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Status unknownNCT03493321Updated Aug 20, 2019

Role of PRF With MTA and Theracal After Pulpotomy in Relieving Pain

An interventional study of PRF with Theracal in Neuritis, sponsored by Cairo University. Status unknown. Open to participants aged 16 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-20.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
98
Allocation
Not applicable
Ages
16 Years to 35 Years
Sex
All
01

Study summary

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

Read the detailed description

PRF will be used with MTA and Theracal to evaluate its effect upon these materials in reliving pain and maintains the teeth vitality in permanent teeth with closed apices, in order to improve the materials outcome.

02

Conditions studied

  • Neuritis

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03

In context

Neuritis

73 studies on the registry are indexed under Neuritis; 20 are open to participants now.

This study's planned enrollment of 98 is above the median of 48 across 51 interventional studies indexed under Neuritis.

Browse Neuritis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,457 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Browse Cairo University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
98 participants (estimated)

Study arms

  • Experimental
    PRF with MTA

    PRF with MTA with PRF with Theracal as intervention

    Other: PRF with Theracal

Interventions

  • OtherPRF with Theracal

    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

06

What researchers measure

Primary outcomes

  1. pain after the process

    Questionnaire by asking the patient about the pain intensity

    Time frame: 1 year

Secondary outcomes

  1. dentin bridge formation

    X-ray

    Time frame: 1 year

  2. no periapical radiolucency

    X-ray

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2019; primary completion for Aug 2019, 0 months later.

Of 23 interventional studies with no phase under Neuritis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 31. This study's planned 0 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 12, 2018
First posted
Apr 10, 2018
StartEst.
Aug 22, 2019
Primary completionEst.
Aug 22, 2019
CompletionEst.
Sep 30, 2019
Last update
Aug 20, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03493321
Lead sponsor
Cairo University
Responsible party
Sarah Essam (Principle investigator, Cairo University) — Principal investigator
First posted
Apr 10, 2018
Start date
Aug 22, 2019 (estimated)
Primary completion
Aug 22, 2019 (estimated)
Completion
Sep 30, 2019 (estimated)
Last update
Aug 20, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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