NCT02915419

Brief Summary

This study aims to compare the ability of different regenerative protocols in the treatment of mature necrotic

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

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

September 20, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

September 20, 2016

Last Update Submit

September 23, 2016

Conditions

Carious Teeth

Outcome Measures

Primary Outcomes (1)

  • Survival

    how long will the tooth survive after treatment, testing the durability of tooth

    1 year

Secondary Outcomes (2)

  • healing

    1 year

  • vitality

    1 year

Other Outcomes (1)

  • sensitivity

    1 year

Study Arms (2)

group A

ACTIVE COMPARATOR

prp revascularization

Biological: PRPBiological: PRF

group B

EXPERIMENTAL

treatment of affected teeth using platelet rich fibrin by applying prf in steril root canal

Biological: PRPBiological: PRF

Interventions

PRPBIOLOGICAL

platelet rich plasma

group Agroup B
PRFBIOLOGICAL

PLATELET RICH FIBRIN

group Agroup B

Eligibility Criteria

Age15 Years - 60 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 second premolar
  • Patients having non-vital, mature, second premolar teeth, radiographic evidence of periapical lesion.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wang Y, Zhu X, Zhang C. Pulp Revascularization on Permanent Teeth with Open Apices in a Middle-aged Patient. J Endod. 2015 Sep;41(9):1571-5. doi: 10.1016/j.joen.2015.04.022. Epub 2015 Jun 10.

    PMID: 26071100BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • wagih ali, ass lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

wagih ali, ass.lecturer

CONTACT

00201065550505wagihtarek.a@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

September 20, 2016

First Posted

September 27, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2018

Last Updated

September 27, 2016

Record last verified: 2016-09