New Vital Pulpotomy Medications in Primary Molars

NCT05937100 | Active Not Recruiting

• 1 other identifier: A0103023PP
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carious Exposure of Pulp

Keywords

Hyaluronic Acid - Biodentine - Pulpotomy

Outcome Measures

Primary Outcomes (2)

• clinically successful pulpotomy

  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

  1. No internal or external root resorption. 2. No periapical or furcation radiolucency. 3. No widening of periodontal ligament space.

  18 months

Study Arms (3)

control: Formocresol

ACTIVE COMPARATOR

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

Group A : (Biodentine)

EXPERIMENTAL

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

Group B : (Hyaluronic acid gel)

EXPERIMENTAL

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

Interventions

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

control: Formocresol

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

Group A : (Biodentine)

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.

Group B : (Hyaluronic acid gel)

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Dentistry

Al Mansurah, 35511, Egypt

Location

MeSH Terms

Interventions

formocresol; tricalcium silicate

Study Officials

• Weaam I El-tantawy

  assistant lecturer ,Faculty of Dentistry, Mansoura University B.D.S (2016)

  PRINCIPAL INVESTIGATOR

• Nadia M Farrag

  Professor ,Faculty of Dentistry, Mansoura University

  STUDY DIRECTOR

• Hossam E Hammouda

  Lecturer, Faculty of Dentistry, Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: the observer and the recipients will be blinded to the study group to avoid bias (double blind randomized controlled trial)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer at pediatric department-Mansoura University

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 10, 2023
• Study Start: May 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

EG (1)