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

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

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.

Study Overview

• Status: Completed
• Conditions: Deep Caries
• Intervention / Treatment: Drug: Nano Silver Fluoride; Drug: Calcium hydroxide

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).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Heba Mohamed Refaat Fouad Genena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nano Silver Fluoride; 2 drops of nano silver fluoride (NSF) applied on the last soft carious layer using micro brush	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.; Other Names: NSF
Active Comparator: Calcium Hydroxide; Calcium hydroxide placed on the last soft carious layer approaching the pulp	Drug: Calcium hydroxide; Calcium hydroxide is a gold standard for indirect pulp capping which induces hard tissue.; Other Names: CaoH

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): November 5, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Estimate): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 18, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Calcium-Regulating Hormones and Agents; Cariostatic Agents; Calcium; Fluorides
• Other Study ID Numbers: Cairo U E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Clinical and Radiographic Evaluation of Nano Silver Fluoride versus Calcium Hydroxide in Indirect Pulp Treatment of Deep Carious Second Primary Molars

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No