Tooth Autotransplantation and Bone Dimension Changes | NCT03927937

Studies
Tooth Autotransplantation and Bone Dimension Changes

NCT03927937

Sponsor

Universidad de Murcia

Status

Unknown status

Last Update Posted

Apr 25, 2019Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Bone Loss, Alveolar
Tooth Loss
Bone Atrophy, Alveolar

Interventions

AUTOTRANSPLANTATION TOOTH

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 5, 2018Actual

Primary Completion Date

Dec 30, 2019Estimated

Completion Date

Jun 30, 2020Estimated

First Submitted Date

Apr 20, 2019

First Submission Date that Met QC Criteria

Apr 23, 2019

First Posted Date

Apr 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2019

Last Update Posted Date

Apr 25, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AUTOTRANSPLANTATION TOOTH	Experimental		Procedure: AUTOTRANSPLANTATION TOOTH

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AUTOTRANSPLANTATION TOOTH	Procedure	Tooth with imposible prognosis is replace with a healthy tooth from the same patient.	AUTOTRANSPLANTATION TOOTH

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in alveolar bone 12 months after tooth autotransplantation	CT-scan evaluation before surgery and 1 year after, measuring the difference in millimeters	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Miguel Ramón P Pecci Lloret, DDS	Contact	630492610		miguelr.pecci@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidad de Murcia	Recruiting	Murcia		30003	Spain

Condition Browse Module

MeSH Terms

ID	Term
D016301	Alveolar Bone Loss
D016388	Tooth Loss

Ancestor Terms

ID	Term
D001862	Bone Resorption
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D055093	Periodontal Atrophy

Browse Leaves

Not provided

Browse Branches

Not provided