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Caries Arresting in Primary Molar Teeth Using SDF VS ART

O

Ola Adel Abdelfadil Ahmed

Status and phase

Unknown
Phase 3

Conditions

Dental Caries

Treatments

Other: SDF
Other: SDF + ART (SMART technique )

Study type

Interventional

Funder types

Other

Identifiers

NCT05188846
SDF VS ART

Details and patient eligibility

About

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).

Full 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

Enrollment

50 estimated patients

Sex

All

Ages

4 to 6 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

SDF
Experimental group
Treatment:
Other: SDF
SDF + ART ( SMART technique )
Active Comparator group
Treatment:
Other: SDF + ART (SMART technique )

Trial contacts and locations

0

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Central trial contact

Passant Nagi, PHD; Ola Adel, Master

Data sourced from clinicaltrials.gov

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