ASSESSMENT OF SDF vs. GIC AND HALL TECHNIQUE

NCT05117268 | Unknown DMC

• 1 other identifier: FUI/CTR/2021/7
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Early childhood caries (ECC) ,a global public health problem, highly prevalent and severe with life long implications is entirely preventable. as an alternative to general anesthesia low cost innovative materials such as SDF are promising for low income countries such as Pakistan for reducing the burden of dental caries. SDF may positively transform prevntive and clinical pediatric dental practices and services in Pakistan. FDA approves 38% SDF for arresting caries in vulnerable populations.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• Caries arresting potential of all 3 treatment groups

  At each recall, ICDAS scores were compared to initial values of teeth. Treatment was classified as success when caries on teeth was classified as inactive based on lower ICDAS score compared to initial scores

  6 months

Secondary Outcomes (4)

• Parental aesthetic perception questionnaire.

  24 hours

• Facial Image scale for child anxiety

  24 hours

• Treatment time through digital timer

  24 hours

• Gingival irritation from follow-up interview

  24 hours

Study Arms (3)

Silver Diamine Fluoride

EXPERIMENTAL

In the experimental group, 44 children will be provided with SDF application, after gross debris removal to allow better contact of SDF. The entire dentition will be treated with sodium chloride fluoride varnish to prevent caries.

Procedure: SDF Application for caries arrest

Glass Ionomer Restoration

PLACEBO COMPARATOR

In placebo control group n= 44 participants will be enrolled. High viscosity glass ionomer restoration will be placed after complete caries excavation using high-speed handpiece and air/water coolant. Patient will be dispensed with clear postoperative instructions.

Procedure: Glass ionomer restoration

Hall Technique

ACTIVE COMPARATOR

In active comparator group, n= 44 study participants will be enrolled. Pre-formed metal crowns will be selected according to the tooth size and filled with low viscosity glass ionomer cement and seated using digital/ finger pressure.

Procedure: Hall technique

Interventions

SDF Application for caries arrest PROCEDURE

Intervention will be performed by trained consultants following the recommended protocol for SDF application: (A) Gross debris will be removed from cavity to allow better contact with SDF; (B) Protective coating of petroleum jelly will be applied to surrounding facial skin and lips to prevent chances of temporary tattoo formation; (C) Area to be treated shall be isolated using cotton rolls and saliva ejectors to prevent gingival irritation; (D) Extra caution will be exercised when applying SDF on primary teeth adjacent to permanent teeth to avoid inadvertent black staining; (E) One drop will be used used for the whole appointment. Bent micro-brush is to be used for application time of 1 min is to be used to reduce systemic absorption; (F) Compressed air shall be applied with gentle flow for up to 3 minutes. Entire dentition will be treated with sodium fluoride varnish to prevent caries

Silver Diamine Fluoride

Glass ionomer restoration PROCEDURE

The lesions of control group glass ionomer restoration group will be treated according to following clinical protocol: (A) Isolation of treatment area using cotton rolls and saliva ejectors; (B) Carious lesion excavation using high speed handpiece; (C) High viscosity glass ionomer cement mixed following manufacturer's instructions; (D) Cavity will be slightly overfilled using a flat plastic instrument, the occlusal surface will be protected with Vaseline and gloved finger will be used to apply slight pressure for 30s. Postoperative instructions will be clearly explained to each patient caregiver.

Glass Ionomer Restoration

Hall technique PROCEDURE

In Hall technique, correct size preformed metal crown will be selected and shall be placed without caries excavation. The crown will be filled with glass ionomer cement and seated with finger pressure. Local anesthesia was not used finger pressure was maintained on the crown until the glass ionomer cement was set.

Hall Technique

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients of both genders.
• Age range between 5 to 10 years old.
• Both deciduous maxillary and mandibular untreated teeth.
• Carious teeth categorized as ICDAS code 4, 5 and 6 will be included.
• Active carious lesions on occlusal surface of primary molars

You may not qualify if:

• Permanent dentition will be excluded from this study
• Primary molar showing signs of irreversible pulpitis
• Patients diagnosed with periapical abscess
• Patients allergic to silver
• Medically compromised or patients with childhood impairment and disability.
• Hemophilic patients
• Epileptic patients
• Non-consenting patients for silver staining

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University Islamabad

Islamabad, Federal, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Dr. Beenish Abbas, FCPS

CONTACT

+923067344984; beenishabbas1982@gmail.com

Dr. Amal Farooq, BDS

CONTACT

+923328260373; amalfarooq24@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking strategy is selected because intervention to be performed in all 3 groups is different. Operator cannot be blinded. Consent is necessary for SDF application. For the reasons listed, patient cannot be blinded for the procedure to be done.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A facial image scale shall be shown to participants before treatment and immediately after treatment to determine child anxiety with each treatment where the child will be asked to identify the face that best expressed their feeling at that point of time. Possible adverse events of each treatment shall be recorded by registering any complaint of sensitivity, gingival irritation, tattoo formation, burning, unpleasant taste, silver allergy and nausea. To assess parental aesthetic perception, a questionnaire will be presented that specifically asks if they were annoyed by the appearance of their child, or the child avoided smiling.

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 11, 2021
• Study Start: October 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)