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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-7
SponsorCairo University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Children with a physical disability or medical disability.

Unrestorable molars.

Uncooperative patient.

Parent unable to attend Follow- up visits.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • MTA-Anglus

    Other intervention

    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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Group 1 (Potassium Nitrate in Polycarboxylate cement)Experimental treatment 1 intervention
Group B: Group 2 (Mineral Trioxide Aggregates "MTA")Active comparator 1 intervention

Trial outcomes

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).

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

Secondary outcomes

1

Radiographic success rate

1. Absence of external and internal root resorption: will be recorded by using intraoral digital periapical X Ray. 2. Absence of any pulp stones: will be recorded by using intraoral digital periapical X Ray. 3. Absence of any furcation and periapical radiolucency: will be recorded by using intraoral digital periapical X Ray. 4. Absence of any widening in periodontal ligament space: will be recorded by using intraoral digital periapical X Ray.

Time frame
Baseline, 3 month, 6 and 12 months after treatment

Other outcomes

Sponsors and contacts

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Cairo University

Lead sponsor

National Research Centre, Egypt

Collaborator

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