Caries Arresting in Primary Molar Teeth Using SDF VS ART

Phase 3

• Conditions: Dental Caries
• Interventions: Other: SDF; Other: SDF + ART (SMART technique )

• Registration Number: NCT05188846
• Lead Sponsor: Ola Adel Abdelfadil Ahmed

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).

Detailed Description

Early childhood caries (ECC) is a type of dental caries in the teeth of infants and children that is represented as one of the most prevalent dental problems in this period, which can lead to pain, infection, interference with eating.

According to the ADA, (ECC) is described as "the presence of one or more decayed ( cavitated or non cavitated lesions), missing (due to caries), or filled tooth surfaces in any primary tooth" in children.

Overall, 50% of children have one or more decayed primary teeth by the end of toddler age, but the importance of these teeth should not be neglected, because, healthy teeth in childhood have an important role in the eruption of healthy permanent teeth, healthy nutrition, and aesthetic appearance.

Conventional treatment methods (drill and fill) involve the use of rotary burs under local anesthesia which develops pain and needs cooperative child and highly trained dental health personnel and consider an invasive technique, on the other hand (ART) is an approach to increase accessibility to restorative treatment, inexpensive and can be employed in regions without electricity and running water. In addition, ART is a minimally invasive treatment that requires no rotary instruments or local anesthesia to remove decayed tissue before sealing the cavity with high viscosity glass ionomer cement (GIC).

(SDF), a low-cost cariostatic agent and a noninvasive method for caries management, treatment with SDF are easy, effective, and well accepted, it is also an alternative to traditional restorative treatment and may influence the reduction of untreated carious lesions in childhood

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-27
• Study First Submitted QC: 2021-12-27
• Last Update Submitted: 2021-12-27
• Study First Posted: 2022-01-12
• Last Update Posted: 2022-01-12
• Study Start: 2022-01-25
• Primary Completion: 2023-01
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age: 4-6 years old age.

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SDF	SDF	-
SDF + ART ( SMART technique )	SDF + ART (SMART technique )	-

Primary Outcome Measures

Name	Time	Method
ECOHIS	6 month	Early Childhood Oral Health Impact Scale.

Secondary Outcome Measures

Name	Time	Method
- Clinical effectiveness Caries arrestment/ treatment	6 month	International Caries Detection and Assessment System (ICDAS II)