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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Indirect Pulp Capping in Children With Different Materials

Conditions
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Dental Pulp Capping

Intervention / Treatment
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* Drug: Calcium Hydroxide
* Drug: Mineral Trioxide Aggregate
* Drug: TheraCal LC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Calcium Hydroxide (Dycal)<br>Indirect pulp capping treatment with Calcium Hydroxide | Drug: Calcium Hydroxide<br>* After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity and restoration was finished in the same session.<br>* Other names: Pulp capping agent;Drug: Mineral Trioxide Aggregate<br>* After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity and restoration was finished in in the same session.<br>* Other names: (ProRoot MTA);Drug: TheraCal LC<br>* After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity (2 milimeter layer) and polymerized and restoration was finished in in the same session.<br>* Other names: resin-based calcium silicate cement;|
| Experimental: Mineral Trioxide Aggregate (ProRoot MTA)<br>Indirect pulp capping treatment with Mineral Trioxide Aggregate | Drug: Calcium Hydroxide<br>* After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity and restoration was finished in the same session.<br>* Other names: Pulp capping agent;Drug: Mineral Trioxide Aggregate<br>* After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity and restoration was finished in in the same session.<br>* Other names: (ProRoot MTA);Drug: TheraCal LC<br>* After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity (2 milimeter layer) and polymerized and restoration was finished in in the same session.<br>* Other names: resin-based calcium silicate cement;|
| Experimental: Theracal LC<br>Indirect pulp capping treatment with Theracal LC | Drug: Calcium Hydroxide<br>* After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity and restoration was finished in the same session.<br>* Other names: Pulp capping agent;Drug: Mineral Trioxide Aggregate<br>* After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity and restoration was finished in in the same session.<br>* Other names: (ProRoot MTA);Drug: TheraCal LC<br>* After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity (2 milimeter layer) and polymerized and restoration was finished in in the same session.<br>* Other names: resin-based calcium silicate cement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success rates of the indirect pulp capping biomaterials | No pathological symptom like abscess, fistulas or pain at percussion | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rates according to Modified USPHS criterias | No failed restorations during the controls | 24 months | 
| Radiographical success rates of the indirect pulp capping biomaterials | No radiolucency or root resorption, healing with dentin bridge | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Pulp, calcium hydroxide, Dental Pulp Capping