Back to resultsRole of PRF With MTA and Theracal After Pulpotomy in Relieving Pain
Primary Purpose
Neuritis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PRF with Theracal
Sponsored by
About this trial
This is an interventional treatment trial for Neuritis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PRF with MTA
Arm Description
PRF with MTA with PRF with Theracal as intervention
Outcomes
Primary Outcome Measures
pain after the process
Questionnaire by asking the patient about the pain intensity
Secondary Outcome Measures
dentin bridge formation
X-ray
no periapical radiolucency
X-ray
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03493321
Brief Title
Role of PRF With MTA and Theracal After Pulpotomy in Relieving Pain
Official Title
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"
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 22, 2019 (Anticipated)
Primary Completion Date
August 22, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
98 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRF with MTA
Arm Type
Experimental
Arm Description
PRF with MTA with PRF with Theracal as intervention
Intervention Type
Other
Intervention Name(s)
PRF with Theracal
Intervention Description
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
Primary Outcome Measure Information:
Title
pain after the process
Description
Questionnaire by asking the patient about the pain intensity
Time Frame
1 year
Secondary Outcome Measure Information:
Title
dentin bridge formation
Description
X-ray
Time Frame
1 year
Title
no periapical radiolucency
Description
X-ray
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
12. IPD Sharing Statement
Learn more about this trial
Role of PRF With MTA and Theracal After Pulpotomy in Relieving Pain
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