Clinical and Radiographic Evaluation of Indirect Pulp Capping in Primary and Permanent Teeth With Different Materials

Altinbas University

Status: Completed

Conditions: Dental Pulp Capping

Treatments: Drug: Calcium Hydroxide; Drug: TheraCal LC; Drug: Mineral Trioxide Aggregate

Study type: Interventional

Funder types: Other

Identifiers

NCT03606681

35793

Details and patient eligibility

About

Indirect pulp capping (IPC) is a treatment that preserves pulp's vitality. Several materials have been used for this procedure. The aim of this study is to evaluate the radiographic and clinical outcomes of TheraCal LC (Bisco Inc., Schaumburg, IL, USA) and to compare it with mineral trioxide aggregate (MTA) (Pro Root MTA, Dentsply Tulsa, Johnson City, TN, USA) and calcium hydroxide [Ca(OH)2] (Dycal, Dentsply De Trey Konstanz, Germany) biomaterials in IPC treatment.

Full description

A total of 295 teeth, including second primary molars and first permanent molars with IPC indications from healthy and cooperative children between the ages of 4-15, were included in this study. Teeth were divided into three groups according to the materials used for pulp capping. Indirect pulp treatment was applied using Dycal for 91 teeth, ProRoot MTA for 89 teeth and TheraCal LC for 115 teeth. Primary molars were restored with the compomer material, and permanent molars were restored with the resin composite material. Restorations were evaluated with the Modified United States Public Health Service (modified USPHS) criteria. Clinical and radiographic findings were evaluated for 24 months at follow-up.

Enrollment: 300 patients

Sex: All

Ages: 4 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• teeth with clinical and radiographical indications of indirect pulp capping
• systemically healthy and cooperative children

Exclusion criteria

• teeth with contraindications of indirect pulp capping: Clinical Exclusion Criteria
• Pain (spontaneous and chronic)
• Fistula
• Acute pulpal inflammation
• Pain with percussion
• Pathologic mobility
• Abscess
• Devitality symptoms (negative response to thermal pulp test) Radiographic Exclusion Criteria
• Progression of caries lesion to pulp
• Perforation of pulp
• Intermittent or irregular lamina dura
• Expanded range of periodontal ligament
• Periapical radiolucency
• Internal and external resorption
• systemically unhealthy and uncooperative children

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Calcium Hydroxide (Dycal)

Active Comparator group

Description:

Indirect pulp capping treatment with Calcium Hydroxide

Treatment:

Drug: Mineral Trioxide Aggregate

Drug: TheraCal LC

Drug: Calcium Hydroxide

Mineral Trioxide Aggregate (ProRoot MTA)

Experimental group

Description:

Indirect pulp capping treatment with Mineral Trioxide Aggregate

Treatment:

Drug: Mineral Trioxide Aggregate

Drug: TheraCal LC

Drug: Calcium Hydroxide

Theracal LC

Experimental group

Description:

Indirect pulp capping treatment with Theracal LC

Treatment:

Drug: Mineral Trioxide Aggregate

Drug: TheraCal LC

Drug: Calcium Hydroxide