NCT04330768

Brief Summary

platelet rich fibrin(PRF) obtained from patient from patient blood sample (before start of treatment)is injected in the site of exposure of exposure(intervention group) control group will receive normal pulp capping procedure by MTA follow up will be one year

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

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

March 30, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

April 2, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 30, 2020

Last Update Submit

March 31, 2020

Conditions

Dental Pulp ExposureDental Caries

Outcome Measures

Primary Outcomes (1)

  • pulp vitality

    no sign of irreversible pulpitis or pulpal necrosis

    After 1 year

Study Arms (2)

PRF

EXPERIMENTAL
Procedure: PRF pulp capping

MTA

ACTIVE COMPARATOR
Procedure: MTA pulp capping

Interventions

PRF pulp cappingPROCEDURE

PRF is injected in the site of exposure

PRF
MTA pulp cappingPROCEDURE

conventional pulp capping procedure

MTA

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • deep carious lesion- no sign of irreversible pulpitis

You may not qualify if:

  • old age- periapical lesion-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental Pulp ExposureDental Caries

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesTooth Demineralization

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer at conservative department

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 1, 2020

Study Start

March 1, 2021

Primary Completion

March 1, 2022

Study Completion

June 1, 2022

Last Updated

April 2, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share