Emdogain Adjunctive to Autotransplantation

Autologous Transplantation Clinical Trial

— ATTEMD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06250088
• Other study ID #: ATT_EMD_RCT
• Status: Recruiting
• Phase: Phase 4
• Start date: March 12, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: May 2024
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autologous Transplantation
• Emdogain

Intervention

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

Locations

Country	Name	City	State
Spain	Universidad Complutense de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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