Role of PRF With MTA and Theracal After Pulpotomy in Reli... | NCT03493321

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

NCT03493321

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Aug 20, 2019Actual

Enrollment

98Estimated

Phase

Not Applicable

Conditions

Neuritis

Interventions

PRF with Theracal

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 22, 2019Estimated

Primary Completion Date

Aug 22, 2019Estimated

Completion Date

Sep 30, 2019Estimated

First Submitted Date

Mar 12, 2018

First Submission Date that Met QC Criteria

Apr 3, 2018

First Posted Date

Apr 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2019

Last Update Posted Date

Aug 20, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

98Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PRF with MTA	Experimental	PRF with MTA with PRF with Theracal as intervention	Other: PRF with Theracal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PRF with Theracal	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain after the process	Questionnaire by asking the patient about the pain intensity	1 year

Secondary Outcomes

Measure	Description	Time Frame
dentin bridge formation	X-ray	1 year
no periapical radiolucency	X-ray	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

35 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009443	Neuritis

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D056690	Prolactin-Releasing Hormone
C000632580	TheraCal

Ancestor Terms

ID	Term
D007028	Hypothalamic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

Not provided

Browse Branches

Not provided