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Completed

NCT Number: NCT06261255

Autotransplantation and Enamel Matrix Derivatives Case Series

The goal of this prospective case series 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 is:

- What is the benefit, in terms of clinical attachment level, of using enamel matrix derivatives adjunctive to tooth autotransplantation?

Participants will be subjected to a digitally protocol of tooth autotransplantation.Only one group (test) is assessed. It will be supplemented with the application of enamel matrix derivatives before the placement of the transplanted tooth into the surgically produced alveolus.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Complutense Madrid, Madrid, Spain

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About this study

All surgical treatments will be performed by the same experienced periodontist (IP) after the administration of local anesthesia. Initially, tooth sectioning of the hopeless tooth (receptor) will be carried out using fissure carbide burs, and the remaining fragments will be extracted as minimally invasively as possible. A tooth-supported surgical guide will be used to prepare the recipient site following the 3D planning. Additional alveoloplasty procedures will be performed with round diamond burs if necessary to adapt the computed aid 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 osteotomy is required, and avoiding the use of elevators or forceps over the root surface. Extraorally, EMD will be applied to the root surface of the donor tooth.

After positioning the donor tooth onto the surgically created recipient bed, a semi-rigid orthodontic wire will be used to splint the tooth to the mesial and distal adjacent teeth, and sutures will be applied to closely adapt the soft tissues around the autotransplanted tooth. Occlusal adjustments will be made if necessary. Alternatively, orthodontic composite bite stops will be placed on top of adjacent teeth to obtain temporary dental disocclusion.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults (≥18 years old) capable of providing informed consent, teeth deemed unrestorable and 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
  • 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

Treatment and study plan

ATT + EMD

Procedure

All surgical treatments will be performed by the same experienced periodontist (IP) after the administration of local anesthesia. Initially, tooth sectioning of the hopeless tooth (receptor) will be carried out using fissure carbide burs, and the remaining fragments will be extracted as minimally invasively as possible. A tooth-supported surgical guide will be used to prepare the recipient site following the 3D planning. Additional alveoloplasty procedures will be performed with round diamond burs if necessary to adapt the CARP model to the virtual planning position. The donor tooth will be extracted as atraumatically as possible, utilizing a piezoelectric surgical instrument if osteotomy is required, and avoiding the use of elevators or forceps over the root surface. Extraorally, EMD will be applied to the root surface of the donor tooth

Primary outcomes

  1. Clinical attachment level (CAL)

    Time frame: through study completion, an average of 1 year

    CAL level changes on the donor tooth between the baseline situation and the last follow up visit.

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

Efficacy of Digitally Tooth Autotransplantation With Adjunctive Use of Enamel Matrix Derivatives (EMD): A Prospective Case Series

Acronym: ATTCS

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2024
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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