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Clinical and Radiographic Evaluation of Potassium Nitrate in Polycarboxylate Versus Mineral Trioxide Aggregate in Vital Pulpotomy in Primary Molars

NCT06871709 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-03-12

No results posted yet for this study

Summary

The purpose of this RCT is to compare the clinical/radiographic outcomes of Potassium nitrate in polycarboxylate cement and MTA as pulpotomy biomaterials used for asymptomatic vital primary lower second molar and this will help to clinically evaluate the use of alternative material in vital pulpotomy in primary molars with deep carious cavities.

Emphasis is set on avoiding total pupectomy and maintaining radicular pulp vitality therefore maintain the tooth in a viable condition till it's shedding and eruption of the permanent successor.

Conditions

  • Vital Pulp Therapies
  • Pulpotomy
  • Pulp Disease, Dental
  • Pulpotomies Primary Teeth
  • Pulp Therapy

Interventions

COMBINATION_PRODUCT

Potassium Nitrate in Polycarboxylate cement

The application of polycarboxylate cement containing 5% KNO3 for direct capping of traumatically exposed pulp in animal models did not result in any degenerative changes in dental pulp, thought creating optimal conditions for preservation of pulp vitality. Polycarboxylate cement has very thin film thickness and bonds firmly to the tooth structure, is capable of withstanding the overlying pressure during restoration procedures. The good adhesive properties of polycarboxylate cement containing 5% KNO3 guaranteed the closure of cavity, good and lasting protection of traumatically exposed dental pulp and the formation of alkaline environment possessing a strong antiacidic, anti-inflammatory and antibacterial effect of this pulp capping material, creating optimal conditions for expression of its natural reparative potential. The increased release of potassium nitrate from polycarboxylate cement by time, might be the cause of decreasing the inflammatory intensity

OTHER

MTA-Anglus

Mineral Trioxide Aggregate (MTA) has been the gold standard material for primary tooth pulpotomy. MTA has antimicrobial properties, excellent sealing ability, is biocompatible and has a dentinogenic effect on pulp tissue by stimulating the release of cytokines from bone cells, which promotes hard tissue formation. Furthermore, MTA maintains pulp tissue integrity while having no cytotoxic effects. Nevertheless, the clinical application of MTA has been limited due to some properties such as its long setting time, difficulty in its handling, being washed out, discoloration, and increased cost. These urged the search for an alternative pulpotomy material to MTA

Sponsors & Collaborators

  • National Research Centre, Egypt

    collaborator OTHER

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-30
Primary Completion
2026-01-01
Completion
2026-12-30

Countries

  • Egypt

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 NCT06871709 on ClinicalTrials.gov