Emdogain Adjunctive to Autotransplantation (ATTEMD)

May 7, 2024 updated by: Ignacio Pedrinaci Peñalver, Universidad Complutense de Madrid

Efficacy of Enamel Matrix Derivatives Adjunctive to Closed-apex Teeth Autotransplantation A Randomized Clinical Trial

The goal of this randomized clinical trial is to compare the adjunctive use of enamel matrix derivatives in the treatment of tooth autotransplantation in terms of clinical attachment level. The main question it aims to answer. What is the benefit, in terms of clinical attachment level and probing depths, of using enamel matrix derivatives adjunctive to tooth autotransplantation? Participants will be subjected to a digitally guided surgery of tooth autotransplantation. The protocol of the test group will be supplemented with the application of enamel matrix derivatives before the placement of the transplanted tooth into the surgically produced alveolus.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28003
        • Recruiting
        • Universidad Complutense de Madrid
        • Contact:
        • Principal Investigator:
          • Ignacio Pedrinaci

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: Adult patients attending the University Complutense of Madrid for dental treatment were eligible to participate in the study if they met the following criteria:

  • adults (≥18 years old) capable of providing informed consent, teeth deemed-unrestorable in need of replacement
  • presence of a viable, healthy, periodontally stable, and nonfunctional tooth (e.g., third molar) suitable for autotransplantation
  • periodontally healthy individuals or those with stable periodontal conditions after periodontal therapy.

Exclusion Criteria:

  • clinical attachment loss of the donor teeth (CAL less 6 mm)
  • compromised general health or patients with systemic diseases that could influence the therapy outcome (uncontrolled diabetes mellitus, bone disorders, etc.)
  • pregnant or nursing women
  • chronic use of corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or immune-modulator drugs
  • patients requiring medications that affect bone metabolism (bisphosphonates
  • chronic oral mucosa diseases
  • evident signs of severe bruxism or clenching habits
  • smokers of more than 10 cigarettes per day
  • non-compliant patients with 25% plaque index at the time of re-evaluation after non-surgical periodontal therapy and oral hygiene instructions
  • patients unable to attend study-related procedures and follow-up visits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Control
Procedure: Sham group
Initially, tooth sectioning of the hopeless tooth (receptor) will be carried out using fissure carbide burs, and the resulting two fragments will be extracted with a minimally invasive approach. A multiple drilling axis tooth-supported surgical guide will be used to prepare the recipient site in accordance with the 3D planning. Additional alveoloplasty procedures will be performed with round diamond burs if necessary to adapt thecomputer assisted rapid prototyping (CARP) model to the virtual planning position. The donor tooth will be extracted as atraumatically as possible, utilizing a piezoelectric surgical instrument if ostectomy is required, and avoiding the use of elevators or forceps over the root surface. No Emdodain (EMD). Sutures will be applied to closely adapt the soft tissues around the autotransplanted tooth. A semi-rigid orthodontic wire will be used to splint the tooth to the mesial and distal adjacent teeth
Active Comparator: Emdogain (EMD)
Biological: Emdogain (EMD) - test
Initially, tooth sectioning of the hopeless tooth (receptor) will be carried out using fissure carbide burs, and the resulting fragments will be extracted with a minimally invasive approach. A multiple drilling axis tooth-supported surgical guide will be used to prepare the recipient site in accordance with the 3D planning. Additional alveoloplasty procedures will be performed with round diamond burs if necessary to adapt the computer assisted rapid prototyping (CARP) model to the virtual planning position. The donor tooth will be extracted as atraumatically as possible, utilizing a piezoelectric if ostectomy is required, and avoiding the use of elevators or forceps over the root surface. Extraorally, (Emdogain) EMD will be applied to the root surface of the donor tooth. Sutures will be applied to closely adapt the soft tissues around the autotransplanted tooth. A semi-rigid orthodontic wire will be used to splint the tooth to the mesial and distal adjacent teeth
Procedure: Sham group
Initially, tooth sectioning of the hopeless tooth (receptor) will be carried out using fissure carbide burs, and the resulting two fragments will be extracted with a minimally invasive approach. A multiple drilling axis tooth-supported surgical guide will be used to prepare the recipient site in accordance with the 3D planning. Additional alveoloplasty procedures will be performed with round diamond burs if necessary to adapt thecomputer assisted rapid prototyping (CARP) model to the virtual planning position. The donor tooth will be extracted as atraumatically as possible, utilizing a piezoelectric surgical instrument if ostectomy is required, and avoiding the use of elevators or forceps over the root surface. No Emdodain (EMD). Sutures will be applied to closely adapt the soft tissues around the autotransplanted tooth. A semi-rigid orthodontic wire will be used to splint the tooth to the mesial and distal adjacent teeth

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Attachment Level
Time Frame: through study completion, an average of 1 year
measured as the distance in mm from the CEJ to the bottom of the pocket will be the primary outcome of this study.
through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Radiographic bone level
Time Frame: through study completion, an average of 1 year
Changes in marginal bone levels (MBLs), measured as the change in interproximal bone levels between 4 weeks after autotransplantation, six months and one year postoperatively. MBLs are defined as the distance between the cementoenamel junction (CEJ) and to the crestal bone level at the mesial and distal aspect . These measurements will also be recorded at the adjacent teeth/implants. For standardization of the radiographic technique, a customized bite block will be constructed for each patient using a parallel technique X-ray film holder (i.e.Rinn System, x-ray system or similar) and heavy silicone. The obtained digital radiographs will be evaluated using the image software (OsiriX Imaging Software, Geneva, Switzerland), with previous calibration of the images by inserting a small metal object of known measures in the bite block
through study completion, an average of 1 year
Digital image assessment. Position of the Alveolar Ridge Measurements
Time Frame: at the study completion. an average of 1 year
For each patient, the baseline and the last follow-up visit STL files and Digital Imaging and Communications in Medicine (DICOM) files will be superimposed for best-fit alignment. Alveolar ridge width changes will also be evaluated at the buccal and lingual mesial, mid, and distal sites. A sagittal section at each area of interest will be made. Horizontal alveolar ridge width linear changes will be quantified in mm at three predetermined reference points established at 1, 3, and 5mm from the baseline gingival margin.
at the study completion. an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Complutense de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ATT_EMD_RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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