- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05669118
Dental Autotransplantation or Immediate Single Implant for the Replacement of a Hopeless Molar.
Dental Autotransplantation or Immediate Single Implant for the Replacement of a Hopeless Molar: a Comparative Case Series Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Dental autotransplantation has high levels of success in permanent teeth with open apex. The results of success in permanent teeth with closed apex are somewhat lower but sufficient to consider the treatment as a viable alternative and to extend the therapeutic range of the treatment to older ages.
The aim of this prospective observational investigation is to evaluate the dimensional and attachment changes that occur in the treated areas and in the autotransplanted teeth respectively of adult patients with permanent teeth with closed apex. All adult patients receiving a dental autotransplantation between the years 2022 and 2023 will be included.
Pre-treatment, volume and insertion parameters will be recorded before and one year after treatment. The comparison with the extraction and dental implant treatment will be made using the digital records that are usually obtained during the performance of this treatment. The comparison will be made with the same number of patients who have been recruited for the dental autotransplant treatment, and the volumetric changes that occur will also be analyzed.
The volume comparisons will be carried out using the Medit Link digital measurement software (Medit, Seoul, Republic of Korea) and data will be obtained and analyzed statistically in order to draw the appropriate conclusions.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Alicante, Spain, 03001
- Clínica Dental Esteve
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients in ASA-I health status
- Aged between 18 and 80 years,
- Present a tooth in need of extraction with a mature candidate donor tooth compatible with the recipient bed
- Acceptance of proposed treatment of dental autotransplantation
Exclusion Criteria:
- Unavailability of a candidate donor tooth
- Refusal of proposed treatment of dental autotransplantation
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Autotransplantation
Patients who receive one tooth autotransplanted.
|
Place another tooth in the place of the newly extracted tooth in the same patient.
Other Names:
|
Immediate implant
Patients who receive one inmediate dental implant.
|
Place a dental implant immediately after tooth extraction.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Soft tissue volume changes
Time Frame: 2 times measurement: day 0 and 6 months after
|
Soft tissue volume changes in the buccal side of the site in mm3
|
2 times measurement: day 0 and 6 months after
|
Periodontal probing pocket depth
Time Frame: 6 months after
|
Periodontal probing pocket depth in mm
|
6 months after
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients satisfaction after treatment
Time Frame: 6 months after the reception of the treatment
|
Satisfaction assessed by Numeric Rating Scale (NRS) form 0 to 10, being 0 "not satisfied at all" and 10 "very satisfied".
|
6 months after the reception of the treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guillem Esteve-Pardo, PhD, Clínica Dental Esteve
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PROSP AUTO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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