Back to resultsTooth Autotransplantation and Bone Dimension Changes
Primary Purpose
Bone Loss, Alveolar, Tooth Loss, Bone Atrophy, Alveolar
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
AUTOTRANSPLANTATION TOOTH
Sponsored by
About this trial
This is an interventional treatment trial for Bone Loss, Alveolar
Eligibility Criteria
Inclusion Criteria:
- Tooth with imposible prognosis
- Plaque index score less than 30%
- No relevant systemic disease
- Smokers (Less than 20 cigars/day)
Exclusion Criteria:
- Pregnancy-Lactation
- Relevant systemic disease
Sites / Locations
- Universidad de MurciaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AUTOTRANSPLANTATION TOOTH
Arm Description
Outcomes
Primary Outcome Measures
Change in alveolar bone 12 months after tooth autotransplantation
CT-scan evaluation before surgery and 1 year after, measuring the difference in millimeters
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03927937
Brief Title
Tooth Autotransplantation and Bone Dimension Changes
Official Title
Tooth Autotransplantation and Bone Dimension Changes. Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Murcia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Tooth autotransplantation is a treatment option to replace tooth with imposible prognosis. In several cases the receipt site has a reduced bone dimension. This situation may be imposible the treatment with dental implants without bone reconstruction. Autotransplantation seem to improve the anatomic characteristic of the receipt site without any reconstruction approach.
The aim of this study is to evaluate the bone dimension changes followed autotransplantation treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Alveolar, Tooth Loss, Bone Atrophy, Alveolar
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AUTOTRANSPLANTATION TOOTH
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
AUTOTRANSPLANTATION TOOTH
Intervention Description
Tooth with imposible prognosis is replace with a healthy tooth from the same patient.
Primary Outcome Measure Information:
Title
Change in alveolar bone 12 months after tooth autotransplantation
Description
CT-scan evaluation before surgery and 1 year after, measuring the difference in millimeters
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Tooth with imposible prognosis
Plaque index score less than 30%
No relevant systemic disease
Smokers (Less than 20 cigars/day)
Exclusion Criteria:
Pregnancy-Lactation
Relevant systemic disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miguel Ramón P Pecci Lloret, DDS
Phone
630492610
Email
miguelr.pecci@gmail.com
Facility Information:
Facility Name
Universidad de Murcia
City
Murcia
ZIP/Postal Code
30003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Ramón PECCI LLORET
Phone
630492610
Email
miguelr.pecci@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Tooth Autotransplantation and Bone Dimension Changes
We'll reach out to this number within 24 hrs