Clinical trial NCT04354636: Management of Occlusal Caries Using Silver Modified Atraumatic Restorative Treatment Versus Atraumatic Restorative Treatment
Official title: Clinical and Radiographic Evaluation After the Use of Silver Modified Atraumatic Restorative Treatment Versus Atraumatic Restorative Treatment in the Management of Occlusal Caries of Primary Molars in Preschool Children: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Occlusal Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Silver modified atraumatic restorative treatment (intervention) or atraumatic restorative treatment (Control) will be used to manage occlusal caries in preschool children then the molars will be evaluated at the interval of 3,6 and 12 months clinically and 6 and 12 months radiographically

Detailed description: Aim of the study:

To evaluate the clinical and radiographic outcomes after the use of silver modified atraumatic restorative treatment versus atraumatic restorative treatment in the management of occlusal caries in primary molars in preschool children.

PICO:

Population:

Preschool children (4-6 years) with occlusal caries in second primary molars.

Intervention:

Silver modified atraumatic restorative treatment

Comparator/Control:

Atraumatic restorative treatment.

Outcomes:

Pain (provoked or spontaneous) OHRQoL(oral health related to quality of life) Parental esthetic perception Failure of restoration Caries density in radiograph

Time:

3, 6 and 12 months

Study design:

A randomized clinical trial

Eligibility criteria: Inclusion Criteria:

* • Patient and parent cooperation and compliance.

  * Children aged 4 - 6 years
  * Second primary molars with occlusal caries.
  * No clinical signs and symptoms of pulp involvement
  * No radiographic abnormalities

Exclusion Criteria:

* • Uncooperative children or parents

  * Children with systemic diseases
  * Children with previous allergies to any of the used materials

Primary outcomes:
measure: Questioning parent about whether the child have pain between follow up intervals (provoked or spontaneous)
timeFrame: 12 months
Secondary outcomes:
measure: OHRQoL(oral health related to quality of life)
timeFrame: 3 months
measure: Questioning parents about their aesthetic perception
timeFrame: 3 months
measure: ART assessment criteria (Codes 00-90)
timeFrame: 12 months
measure: Caries density in radiograph
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty's pediatric dentiatry clinic
state: Gizq
Study officials:
affiliation: Pediatric Dentistry & Dental Public Health Faculty of Dentistry , Cairo university
name: Sherif B El Tawil, Professor
role: STUDY_DIRECTOR
affiliation: Pediatric Dentistry & Dental Public Health Faculty of Dentistry , Cairo university
name: Dalia M Moheb, Associate professor
role: STUDY_DIRECTOR
References:
citation: Vollu AL, Rodrigues GF, Rougemount Teixeira RV, Cruz LR, Dos Santos Massa G, de Lima Moreira JP, Luiz RR, Barja-Fidalgo F, Fonseca-Goncalves A. Efficacy of 30% silver diamine fluoride compared to atraumatic restorative treatment on dentine caries arrestment in primary molars of preschool children: A 12-months parallel randomized controlled clinical trial. J Dent. 2019 Sep;88:103165. doi: 10.1016/j.jdent.2019.07.003. Epub 2019 Jul 4.
citation: Saber AM, El-Housseiny AA, Alamoudi NM. Atraumatic Restorative Treatment and Interim Therapeutic Restoration: A Review of the Literature. Dent J (Basel). 2019 Mar 7;7(1):28. doi: 10.3390/dj7010028.
citation: Oliveira BH, Rajendra A, Veitz-Keenan A, Niederman R. The Effect of Silver Diamine Fluoride in Preventing Caries in the Primary Dentition: A Systematic Review and Meta-Analysis. Caries Res. 2019;53(1):24-32. doi: 10.1159/000488686. Epub 2018 Jun 6.
citation: van Gemert-Schriks MC, van Amerongen WE, ten Cate JM, Aartman IH. Three-year survival of single- and two-surface ART restorations in a high-caries child population. Clin Oral Investig. 2007 Dec;11(4):337-43. doi: 10.1007/s00784-007-0138-8. Epub 2007 Aug 21.