Emdogain Adjunctive to Autotransplantation (ATTEMD)

Universidad Complutense de Madrid

Status and phase

Enrolling

Phase 4

Conditions

Emdogain

Autologous Transplantation

Autotransplantation

Enamel Matrix Derivatives

Treatments

Procedure: Sham group

Biological: Emdogain (EMD) - test

Study type

Interventional

Funder types

Other

Identifiers

NCT06250088

ATT_EMD_RCT

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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