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Clinical Trials in Egypt / NCT06871709
Starting soon Not applicable

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

NCT06871709 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-05-30
Last updated
2025-03-12

Condition(s) studied

Vital Pulp TherapiesPulpotomyPulp Disease, DentalPulpotomies Primary TeethPulp Therapy

Investigational drug(s) / intervention(s)

Potassium Nitrate in Polycarboxylate cementMTA-Anglus

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

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

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.

Eligibility

Sex
ALL
Min age
4 Years
Max age
7 Years
Healthy volunteers
Accepted
❖ Inclusion Criteria: 1. Children aged 4 to 7 years, in good general health. 2. Children with vital, deeply carious primary molars. 3. No history of spontaneous pain, pathological mobility, draining sinus tract, redness or swelling of the vestibule. 4. Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test. 5. No sign of radiolucency in periapical or furcation area. 6. No widening of PDL space or loss of lamina dura continuity. 7. No evidence of internal/external pathological root resorption. Exclusion Criteria: 1. Children with a physical disability or medical disability. 2. Unrestorable molars. 3. Uncooperative patient. 4. Parent unable to attend Follow- up visits. 5. Parents refuse to give written informed consent. 6. If the access was opened and irreversible pulpitis was evident.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Cairo University Cairo Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06871709 on ClinicalTrials.gov ↗ ← All trials in Egypt