New Vital Pulpotomy Medications in Primary Molars

July 7, 2023 updated by: Weaam ibrahiem eltantawy, Mansoura University

Clinical and Radiographic Evaluation of Hyaluronic Acid and Biodentine as Vital Pulpotomy Medications in Primary Molars: Randomized Controlled Clinical Trial

Evaluate clinically and radiographically the effect of biodentine and hyaluronic acid (HA) versus formocresol (FC) as pulpotomy medications in primary molars.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Split mouth randomized controlled clinical trial. This study will be conducted on 96 teeth from 48 children in age group 4-7 years and have bilateral lower primary molars indicated for vital pulpotomy procedure. for:

  1. Clinical evaluation of biodentine, hyaluronic acid and formocresol groups according to presence of failure criteria at different follow up periods.
  2. Radiographic evaluation of biodentine, hyaluronic acid and formocresol groups according to presence of failure criteria at different follow up periods.

Study Type

Interventional

Enrollment (Estimated)

48

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 Locations

  • Egypt
      • Mansoura, Egypt, 35511
        • Dentistry

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • -Clinical criteria

    1. Restorable mandibular primary molars with deep carious lesions.
    2. Absence of gingival swelling or sinus tract.
    3. Absence of spontaneous pain
    4. Absence of pain on percussion. B-Radiographic Criteria: Absence of
    1. Discontinuity of lamina dura
    2. Internal root resorption.
    3. External root resorption.
    4. inter-radicular or periapical bone destruction (radiolucency)

Exclusion Criteria:

  1. Excessive bleeding during pulp amputation.
  2. Non vital/necrotic teeth.
  3. Any sort of medical history contraindicating the pulp treatment.
  4. Teeth approximate exfoliation
  5. Patient's guardians are not intending to be part of the study.
  6. Retreatment of previously pulpotomy treated molar -

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control: Formocresol
Teeth will be treated by using squeezed sterile cotton pellet with 20% formcresol for 1 minute then removed and pulp stumps will be dressed with a layer of zinc oxide-eugenol (ZOE) paste.
Drug: Formocresol
Molars will be anesthetized by local anesthesia. The rubber dam will be used for isolation. Caries will be removed by large spoon excavator. When pulpal exposure occurs, deroofing of the pulp chamber will be achieved then pulpal tissue will be amputated using sharp excavator. Hemostasis will be obtained by applying pressure with saline moist cotton pellet. If bleeding has not stopped within 5 min, tooth will be excluded from the study.Teeth will be treated by using squeezed sterile cotton pellet with 20% formcresol for 1 minute
Experimental: Group A : (Biodentine)
The biodentine mix will be prepared according to the manufacturer's instructions and condensed lightly with a condenser on the pulp stumps, and allowed to set.
Drug: Biodentine
Molars will be anesthetized by local anesthesia. The rubber dam will be used for isolation. Caries will be removed by large spoon excavator. When pulpal exposure occurs, deroofing of the pulp chamber will be achieved then pulpal tissue will be amputated using sharp excavator. Hemostasis will be obtained by applying pressure with saline moist cotton pellet. If bleeding has not stopped within 5 min, tooth will be excluded from the study.The biodentine mix will be prepared according to the manufacturer's instructions and condensed lightly with a condenser on the pulp stumps
Experimental: Group B : (Hyaluronic acid gel)
Hyaluronic acid gel will be compressed against the amputated pulp for 5 minutes. Then the pulp stumps will be dressed with a layer of zinc oxide-eugenol (ZOE) paste.
Drug: Hyaluronic acid gel
Molars will be anesthetized by local anesthesia. The rubber dam will be used for isolation. Caries will be removed by large spoon excavator. When pulpal exposure occurs, deroofing of the pulp chamber will be achieved then pulpal tissue will be amputated using sharp excavator. Hemostasis will be obtained by applying pressure with saline moist cotton pellet. If bleeding has not stopped within 5 min, tooth will be excluded from the study.Hyaluronic acid gel will be compressed against the amputated pulp for 5 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinically successful pulpotomy
Time Frame: 18 months
  1. Pain symptom - free teeth on percussion as well as during mastication.
  2. Absence of pathological tooth mobility.
  3. Absence of swelling of pulpal origin.
  4. . Absence of sinus tract.
18 months
radiographically successful pulpotomy
Time Frame: 18 months
  1. No internal or external root resorption.
  2. No periapical or furcation radiolucency.
  3. No widening of periodontal ligament space.
18 months

Collaborators and Investigators

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

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Weaam I El-tantawy, assistant lecturer ,Faculty of Dentistry, Mansoura University B.D.S (2016)
  • Study Director: Nadia M Farrag, Professor ,Faculty of Dentistry, Mansoura University
  • Study Director: Hossam E Hammouda, Lecturer, Faculty of Dentistry, Mansoura University

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)

May 1, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

June 30, 2023

First Submitted That Met QC Criteria

July 7, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0103023PP

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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