Autotransplantation and Enamel Matrix Derivatives Case Series

NCT06261255 | Completed

• 1 other identifier: ATT_CS
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Tooth Loss

Keywords

emdogain; enamel matrix derivatives; tooth autotransplantation; tooth autogenous transplantation; digital planning

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

ATT + EMD

EXPERIMENTAL

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

Procedure: ATT + EMD

Interventions

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

ATT + EMD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (2)

Universidad Complutense de Madrid

Madrid, 28003, Spain

Location

Universidad Complutense Madrid

Madrid, Spain

Location

MeSH Terms

Conditions

Tooth Loss

Interventions

emerin

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Ignacio Pedrinaci, DDS

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Principal investigator

Model Details: This clinical investigation is a single-center, prospective case series study and is reported in compliance with the Preferred Reporting of Case Series in Surgery (PROCESS) guidelines. The study was conducted at the Department of Periodontology of the University Complutense of Madrid between March 2021 and September 2023.

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 15, 2024
• Study Start: June 1, 2020
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)