NCT05775081

Brief Summary

This study will be conducted to clinically evaluate the efficacy of human treated dentine matrix paste and Platelet rich fibrin (PRF) in induction of root formation of non-vital immature permanent teeth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

March 13, 2024

Status Verified

September 1, 2023

Enrollment Period

2.4 years

First QC Date

March 7, 2023

Last Update Submit

March 11, 2024

Conditions

Regenerative Endodontic ProceduresNecrotic Pulp

Keywords

Platelet rich fibrin, Treated dentine matrix

Outcome Measures

Primary Outcomes (1)

  • Clinical evaluation

    Clinically evaluating the efficacy of human treated dentine matrix paste and Platelet rich fibrin (PRF) in induction of root formation of non-vital immature permanent teeth.

    15 months

Secondary Outcomes (1)

  • Radiographic evaluation

    15 months

Study Arms (2)

Treated Dentine Matrix (TDM)

EXPERIMENTAL

Participants treated with TDM paste

Other: Regenerative endodontic procedues

Platelet Rich Fibrin (PRF)

EXPERIMENTAL

Participants treated with PRF

Other: Regenerative endodontic procedues

Interventions

Regenerative endodontic proceduesOTHER

Treating non-vital immature permanent teeth with either treated dentine matrix paste or platelet rich fibrin

Platelet Rich Fibrin (PRF)Treated Dentine Matrix (TDM)

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients aged from 6-11 years presenting with a non-vital permanent immature tooth.

You may not qualify if:

  • History of uncontrolled diabetes
  • Immunosuppression
  • Chronic systemic disease if a treatment is required
  • Periodontal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed A Asal, MDS

    Mansoura University

    PRINCIPAL INVESTIGATOR

  • Ibrahim H Elkalla, PhD

    Mansoura University

    STUDY CHAIR

  • Yousry M Elhawary, PhD

    Mansoura University

    STUDY DIRECTOR

  • Ashraf Y Alhsoainy, PhD

    Mansoura University

    STUDY DIRECTOR

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

March 7, 2023

First Posted

March 20, 2023

Study Start

July 15, 2021

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

March 13, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)