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

NCT06871709 | Not Yet Recruiting

• 1 other identifier: Vital Primary Molars Pulpotmy
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mineral Trioxide Aggregate; Potassium Nitrate; MTA; Pulpotomy; Vital Pulpotomy; Vital Pulp therapy; Primary Molars; pulp therapy; Pulp disease

Outcome Measures

Primary Outcomes (1)

• Clinical success rate

  1. Post-operative pain: will be recorded by verbal question to patient/ parent. 2. Soft tissue pathology: will be recorded by visual clinical examination. 3. Pain to percussion: will be recorded by percussion test (by the back of the dental mirror). 4. Pathological mobility: will be recorded by mobility test (pressure using the end of two dental mirrors).

  Baseline, 1 week, 3 month, 6, 9 and 12 months after treatment

Secondary Outcomes (1)

• Radiographic success rate

  Baseline, 3 month, 6 and 12 months after treatment

Study Arms (2)

Group 1 (Potassium Nitrate in Polycarboxylate cement)

EXPERIMENTAL

Potassium nitrate (KNO3) is a superior desensitizer for hypersensitive teeth. Used with polycarboxylate cement, it serves as an effective liner for deep carious lesions. Also when placed under deep restorations with less than 1 mm of protective dentin remaining, it was effective in preserving pulpal vitality and it diminished the incidence and severity of post-restoration pain. As temporary cement (Kno3/zinc oxide eugenol \[ZOE\]) It reduced pain following full crown preparation.

Combination Product: Potassium Nitrate in Polycarboxylate cement

Group 2 (Mineral Trioxide Aggregates "MTA")

ACTIVE COMPARATOR

Mineral trioxide aggregate (MTA) has been recommended as the gold standard for vital pulp therapy as it showed a high success rate clinically and radiographically when compared to other materials due to its biocompatibility, antibacterial properties and excellent sealing ability

Other: MTA-Anglus

Interventions

Potassium Nitrate in Polycarboxylate cement COMBINATION_PRODUCT

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

Group 1 (Potassium Nitrate in Polycarboxylate cement)

MTA-Anglus OTHER

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

Group 2 (Mineral Trioxide Aggregates "MTA")

Eligibility Criteria

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

You may qualify if:

• Children aged 4 to 7 years, in good general health.
• Children with vital, deeply carious primary molars.
• No history of spontaneous pain, pathological mobility, draining sinus tract, redness or swelling of the vestibule.
• Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test.
• No sign of radiolucency in periapical or furcation area.
• No widening of PDL space or loss of lamina dura continuity.
• No evidence of internal/external pathological root resorption.

You may not qualify if:

• Children with a physical disability or medical disability.
• Unrestorable molars.
• Uncooperative patient.
• Parent unable to attend Follow- up visits.
• Parents refuse to give written informed consent.
• If the access was opened and irreversible pulpitis was evident.

Sponsors & Collaborators

• Cairo University: lead
• National Research Centre, Egypt: collaborator

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

potassium nitrate; Polycarboxylate Cement

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Polycarbonates; Polymers; Macromolecular Substances; Dental Cements; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Mariam M El-Mosallamy, bachelor's degree in dentistry

CONTACT

+201066761063; mariamm.ahmoud@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 12, 2025
• Study Start: May 30, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)