Back to resultsClinical and Radiographic Assessment of Nano-Bioactive Glass Combined With I-PRF Scaffold in Vital Pulp Treatments in Mandibular Molars With Closed Apices (I-PRF)
Primary Purpose
Vital Pulp Treatment in Mature Permanent Teeth With Irreversible Pulpitis
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Total pulpotomy with I-prf mixed with Nano-bioactive glass
Sponsored by
About this trial
This is an interventional treatment trial for Vital Pulp Treatment in Mature Permanent Teeth With Irreversible Pulpitis
Eligibility Criteria
Inclusion Criteria: Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars only will be involved. Tooth should give positive response to cold test Haemostasias should be achieved after total pulpotomy The tooth is restorable and free from advanced periodontal disease, cracks and splits. 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 apices Patients with no internal or external resorption and no periapical lesions Soft tissues around the tooth are normal with no swelling or sinus tract. Exclusion Criteria: Patients with immature roots. Haemostasias after 10 minutes can not be controlled after total pulpotomy 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 6 months follow-up. Patients with fistula or swelling Patients with necrotic pulp. Patients with old age.
Sites / Locations
- Noor Mohammed Kamal EldeenRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Total pulpotomy with I-PRF only
Arm Description
Total pulpotomy is done in mature permanent molars followed by I-prf application. Topped with BC putty for coronal seal, RMGI and restored with composite as final restoration
Outcomes
Primary Outcome Measures
Clinical , Radiographic and Success rate
Presence or absence of clinical signs and symptoms + Radiographic periapical assessment + success rate based on Radiographic findings
Secondary Outcome Measures
Pain intensity
VAS used to record daily pain intensity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05876520
Brief Title
Clinical and Radiographic Assessment of Nano-Bioactive Glass Combined With I-PRF Scaffold in Vital Pulp Treatments in Mandibular Molars With Closed Apices
Acronym
I-PRF
Official Title
Clinical and Radiographic Assessment of Nano-Bioactive Glass Combined With I-PRF Scaffold in Vital Pulp Treatments in Mandibular Molars With Closed Apices: A Triple Blinded "Randomized Controlled Trial"
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
April 2024 (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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Clinical, Radiographic and pain assessment of Vital pulp treatment in patients suffering from irreversible pulpitis in mature permanent molars. Total pulpotomy is investigated using I-prf only vs I-prf mixed with Nano-bioactive glass.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vital Pulp Treatment in Mature Permanent Teeth With Irreversible Pulpitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Total Pulpotomy in mature permanent teeth treated with Nano-bioactive glass mixed with I-PRF
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Total pulpotomy with I-PRF only
Arm Type
Other
Arm Description
Total pulpotomy is done in mature permanent molars followed by I-prf application. Topped with BC putty for coronal seal, RMGI and restored with composite as final restoration
Intervention Type
Procedure
Intervention Name(s)
Total pulpotomy with I-prf mixed with Nano-bioactive glass
Intervention Description
Total pulpotomy is done in mature permanent molars followed by I-prf mixed with Nano-Bioactive glass application. Topped with BC putty for coronal seal, RMGI and restored with composite as final restoration
Primary Outcome Measure Information:
Title
Clinical , Radiographic and Success rate
Description
Presence or absence of clinical signs and symptoms + Radiographic periapical assessment + success rate based on Radiographic findings
Time Frame
6 month follow up
Secondary Outcome Measure Information:
Title
Pain intensity
Description
VAS used to record daily pain intensity
Time Frame
Within the first 24 hrs upto the 7th day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
32 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars only will be involved.
Tooth should give positive response to cold test
Haemostasias should be achieved after total pulpotomy
The tooth is restorable and free from advanced periodontal disease, cracks and splits.
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 apices
Patients with no internal or external resorption and no periapical lesions
Soft tissues around the tooth are normal with no swelling or sinus tract.
Exclusion Criteria:
Patients with immature roots.
Haemostasias after 10 minutes can not be controlled after total pulpotomy
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 6 months follow-up.
Patients with fistula or swelling
Patients with necrotic pulp.
Patients with old age.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noor K. Sayed
Phone
00201121818177
Email
noor.kamal@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Kamal K. Ahmed
Phone
0020 101 4147393
Email
noor.m.kamal35@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geraldine Ahmed
Organizational Affiliation
Vice Dean of Faculty of Dentistry Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed S. Elsheshtawy
Organizational Affiliation
Lecturer of Endodontics
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ayah Abdolwahab
Organizational Affiliation
Lecturer of Biomaterials
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Noor K. Sayed
Organizational Affiliation
Resident of Endodontics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Noor Mohammed Kamal Eldeen
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noor K. Sayed
Phone
00201121818177
Email
noor.kamal@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Noor K. Sayed
Phone
00201121818177
Email
noor.m.kamal35@gmail.com
First Name & Middle Initial & Last Name & Degree
Noor K. Sayed, BDS
12. IPD Sharing Statement
Learn more about this trial
Clinical and Radiographic Assessment of Nano-Bioactive Glass Combined With I-PRF Scaffold in Vital Pulp Treatments in Mandibular Molars With Closed Apices
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