NCT03493321

Brief Summary

this research will evaluate the effect of PRF with different bioactive materials in dentistry

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
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

March 12, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
1.4 years until next milestone

Study Start

First participant enrolled

August 22, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

Same day

First QC Date

March 12, 2018

Last Update Submit

August 19, 2019

Conditions

Neuritis

Outcome Measures

Primary Outcomes (1)

  • pain after the process

    Questionnaire by asking the patient about the pain intensity

    1 year

Secondary Outcomes (2)

  • dentin bridge formation

    1 year

  • no periapical radiolucency

    1 year

Study Arms (1)

PRF with MTA

EXPERIMENTAL

PRF with MTA with PRF with Theracal as intervention

Other: PRF with Theracal

Interventions

PRF with TheracalOTHER

using the PRF which is a new technique with an bioactive material which is the Theracal to evaluate its effect upon the radicular pulp tissue

PRF with MTA

Eligibility Criteria

Age16 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients suffering from Symptomatic pulpitis.
  • Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
  • Patients who will agree to the consent and will commit to follow-up period.
  • Patients with mature root.
  • Patients with no periapical lesion.
  • Patients with localized pain.
  • Posterior teeth only will be involved

You may not qualify if:

  • Patients with immature roots.
  • Patients with any systemic disease that may affect normal healing.
  • Patients with periapical lesions or infections.
  • Pregnant females.
  • Patients who could/would not participate in a 1-year follow-up.
  • Patients with fistula.
  • Patients with necrotic pulp.
  • Patients with old age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neuritis

Interventions

Prolactin-Releasing HormoneTheraCal

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Hypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

March 12, 2018

First Posted

April 10, 2018

Study Start

August 22, 2019

Primary Completion

August 22, 2019

Study Completion

September 30, 2019

Last Updated

August 20, 2019

Record last verified: 2019-08