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

Role of PRF With MTA and Theracal After Pulpotomy in Relieving Pain and Maintaining the Vitality of the Remaining Radicular Pulp Tissue in Permanent Posterior Teeth With Closed Root Apices: "Randomized Controlled Trial"

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

Study Overview

• Status: Unknown
• Conditions: Neuritis
• Intervention / Treatment: Other: PRF with Theracal

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.

• Study Type: Interventional
• Enrollment (Anticipated): 98
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRF with MTA; PRF with MTA with PRF with Theracal as intervention	Other: PRF 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 22, 2019
• Primary Completion (Anticipated): August 22, 2019
• Study Completion (Anticipated): September 30, 2019

Study Registration Dates

• First Submitted: March 12, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (Actual): April 10, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuritis
• Other Study ID Numbers: CEBD-CU-2018-03-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No