Emdogain Adjunctive to Autotransplantation (ATTEMD)

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: Recruiting
• Conditions: Autologous Transplantation; Emdogain; Autotransplantation; Enamel Matrix Derivatives
• Intervention / Treatment: Biological: Emdogain (EMD) - test; Procedure: Sham group

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28003
    • Recruiting
    • Universidad Complutense de Madrid
    • Contact: Ignacio Pedrinaci; Phone Number: +34 656257658; Email: ipedrinaci@gmail.com
    • Principal Investigator: Ignacio Pedrinaci

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Clinical Attachment Level	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

Outcome Measure	Measure Description	Time Frame
Radiographic bone level	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	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

• Sponsor: Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Emdogain and tooth autotransplantation
• Other Study ID 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