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

NCT04005872 | Completed

• 1 other identifier: Cairo U E
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Caries

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Furcation or perapical radiolucency

  12 months

• External or internal root resorption

  12 months

• Widening periodontal membrane space

  12 months

Study Arms (2)

Nano Silver Fluoride

EXPERIMENTAL

2 drops of nano silver fluoride (NSF) applied on the last soft carious layer using micro brush

Drug: Nano Silver Fluoride

Calcium Hydroxide

ACTIVE COMPARATOR

Calcium hydroxide placed on the last soft carious layer approaching the pulp

Drug: Calcium hydroxide

Interventions

Nano Silver Fluoride DRUG

Nano silver fluoride (NSF) is a new material consisting of nano silver particles, chitosan and sodium fluoride. It is a bacteriostatic and bactericidal compound.

Also known as: NSF

Nano Silver Fluoride

Calcium hydroxide DRUG

Calcium hydroxide is a gold standard for indirect pulp capping which induces hard tissue.

Also known as: CaoH

Calcium Hydroxide

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children with known history of allergy to any of the tested materials.
• Children with systemic conditions.
• Parents who refused to participate.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Heba Mohamed Refaat Fouad Genena

Cairo, Egypt

Location

MeSH Terms

Interventions

Calcium Hydroxide

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Model Details: 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

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 2, 2019
• Study Start: October 1, 2019
• Primary Completion: November 5, 2022
• Study Completion: November 30, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)