NCT06553300

Brief Summary

Autotransplantation emerges as a viable alternative to tooth extraction and prosthetic restoration when conventional endodontic treatments are unfeasible or contraindicated. The success of autotransplantation is influenced by diverse factors, including root development stage, tooth morphology, surgical technique, extraoral duration, recipient socket shape, recipient bed vascularity, and periodontal ligament cell vitality. Preserving periodontal ligament quality and achieving tissue adaptation are pivotal for successful tooth transplantation. Successful donor tooth replacement is influenced by variables like fitting attempts, alveolus-root distance, extra-alveolar time, surgical skill, and extraction trauma intensity.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 14, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

August 14, 2024

Status Verified

July 1, 2024

Enrollment Period

10 months

First QC Date

July 29, 2024

Last Update Submit

August 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Radiographic success

    The success of auto-transplanted immature third molars with and without Platelet-Rich Fibrin will be assessed over a year period.

    one year

Study Arms (2)

Autotransplantation with PRF

EXPERIMENTAL
Procedure: Autotransplantation with PRF

Autotrasplantation only

ACTIVE COMPARATOR
Procedure: Autotransplatation Only

Interventions

Autotransplantation of Wisdom teeth to the extracted socket of removed broken down posterior teeth with the application of PRF

Autotransplantation with PRF

Autotransplantation of Wisdom teeth to the extracted socket of removed broken down posterior teeth.

Autotrasplantation only

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male and female
  • aged between 20 and 50 years
  • devoid of systemic ailments
  • complying with the study procedures
  • holding an Anesthesiologists classification of 1 or 2
  • possessing mandibular or maxillary immature wisdom teeth

You may not qualify if:

  • systemic diseases that might impede the healing process
  • Patients with pacemakers
  • Individuals harboring allergies to medications or antibiotics
  • active smokers
  • patients afflicted with periodontal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Dental Institute

Cleveland, Ohio, 44128, United States

RECRUITING

MeSH Terms

Interventions

Transplantation, AutologousProlactin-Releasing Hormone

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, OperativeHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Waleed Elmallah, DDS

    Cleveland Dental

    STUDY CHAIR
  • Ahmed Hashem, DDS

    Cleveland Dental

    STUDY DIRECTOR

Central Study Contacts

Luis M De la Rosa, DDS

CONTACT

Nelza Baladi, DDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2024

First Posted

August 14, 2024

Study Start

January 1, 2024

Primary Completion

October 31, 2024

Study Completion

March 31, 2025

Last Updated

August 14, 2024

Record last verified: 2024-07

Locations