Emdogain Adjunctive to Autotransplantation

Phase 4

Recruiting

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

• Registration Number: NCT06250088
• Lead Sponsor: Universidad Complutense de Madrid

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-01-31
• Study First Posted: 2024-02-08
• Study Start: 2024-03-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09
• Primary Completion: 2025-06-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Emdogain (EMD)	Emdogain (EMD) - test	-
Emdogain (EMD)	Sham group	-
Control	Sham group	-

Primary Outcome Measures

Name	Time	Method
Clinical Attachment Level	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.

Secondary Outcome Measures

Name	Time	Method
Digital image assessment. Position of the Alveolar Ridge Measurements	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.
Radiographic bone level	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

Trial Locations

Locations (1)

Universidad Complutense de Madrid; 🇪🇸 Madrid, Spain