Clinical trial NCT06250088: Emdogain Adjunctive to Autotransplantation
Official title: Efficacy of Enamel Matrix Derivatives Adjunctive to Closed-apex Teeth Autotransplantation A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Autotransplantation
Emdogain
Autologous Transplantation
Enamel Matrix Derivatives
Keywords: Emdogain and tooth autotransplantation
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Clinical Attachment Level
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Radiographic bone level
timeFrame: through study completion, an average of 1 year
measure: Digital image assessment. Position of the Alveolar Ridge Measurements
timeFrame: at the study completion. an average of 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Complutense de Madrid
Study officials:
References: