Management of Occlusal Caries Using Silver Modified Atraumatic Restorative Treatment Versus Atraumatic Restorative Treatment

Occlusal Caries Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04354636
• Other study ID #: SMART_ART
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: November 1, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: April 2020
• Source: Cairo University
• Contact: Mennatallah S Abdelhamid, Master's degree
• Phone: 00201148787211
• Email: mennatallah89[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Occlusal Caries

Intervention

Drug:
• Silver modified atraumatic restorative treatment
Silver diamine fluoride that will be applied during atraumatic restorative treatment

Other:
• Atraumatic restorative treatment
Using atraumatic restorative treatment without applying silver diamine fluoride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (4)

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. — View 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). pii: E28. doi: 10.3390/dj7010028. Review. — View 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. Epub 2007 Aug 21. — View Citation

Vollú AL, Rodrigues GF, Rougemount Teixeira RV, Cruz LR, Dos Santos Massa G, de Lima Moreira JP, Luiz RR, Barja-Fidalgo F, Fonseca-Gonçalves 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questioning parent about whether the child have pain between follow up intervals (provoked or spontaneous)	Pain reported-Pain history that occurs after treatment at any point (will be recorded at the follow up intervals) Outcome will be binary (yes/no)	12 months
Secondary	OHRQoL(oral health related to quality of life)	The Early Childhood Oral Health Impact Scale (A-ECOHIS) Score 0-52. There will be 13 questions each question with a score 0-5 where 0 = excellent, 1=very good, 2=good, 3=fair , 4=poor and 5= unknown so the less the score the better is the oral health related to quality of life.	3 months
Secondary	Questioning parents about their aesthetic perception	Parent reported (parent is asked whether he/she is accepting the tooth appearance or not) Outcome will be binary (yes/no)	3 months
Secondary	ART assessment criteria (Codes 00-90)	Failure of restoration according to the code in the ART assessment criteria (Codes 00-90).; Code 00 or 10 are considered successful, codes 11-40 are classified as failures, and codes 50-90 are assigned in case the tooth was unavailable for evaluation	12 months
Secondary	Caries density in radiograph	Pixel grey value	12 months