NCT03725514

Brief Summary

The majority of articles present in literature concerning the enrollment of tissue engineering in the field of root canal treatment is concerned with the treatment of affected teeth with immature apex, after proper systematic search online, only 4 articles where found that are dealing with the treatment of teeth with mature apex. These 4 studies are case reports. None of these studies has been a randomized clinical trial, the gold standard of interventional trials resulting in the highest level of evidence that contributes effectively in the clinical decision-making process as to the best intervention for the patient's condition providing the most effective clinical outcomes for the satisfaction of the patient. Since that the triad of regenerative endodontics are the key of success of any attempt to regenerate pulp, 2 different maneuvers shall be done in this study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 28, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

2.9 years

First QC Date

October 28, 2018

Last Update Submit

October 3, 2020

Conditions

Regeneration

Outcome Measures

Primary Outcomes (1)

  • Change of tooth Sensitivity

    Electric Pulp Tester

    1, 3, 6, 9, 12 Months

Secondary Outcomes (4)

  • Survival

    1, 3, 6, 9, 12 Months

  • Clinical Success

    1, 3, 6, 9, 12 Months

  • Pericapical Status

    6, 9, 12 Months

  • Periapical Status

    1, 3, 6, 9, 12 Months

Study Arms (2)

conventional

ACTIVE COMPARATOR

Conventional blood clot technique

Procedure: Conventional

PRF

EXPERIMENTAL

Platelet Rich Fibrin Technique

Procedure: PRF

Interventions

ConventionalPROCEDURE

Conventional Blood Clot Technique

conventional
PRFPROCEDURE

Platelet Rich Fibrin Technique

PRF

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients who are free from any physical or mental handicapping condition with no underlying systemic diseases.
  • Non-pregnant females
  • Single canalled teeth.
  • Patients having vital, mature, single rooted teeth, clinical evidence of pulpitis and apical periodontitis.
  • Positive patient/Guardian compliance for participation in the study.

You may not qualify if:

  • Any known sensitivity or adverse reactions to medicaments or pharmaceuticals necessary to complete the trial.
  • Non-restorable coronal portion of teeth involved in the trial.
  • Non Vital teeth
  • Immature teeth
  • Traumatized teeth
  • Radiographic evidence of external or internal root resorption.
  • Single Rooted teeth with multiple canals.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

Related Publications (1)

  • Araujo PRS, Silva LB, Neto APDS, Almeida de Arruda JA, Alvares PR, Sobral APV, Junior SA, Leao JC, Braz da Silva R, Sampaio GC. Pulp Revascularization: A Literature Review. Open Dent J. 2017 Jan 31;10:48-56. doi: 10.2174/1874210601711010048. eCollection 2017.

    PMID: 28567136BACKGROUND

MeSH Terms

Interventions

Congresses as Topic

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Central Study Contacts

Mostafa O Fahim, MSc of Endodontics

CONTACT

+201112367773Mostafa.o.fahim@gmail.com

Alaa Baz, Ass. Prof Endodontics

CONTACT

01000826286alaa.elbaz@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Sealed Opaque Envelopes
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Endodontics

Study Record Dates

First Submitted

October 28, 2018

First Posted

October 31, 2018

Study Start

December 1, 2018

Primary Completion

October 30, 2021

Study Completion

December 30, 2021

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

Participant data will be made available

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
It will be available after finishing the study
Access Criteria
It will be uploaded on a folder on google drive to be accessed through this link URL: https://drive.google.com/open? id=1rZXDbSgsneWDO4xGz8KGkklEHHw2YYIX
More information

Locations

EG(1)