Dental Caries in Primary Molars
Conditions
Keywords
Chemomechanical caries removal, Rotary method, Sodium hypochlorite gel, caries removal
Brief summary
This randomized clinical trial aims to compare two different methods of caries removal in primary molars: the chemomechanical technique using Cariclast gel and the conventional rotary drilling method. The study will evaluate and compare the pain perception, patient acceptance, and operative time associated with both techniques in children aged 5-7years.
Detailed description
Dental caries is one of the most common chronic diseases in children, and the management of carious lesions in primary teeth should be both effective and minimally invasive. Traditional caries removal using rotary instruments is associated with discomfort and anxiety among pediatric patients. Chemomechanical caries removal (CMCR) agents such as Cariclast have been developed as a more conservative and less traumatic alternative. Cariclast works by softening the infected dentin chemically, allowing its gentle removal without pain or vibration. This randomized controlled clinical trial will compare Cariclast with the conventional rotary drilling method regarding: Pain perception assessed using the FLACC scale. Patient acceptance evaluated using the Visual Analog Scale (VAS). Operative time required to complete the caries removal procedure. All procedures will be performed on cooperative children with occlusal caries in primary molars, without pulpal involvement, attending the Pediatric Dentistry Department, Faculty of Dentistry, Cairo University.
Interventions
PROCEDUREcares removal using cariclast gel
Chemomechanical caries removal using Cariclast gel applied to soften infected dentin, followed by gentle excavation with hand instruments.
PROCEDUREConventional Mechanical Caries Removal
Conventional mechanical caries removal performed using a high-speed rotary handpiece under adequate water cooling, following standard clinical principles for primary molars.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
Yes
Inclusion criteria
* Children: 1. children aged 4-7 years 2. in good general health, and medically free according to parent history. 3. Cooperative patients 4. Children whom their parents will comply with follow-ups. 5. Children whom their parents who accept to sign informed consent Tooth: 1. Broad cavitated occlusal lesion with dentinal involvement 2. (Black's Class I cavity) and occlusal access. 3. Radiograph showing dentinal caries up to two-thirds of the dentinal thickness. 4. The consistency of carious lesions ranges from soft to medium hard. 5. Color of carious lesion ranges from light yellow to brown
Exclusion criteria
* Children: 1. Medically or developmentally compromising conditions 2. Children who will be unable to attend follow-up visits. 3. Children whom their parents refuse to give written formed consent. Teeth: 1. Cases requiring restorative treatment that is not of the Class I variety. 2. Extensively damaged teeth. 3. Radiograph showing dentinal caries of more than two thirds of the dentinal thickness. 4. Caries involving pulp or extending below the gingiva.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Perception During Caries Removal | During the caries removal procedure (immediate intraoperative assessment) | Pain perception will be evaluated using the Wong-Baker FACES Pain Rating Scale. Before starting caries removal, the child will be briefly shown the six facial expressions and given age-appropriate instructions to ensure proper understanding of how to express discomfort. During the procedure, immediately at the moment of peak stimulation, the child will be asked to point to the face that best reflects their pain experience. The selected score (ranging from 0 to 10) will be recorded as an objective standardized measure of procedural pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child Acceptance of the Caries Removal Technique | Immediately after the procedure | Patient acceptance will be measured immediately after completion of the caries removal procedure using a Visual Analog Scale (VAS). The scale consists of a 100-mm horizontal line with descriptors at each end indicating the extremes of comfort, ranging from "no discomfort" to "worst possible discomfort." Each child will be asked to mark a point on the line that best represents their overall comfort during the procedure. The distance in millimeters from the "no discomfort" anchor to the child's mark will be measured to quantify the level of acceptance. Higher scores indicate lower acceptance of the technique. |
Contacts
CONTACTnoran mohamed kamel, bechelor
STUDY_DIRECTORranda youssef abdelgawad, professor
Cairo University
STUDY_DIRECTORrana sobhy saeed
Cairo University
Outcome results
None listed