Clinical and Radiographic Evaluation of Indirect Pulp Capping in Primary and Permanent Teeth With Different Materials
- Conditions
- Dental Pulp Capping
- Interventions
- Registration Number
- NCT03606681
- Lead Sponsor
- Altinbas University
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- teeth with clinical and radiographical indications of indirect pulp capping
- systemically healthy and cooperative children
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Calcium Hydroxide (Dycal) Calcium Hydroxide Indirect pulp capping treatment with Calcium Hydroxide Mineral Trioxide Aggregate (ProRoot MTA) Calcium Hydroxide Indirect pulp capping treatment with Mineral Trioxide Aggregate Theracal LC Calcium Hydroxide Indirect pulp capping treatment with Theracal LC Calcium Hydroxide (Dycal) Mineral Trioxide Aggregate Indirect pulp capping treatment with Calcium Hydroxide Calcium Hydroxide (Dycal) TheraCal LC Indirect pulp capping treatment with Calcium Hydroxide Mineral Trioxide Aggregate (ProRoot MTA) Mineral Trioxide Aggregate Indirect pulp capping treatment with Mineral Trioxide Aggregate Theracal LC Mineral Trioxide Aggregate Indirect pulp capping treatment with Theracal LC Mineral Trioxide Aggregate (ProRoot MTA) TheraCal LC Indirect pulp capping treatment with Mineral Trioxide Aggregate Theracal LC TheraCal LC Indirect pulp capping treatment with Theracal LC
- Primary Outcome Measures
Name Time Method Clinical success rates of the indirect pulp capping biomaterials 24 months No pathological symptom like abscess, fistulas or pain at percussion
- Secondary Outcome Measures
Name Time Method Success rates according to Modified USPHS criterias 24 months No failed restorations during the controls
Radiographical success rates of the indirect pulp capping biomaterials 24 months No radiolucency or root resorption, healing with dentin bridge