Caries Arresting in Primary Molar Teeth Using SDF VS ART

NCT05188846 | Unknown Phase 3

• 1 other identifier: SDF VS ART
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aimed to evaluate the oral health related quality of life ( OHRQoL), during caries management in children with vital carious primary teeth with no signs of irreversible pulpitis using SDF alone or SDF in combination with ART, using Early Childhood Oral Health Impact Scale (ECOHIS).

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• ECOHIS

  Early Childhood Oral Health Impact Scale.

  6 month

Secondary Outcomes (1)

• - Clinical effectiveness Caries arrestment/ treatment

  6 month

Study Arms (2)

SDF

EXPERIMENTAL

Other: SDF

SDF + ART ( SMART technique )

ACTIVE COMPARATOR

Other: SDF + ART (SMART technique )

Interventions

SDF OTHER

1\. Group 1: cleaning the occlusal surface to be treated with toothbrush. Decayed tissue from the affected teeth will not be removed for the SDF group. Clinical procedure for SDF application: it will apply according to the SDF manufacturer Instructions as follows:(1) the surrounding gingival tissues and lips will be protected with petroleum jelly to avoid staining and irritation,(2) the affected tooth will be isolated and keep dry with cotton rolls and saliva ejectors, (3) one drop of SDF (SDI RIVA STAR ), will be placed into a disposable dish, (4) SDF will be applied with a micro-sponge directly to the affected tooth surface(s), (5) allowed to soak in for 2 min, then air-dried. Then will be followed by the Potassium iodide (KI) liquid to decrease discoloration caused by SDF. The KI liquid will be reapplied until no more white perception observed to form.

SDF

SDF + ART (SMART technique ) OTHER

2\. Group 2: SDF+ART clinical procedure: (1)cleaning the occlusal surface to be treated with toothbrush.,(2) carious dentin will be removed using a small excavator (Spoon excavator ),(3) the cavity will be cleaned and dried, (4)cavity walls and floor will be conditioned for 10s, then washed and dried, (5) SDF will be applied as mentioned above followed by cavity restoration using resin-reinforced glass ionomer restorative material (SDI RIVA ).

SDF + ART ( SMART technique )

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Both genders.
• Decayed vital primary molars (asymptomatic teeth with active single-surface lesions, vital pulp no signs of irreversible pulpitis) .

You may not qualify if:

• History of systemic conditions.
• Allergy to silver.
• Oral ulceration.
• Teeth with proximal or multi-surfaces caries, pulp pathology.

Sponsors & Collaborators

• Ola Adel Abdelfadil Ahmed: lead

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Nevine Waly, Professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Ola Adel, Master

CONTACT

01012006422; olaadel@dentistry.cu.edu.eg

Passant Nagi, PHD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: master student

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 12, 2022
• Study Start: January 25, 2022
• Primary Completion: January 1, 2023
• Study Completion: March 1, 2023
• Last Updated: January 12, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share