Autotransplantation and Enamel Matrix Derivatives Case Series (ATTCS)

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

Study Overview

• Status: Completed
• Conditions: Tooth Loss
• Intervention / Treatment: Procedure: ATT + EMD

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28003
    • Universidad Complutense de Madrid
  • Madrid, Spain
    • Universidad Complutense Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ATT + EMD; There is only 1 arm, autotransplantation (ATT) + adjunctive EMD

Procedure: ATT + EMD; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level (CAL)	CAL level changes on the donor tooth between the baseline situation and the last follow up visit.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Investigators: Principal Investigator: Ignacio Pedrinaci, DDS, Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Estimated): February 15, 2024

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: enamel matrix derivatives; emdogain; tooth autotransplantation; tooth autogenous transplantation; digital planning
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: ATT_CS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No