha.alnahdi@dentistry.cu.edu.eg
About this study
Official title: Assessment of Dimensional Changes Following Grafting With Microfragmented Adipose Tissue Loaded on Allograft on Ridge Preservation Versus Allograft 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 allograft versus allograft 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 allograft will be utilized for the study group and allograft only for the control group.
After 3-6 months, assessment of dimensional changes ( RG height \& width) on CBCT is performed and Histomorphometry will be evaluated via core biopsy at the time of implant placement in both groups.
Radiographic assessment that will be achieved by CBCT scan will be used to calculate the changes of bone height and width from base line (1week) to 3-6 months postoperatively.
- Conditions
- Hopeless Tooth
- Being tested
- microfragmented adipose tissue loaded on allograft
- Keywords
- hopeless tooth lesion or affected periodontium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microfragmented adipose tissue loaded on allograftProcedure or surgery
microfragmented adipose tissue loaded on allograft on ridge preservation
| Study group | Role | What they receive |
|---|---|---|
| microfragmented adipose tissue | Experimental | microfragmented adipose tissue loaded on allograft on ridge preservation Receives: Procedure: microfragmented adipose tissue loaded on allograft |
| allograft | Active comparator | allograft only on ridge preservation Receives: Procedure: microfragmented adipose tissue loaded on allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar ridge hight (bone quantity )
By CBCT
Measured: Alveolar ridge hight (bone quantity ) by CBCT after 3-6 months
Secondary outcomes (1)
Alveolar ridge width.
By CBCT
Measured: Alveolar ridge width. by CBCT after 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hopeless ToothStudies 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
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Omar Salem Alnahdi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636461
- Sponsor's protocol ID
- Assessment of dimensional chan
- Status last verified
- Oct 2024
- First submitted
- 2 Sep 2024
- Last updated
- 10 Oct 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 allograft will be utilized for the study group and allograft only for the control group. For both groups: All Patients of both groups will be evaluated radiographically immediately and after 3- 6 months post-operative by cone beam CT scan to record Alveolar ridge height and width.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dimensional Changes Following Grafting With Microfragmented Adipose Tissue Loaded on Allograft on Ridge Preservation Versus Allograft Only for Subsequent Implant Placement in the Maxillary Posterior Region, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06636461
- Acronym / sponsor ID
- Assessment of dimensional chan
- Conditions
- Hopeless Tooth
- Keywords
- hopeless tooth lesion or affected periodontium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 10 Oct 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 allograft versus allograft 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 allograft will be utilized for the study group and allograft only for the control group.
After 3-6 months, assessment of dimensional changes ( RG height \& width) on CBCT is performed and Histomorphometry will be evaluated via core biopsy at the time of implant placement in both groups.
Radiographic assessment that will be achieved by CBCT scan will be used to calculate the changes of bone height and width from base line (1week) to 3-6 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 allograftmicrofragmented adipose tissue loaded on allograft on ridge preservation |
| allograft | Active comparator | Procedure: microfragmented adipose tissue loaded on allograftallograft 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.
- Age group: above 18 years
- Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.
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 allograftmicrofragmented adipose tissue loaded on allograft on ridge preservation | Procedure or surgery | allograft, microfragmented adipose tissue |
Primary outcome
Alveolar ridge hight (bone quantity )
Time frame: Alveolar ridge hight (bone quantity ) by CBCT after 3-6 months
By CBCT
1 secondary outcome
Alveolar ridge width.
Time frame: Alveolar ridge width. by CBCT after 3-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 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 allograft will be utilized for the study group and allograft only for the control group. For both groups: All Patients of both groups will be evaluated radiographically immediately and after 3- 6 months post-operative by cone beam CT scan to record Alveolar ridge height and width.
Related trials for Hopeless Tooth
Enrolling by invitation
Peri-implant Tissue Changes Using Dual Zone Concept With Connective Tissue Graft Versus Concentrated Growth Factor
Hopeless Tooth in Esthetic Zone, Loss of Soft and Hard Tissue Around Implant
Active, not recruiting
Comparison of Replantation and Splinting Alone in Lower Anterior Teeth
Periodontitis
Recruiting
To Compare Post-Extraction Use of a Novel Ethylenediaminetetraacetic Acid (EDTA) Post-operative Mouth Rinse and Daily Use EDTA Mouth Rinse and Standard 0.12% Chlorhexidine (CHX) Post-operative Mouth Rinse and Daily Use Essential Oil (EO) Mouth Rinse.
Extraction Sites After Removal and Bone Replacement Grafting at Extraction Sockets of Dentally Hopeless Single-rooted Teeth
Enrolling by invitation
Immediate Dental Implant Installation With and Without Socket Shield Technique in Aesthetic Zone
Immediate Dental Implants, Thin Labial Plate of Bone Pre-extraction
Recruiting
Performance of Next-X in Alveolar Ridge Preservation
Hopeless Tooth
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microfragmented adipose tissue loaded on allograft in people with Hopeless Tooth, 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 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 10 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact maha alnahdi, BDS (01145684357 ext. 01559975945, maha.alnahdi@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alveolar ridge hight (bone quantity ) (time frame: Alveolar ridge hight (bone quantity ) by CBCT after 3-6 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 10 Oct 2024.