Clinical and Radiographic Evaluation of Nano Silver Fluoride Versus Calcium Hydroxide in Indirect Pulp Treatment

Study Overview
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Brief Summary
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The management of deep carious lesions approaching a healthy pulp is considered a challenge to the dental practitioner. The conventional treatment of deep carious lesions requires the removal of all infected and affected dentin to avoid more cariogenic activity.

Detailed Description
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This study is designed to assess the clinical and radiographic effectivness of nano silver fluoride versus calcium hydroxide in an indirect pulp treatment of deep carious second primary molars. This clinical study is important because World Health Organization (WHO) has reported that school children experience to dental caries was 60-90% of worldwide (P. D. Garkoti et al., 2015). This clinical trial has potential benefits to patients where indirect pulp treatment preserves pulp vitality by partial caries removal without exposing pulp. Several materials have been used for indirect pulp technique including calcium hydroxide (Metalita M et al., 2016).

Official Title
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Clinical and Radiographic Evaluation of Nano Silver Fluoride Versus Calcium Hydroxide in Indirect Pulp Treatment of Deep Carious Second Primary Molars, Randomized Clinical Trial

Conditions
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Deep Caries

Intervention / Treatment
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* Drug: Nano Silver Fluoride
* Drug: Calcium hydroxide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients: Cooperative children. Both genders. In age range from 4 to 7 years. Teeth: Vital second primary molars with deep caries limited to occlusal surface. No clinical signs or symptoms of irreversible pulpitis or pulp necrosis. No radiographic abnormalities Restorable teeth. Exclusion Criteria: • Children with known history of allergy to any of the tested materials. Children with systemic conditions. Parents who refused to participate.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This clinical trial has potential benefits to patients where indirect pulp treatment preserves pulp vitality by partial caries removal without exposing pulp. Several materials have been used for indirect pulp technique including calcium hydroxide
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nano Silver Fluoride<br>2 drops of nano silver fluoride (NSF) applied on the last soft carious layer using micro brush | Drug: Nano Silver Fluoride<br>* Nano silver fluoride (NSF) is a new material consisting of nano silver particles, chitosan and sodium fluoride. It is a bacteriostatic and bactericidal compound.<br>* Other names: NSF;|
| Active Comparator: Calcium Hydroxide<br>Calcium hydroxide placed on the last soft carious layer approaching the pulp | Drug: Calcium hydroxide<br>* Calcium hydroxide is a gold standard for indirect pulp capping which induces hard tissue.<br>* Other names: CaoH;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous pain or pain on biting | By asking patient | 12 months | 
| Pain on percussion | By the back of mirror | 12 months | 
| Swelling | Clinical examination by operator | 12 months | 
| Mobility | Clinical examination by operator | 12 months | 
| Sinus or fistula tract | Clinical examination by operator | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Furcation or perapical radiolucency | Periapical radiograph | 12 months | 
| External or internal root resorption | Periapical radiograph | 12 months | 
| Widening periodontal membrane space | Periapical radiograph | 12 months |