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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04354636
Other study ID # SMART_ART
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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