Caries Arresting in Primary Molar Teeth Using SDF VS ART
Primary Purpose
Dental Caries
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
SDF
SDF + ART (SMART technique )
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SDF
SDF + ART ( SMART technique )
Arm Description
Outcomes
Primary Outcome Measures
ECOHIS
Early Childhood Oral Health Impact Scale.
Secondary Outcome Measures
- Clinical effectiveness Caries arrestment/ treatment
International Caries Detection and Assessment System (ICDAS II)
Full Information
NCT ID
NCT05188846
First Posted
December 27, 2021
Last Updated
December 27, 2021
Sponsor
Ola Adel Abdelfadil Ahmed
1. Study Identification
Unique Protocol Identification Number
NCT05188846
Brief Title
Caries Arresting in Primary Molar Teeth Using SDF VS ART
Official Title
Caries Arresting Treatment Using Silver Diamine Fluoride (SDF) Versus SDF Modified Atraumatic Restorative Technique (SMART) for Management of Carious Vital Primary Teeth: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 25, 2022 (Anticipated)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ola Adel Abdelfadil Ahmed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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).
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SDF
Arm Type
Experimental
Arm Title
SDF + ART ( SMART technique )
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
SDF
Intervention Description
1. Group 1: cleaning the occlusal surface to be treated with toothbrush. Decayed tissue from the affected teeth will not be removed for the SDF group.
Clinical procedure for SDF application: it will apply according to the SDF manufacturer Instructions as follows:(1) the surrounding gingival tissues and lips will be protected with petroleum jelly to avoid staining and irritation,(2) the affected tooth will be isolated and keep dry with cotton rolls and saliva ejectors, (3) one drop of SDF (SDI RIVA STAR ), will be placed into a disposable dish, (4) SDF will be applied with a micro-sponge directly to the affected tooth surface(s), (5) allowed to soak in for 2 min, then air-dried. Then will be followed by the Potassium iodide (KI) liquid to decrease discoloration caused by SDF. The KI liquid will be reapplied until no more white perception observed to form.
Intervention Type
Other
Intervention Name(s)
SDF + ART (SMART technique )
Intervention Description
2. Group 2: SDF+ART clinical procedure: (1)cleaning the occlusal surface to be treated with toothbrush.,(2) carious dentin will be removed using a small excavator (Spoon excavator ),(3) the cavity will be cleaned and dried, (4)cavity walls and floor will be conditioned for 10s, then washed and dried, (5) SDF will be applied as mentioned above followed by cavity restoration using resin-reinforced glass ionomer restorative material (SDI RIVA ).
Primary Outcome Measure Information:
Title
ECOHIS
Description
Early Childhood Oral Health Impact Scale.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
- Clinical effectiveness Caries arrestment/ treatment
Description
International Caries Detection and Assessment System (ICDAS II)
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ola Adel, Master
Phone
01012006422
Email
olaadel@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Passant Nagi, PHD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nevine Waly, Professor
Organizational Affiliation
Cairo University
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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Caries Arresting in Primary Molar Teeth Using SDF VS ART
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