Autotransplantation of Wisdom TeethNCT06553300
Auto Transplantation of Wisdom Teeth
A study testing Autotransplantation with PRF and Autotransplatation Only in people with Autotransplantation of Wisdom Teeth and Patelet Rich Fibrin, run by Cleveland Dental Institute at 1 site in United States.
Trial summary
Autotransplantation emerges as a viable alternative to tooth extraction and prosthetic restoration when conventional endodontic treatments are unfeasible or contraindicated. The success of autotransplantation is influenced by diverse factors, including root development stage, tooth morphology, surgical technique… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Autotransplantation of Wisdom Teeth, Patelet Rich Fibrin
- What is being tested?
- Autotransplantation with PRF and Autotransplatation Only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 31 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- male and female
- aged between 20 and 50 years
- devoid of systemic ailments
- complying with the study procedures
- holding an Anesthesiologists classification of 1 or 2
- possessing mandibular or maxillary immature wisdom teeth
Who cannot join
- systemic diseases that might impede the healing process
- Patients with pacemakers
- Individuals harboring allergies to medications or antibiotics
- active smokers
- patients afflicted with periodontal diseases
Trial locations and contacts
1 site in 1 country.
Nelza Baladi, DDS contact
United States1 site, 1 recruiting
- Recruiting
Cleveland Dental Institute
Cleveland, Ohio, 44128
Waleed Elmallah, DDS, 216-727-0234
Luis M De la Rosa, DDS
About this study
Official title: Auto Transplantation of Wisdom Teeth With or Without Platelet Rich Fibrin for Replacement of Non-Restorable Posterior Teeth.
Autotransplantation emerges as a viable alternative to tooth extraction and prosthetic restoration when conventional endodontic treatments are unfeasible or contraindicated. The success of autotransplantation is influenced by diverse factors, including root development stage, tooth morphology, surgical technique, extraoral duration, recipient socket shape, recipient bed vascularity, and periodontal ligament cell vitality. Preserving periodontal ligament quality and achieving tissue adaptation are pivotal for successful tooth transplantation. Successful donor tooth replacement is influenced by variables like fitting attempts, alveolus-root distance, extra-alveolar time, surgical skill, and extraction trauma intensity.
- Being tested
- Autotransplantation with PRF, Autotransplatation Only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autotransplantation with PRFProcedure or surgery
Autotransplantation of Wisdom teeth to the extracted socket of removed broken down posterior teeth with the application of PRF
Autotransplatation OnlyProcedure or surgery
Autotransplantation of Wisdom teeth to the extracted socket of removed broken down posterior teeth.
| Study group | Role | What they receive |
|---|---|---|
| Autotransplantation with PRF | Experimental | Not described Receives: Procedure: Autotransplantation with PRF |
| Autotrasplantation only | Active comparator | Not described Receives: Procedure: Autotransplatation Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic success
The success of auto-transplanted immature third molars with and without Platelet-Rich Fibrin will be assessed over a year period.
Measured: one year
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 start1 Jan 2024
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autotransplantation of Wisdom TeethStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cleveland Dental Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Waleed Elmallah, DDS, Study chair, Cleveland DentalAhmed Hashem, DDS, Study director, Cleveland Dental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553300
- Sponsor's protocol ID
- CDIOS00011
- Status last verified
- Jul 2024
- First submitted
- 29 Jul 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
- Auto Transplantation of Wisdom Teeth With or Without Platelet Rich Fibrin for Replacement of Non-Restorable Posterior Teeth.
- ClinicalTrials.gov ID
- NCT06553300
- Acronym / sponsor ID
- CDIOS00011
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cleveland Dental InstituteUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Mar 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.
Autotransplantation emerges as a viable alternative to tooth extraction and prosthetic restoration when conventional endodontic treatments are unfeasible or contraindicated. The success of autotransplantation is influenced by diverse factors, including root development stage, tooth morphology, surgical technique, extraoral duration, recipient socket shape, recipient bed vascularity, and periodontal ligament cell vitality. Preserving periodontal ligament quality and achieving tissue adaptation are pivotal for successful tooth transplantation. Successful donor tooth replacement is influenced by variables like fitting attempts, alveolus-root distance, extra-alveolar time, surgical skill, and extraction trauma intensity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autotransplantation with PRF | Experimental | Procedure: Autotransplantation with PRF |
| Autotrasplantation only | Active comparator | Procedure: Autotransplatation Only |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- male and female
- aged between 20 and 50 years
- devoid of systemic ailments
- complying with the study procedures
- holding an Anesthesiologists classification of 1 or 2
Key exclusion criteria (5 listed)
- systemic diseases that might impede the healing process
- Patients with pacemakers
- Individuals harboring allergies to medications or antibiotics
- active smokers
- patients afflicted with periodontal diseases
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 |
|---|---|---|
| Autotransplantation with PRFAutotransplantation of Wisdom teeth to the extracted socket of removed broken down posterior teeth with the application of PRF | Procedure or surgery | Autotransplantation with PRF |
| Autotransplatation OnlyAutotransplantation of Wisdom teeth to the extracted socket of removed broken down posterior teeth. | Procedure or surgery | Autotrasplantation only |
Primary outcome
Radiographic success
Time frame: one year
The success of auto-transplanted immature third molars with and without Platelet-Rich Fibrin will be assessed over a year period.
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.
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.
Nelza Baladi, DDS contact
Waleed Elmallah, DDS study chair
Cleveland Dental
Ahmed Hashem, DDS study director
Cleveland Dental
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autotransplantation with PRF and Autotransplatation Only in people with Autotransplantation of Wisdom Teeth and Patelet Rich Fibrin, run by Cleveland Dental Institute at 1 site in United States.
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: 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.
Where is the study taking place?
The record lists 1 site in United States. 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 Luis M De la Rosa, DDS (917-861-5881, l.delarosa@cdiohio.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic success (time frame: one year). 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; AzTrials last refreshed its copy on 6 Nov 2026.