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

Deep Caries Clinical Trial

— RCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04005872
• Other study ID #: Cairo U E
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: November 30, 2022

Study information

• Verified date: December 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 30, 2022
• Est. primary completion date: November 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deep Caries

Intervention

Drug:
• Nano Silver Fluoride
Nano silver fluoride (NSF) is a new material consisting of nano silver particles, chitosan and sodium fluoride. It is a bacteriostatic and bactericidal compound.
• Calcium hydroxide
Calcium hydroxide is a gold standard for indirect pulp capping which induces hard tissue.

Locations

Country	Name	City	State
Egypt	Heba Mohamed Refaat Fouad Genena	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spontaneous pain or pain on biting	By asking patient	12 months
Primary	Pain on percussion	By the back of mirror	12 months
Primary	Swelling	Clinical examination by operator	12 months
Primary	Mobility	Clinical examination by operator	12 months
Primary	Sinus or fistula tract	Clinical examination by operator	12 months
Secondary	Furcation or perapical radiolucency	Periapical radiograph	12 months
Secondary	External or internal root resorption	Periapical radiograph	12 months
Secondary	Widening periodontal membrane space	Periapical radiograph	12 months