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Evaluation of Hyaluronic Acid Pulpotomies in Primary Molars

NCT04115358 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2021-08-03

Study results available
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Summary

In this study, 120 primary molar teeth from healthy children aged between 5 and 9 and who apply to Marmara University Faculty of Dentistry, Department of Pediatric Dentistry will be subjected to pulpotomy treatments. After proper diagnosis of coronal pulpitis, the teeth will be assigned randomly to one of the 3 groups: 40 primary molars for formocresol (FC) pulpotomy treatments, 40 primary molars for ferric sulfate (FS) treatments and 40 primary molars for 0.5% hyaluronic acid gel (HA) pulpotomy treatments. The tooth decay will be removed, the pulp will be amputated from the chamber of the pulp with a sharp excavator and one of the medicament will be applied to the orifice of the root canals. The cavity will be sealed tight with zinc oxide cement, and the primary molars will be restored with a composite filling material or with a stainless steel crown (SSC). A single investigator will perform the procedure. The teeth will be followed clinically and radiographically at 1st, 3rd, 6th, 12th months.

Conditions

  • Pulpitis

Interventions

PROCEDURE

Hyaluronic acid: Gengigel teething

Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns and composite filling material.

PROCEDURE

Formocresol Buckley formula: Formacresol

Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns and composite filling material.

PROCEDURE

Ferric sulfate: ViscoStat

Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns and composite filling material.

Sponsors & Collaborators

  • Marmara University

    lead OTHER

Principal Investigators

  • Ali Mentes, Prof · Marmara University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2020-09-01
Completion
2020-10-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04115358 on ClinicalTrials.gov