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NCT Number: NCT05937100

New Vital Pulpotomy Medications in Primary Molars

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Carious Exposure of Pulp

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dentistry

Al Mansurah, 35511, Egypt

About this study

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:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • -Clinical criteria
  • Restorable mandibular primary molars with deep carious lesions.
  • Absence of gingival swelling or sinus tract.
  • Absence of spontaneous pain
  • Absence of pain on percussion. B-Radiographic Criteria: Absence of

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  • Discontinuity of lamina dura
  • Internal root resorption.
  • External root resorption.
  • inter-radicular or periapical bone destruction (radiolucency)

Exclusion criteria

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

Treatment and study plan

Formocresol

Drug

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

Biodentine

Drug

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

Hyaluronic Acid gel

Drug

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.

Primary outcomes

  1. clinically successful pulpotomy

    Time frame: 18 months

    • Pain symptom - free teeth on percussion as well as during mastication.
    • Absence of pathological tooth mobility.
    • Absence of swelling of pulpal origin.
    • . Absence of sinus tract.

  2. radiographically successful pulpotomy

    Time frame: 18 months

    • No internal or external root resorption.
    • No periapical or furcation radiolucency.
    • No widening of periodontal ligament space.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2023
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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