Clinical and Radiographic Assessment of Nano-Bioactive Glass Combined With I-PRF Scaffold in Vital Pulp Treatments in Mandibular Molars With Closed Apices (I-PRF)

May 24, 2023 updated by: Noor Mohammed Kamal Eldeen Ahmed Mohmammed Sayed, Cairo University

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"

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Total pulpotomy with I-PRF only
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
Procedure: Total pulpotomy with I-prf mixed with Nano-bioactive glass
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical , Radiographic and Success rate
Time Frame: 6 month follow up
Presence or absence of clinical signs and symptoms + Radiographic periapical assessment + success rate based on Radiographic findings
6 month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Within the first 24 hrs upto the 7th day
VAS used to record daily pain intensity
Within the first 24 hrs upto the 7th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Geraldine Ahmed, Vice Dean of Faculty of Dentistry Cairo University
  • Study Chair: Ahmed S. Elsheshtawy, Lecturer of Endodontics
  • Study Chair: Ayah Abdolwahab, Lecturer of Biomaterials
  • Principal Investigator: Noor K. Sayed, Resident of Endodontics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDO-3-7-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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