Using Emdogain to improve tooth autotransplantation outcomes
Efficacy of Enamel Matrix Derivatives Adjunctive to Closed-apex Teeth Autotransplantation A Randomized Clinical Trial
This study is testing if using Emdogain during tooth autotransplantation can help adults with certain dental issues heal better after surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad Complutense de Madrid Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06250088 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of enamel matrix derivatives, specifically Emdogain, as an adjunctive treatment during tooth autotransplantation. Participants will undergo digitally guided surgery for tooth autotransplantation, with one group receiving Emdogain before the placement of the transplanted tooth, while the control group will receive a sham treatment. The primary focus is to assess improvements in clinical attachment levels and probing depths post-surgery. The study is conducted at the Universidad Complutense de Madrid, targeting adults with specific dental conditions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a viable tooth suitable for autotransplantation and stable periodontal health.
Not a fit: Patients with significant clinical attachment loss, systemic diseases affecting therapy outcomes, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the success rates of tooth autotransplantation and improve patient outcomes.
How similar studies have performed: While the use of enamel matrix derivatives in dental procedures has been explored, this specific application in tooth autotransplantation is relatively novel.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Madrid
- Universidad Complutense de Madrid — Madrid, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.