Management of Occlusal Caries Using Silver Modified Atraumatic Restorative Treatment Versus Atraumatic Restorative Treatment
NCT ID: NCT04354636
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
50 participants
INTERVENTIONAL
2021-09-01
2023-10-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Silver modified atraumatic restorative treatment
Using silver diamine fluoride incorporated with atraumatic restorative treatment
Silver modified atraumatic restorative treatment
Silver diamine fluoride that will be applied during atraumatic restorative treatment
Atraumatic restorative treatment
Using atraumatic restorative treatment without the application of silver diamine fluoride
Atraumatic restorative treatment
Using atraumatic restorative treatment without applying silver diamine fluoride
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Silver modified atraumatic restorative treatment
Silver diamine fluoride that will be applied during atraumatic restorative treatment
Atraumatic restorative treatment
Using atraumatic restorative treatment without applying silver diamine fluoride
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Children aged 4 - 6 years
* Second primary molars with occlusal caries.
* No clinical signs and symptoms of pulp involvement
* No radiographic abnormalities
Exclusion Criteria
* Children with systemic diseases
* Children with previous allergies to any of the used materials
4 Years
6 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mennatallah Sameh Ahmed Farouk Abdelhamid
Principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sherif B El Tawil, Professor
Role: STUDY_DIRECTOR
Pediatric Dentistry & Dental Public Health Faculty of Dentistry , Cairo university
Dalia M Moheb, Associate professor
Role: STUDY_DIRECTOR
Pediatric Dentistry & Dental Public Health Faculty of Dentistry , Cairo university
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty's pediatric dentiatry clinic
Cairo, Gizq, Egypt
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SMART_ART
Identifier Type: -
Identifier Source: org_study_id