Deep Caries
Conditions
Brief summary
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
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).
Interventions
Nano silver fluoride (NSF) is a new material consisting of nano silver particles, chitosan and sodium fluoride. It is a bacteriostatic and bactericidal compound.
DRUGCalcium hydroxide
Calcium hydroxide is a gold standard for indirect pulp capping which induces hard tissue.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Eligible consented participants will be randomly assigned to know which side of the participant (right or left) will be control or intervention group according to a sequence generated on a Microsoft Excel sheet where the intervention (I) and the control (C) are simply randomized.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sinus or fistula tract | 12 months | Clinical examination by operator |
| Pain on percussion | 12 months | By the back of mirror |
| Swelling | 12 months | Clinical examination by operator |
| Mobility | 12 months | Clinical examination by operator |
| Spontaneous pain or pain on biting | 12 months | By asking patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| External or internal root resorption | 12 months | Periapical radiograph |
| Widening periodontal membrane space | 12 months | Periapical radiograph |
| Furcation or perapical radiolucency | 12 months | Periapical radiograph |
Countries
Egypt
Outcome results
None listed