Dental Caries
Conditions
Keywords
Dental Caries, Primary molars, Pediatric Dentistry, Dental treatment outcomes, Hall Technique, Silver Diamine Fluoride, Split-Mouth Design
Brief summary
The goal of this clinical trial is to compare the 18-month clinical success rates of three caries management approaches in primary molars of 60 healthy children aged 4-8 years attending the Department of Pediatric Dentistry at Erciyes University, using a randomized split-mouth design involving 180 treated teeth. The three approaches include the Hall Technique, Silver Diamine Fluoride, and the conventional "drill-and-fill" restorative approach using compomer material. The study will also evaluate pain perception during treatment, child behavior, and treatment acceptability from the perspectives of patients, parents, and dentists. The main questions it aims to answer are: * Do minimally invasive approaches (Hall Technique and Silver Diamine Fluoride) achieve comparable or superior 18-month clinical success rates compared to the conventional drill-and-fill restorative treatment? * Do minimally invasive approaches result in lower pain perception, improved child behavior, and greater treatment acceptability compared to the conventional drill-and-fill approach? Researchers will compare the three treatment approaches applied to different teeth within the same child to see if minimally invasive methods provide similar or improved clinical outcomes and better patient-centered outcomes over 18 months compared to the conventional approach. Participants will: * Contribute three eligible primary molars per child (180 teeth in total). * Have each tooth randomly assigned to one of the three treatment approaches following a split-mouth design. * Receive all three interventions within the same participant, with each treatment applied to a different tooth. * Attend scheduled follow-up visits at 1 month after completion of all interventions, and at 6, 12, and 18 months (final follow-up) for clinical and radiographic evaluation of each treated tooth. * Provide assessments of pain perception and treatment experience, with additional evaluations completed by parents and treating dentists.
Detailed description
This randomized split-mouth clinical trial was designed to evaluate and compare the clinical performance and patient-centered outcomes of three different caries management approaches in primary molars of children. Dental caries remains one of the most prevalent chronic diseases in childhood. Minimally invasive strategies such as the Hall Technique (HT) and Silver Diamine Fluoride (SDF) have gained increasing attention as alternatives to conventional restorative treatment, particularly in young or anxious pediatric patients. However, comparative clinical data evaluating long-term outcomes and patient-centered measures between these approaches and conventional restorative treatment remain limited. A total of 60 healthy children aged 4-8 years requiring restorative treatment for at least three primary molars were included. Using a split-mouth design, each child contributed three eligible primary molars (total: 180 teeth). Within each participant, teeth were randomly allocated to receive one of the following interventions: Hall Technique (placement of a preformed metal crown without caries removal or tooth preparation) Silver Diamine Fluoride application Conventional caries removal followed by restoration using compomer material (drill-and-fill approach) The split-mouth design was selected to minimize inter-individual variability by allowing direct intra-patient comparison of the three treatment modalities. Clinical and radiographic evaluations were performed at 1 month after completion of all interventions and at 6, 12, and 18 months. The primary outcome measure was 18-month clinical success of each treated tooth. Secondary outcomes included pain perception during treatment, child behavior, and treatment acceptability as assessed by patients, parents, and treating dentists. This study aims to provide comparative evidence regarding the effectiveness and acceptability of minimally invasive versus conventional restorative approaches in pediatric dentistry.
Interventions
PROCEDUREHall Technique
Placement of a preformed stainless-steel crown (3M ESPE, USA) cemented with glass ionomer luting cement without tooth preparation, local anesthesia, or caries removal.
Topical application of a two-step protocol using 38% water-based silver diamine fluoride (step 1) followed by potassium iodide (step 2) (Riva Star Aqua, SDI, Australia) on active cavitated caries lesions extending into dentine. Prior to application, unsupported enamel margins are removed to allow plaque access. The procedure is completed with the application of 22,600 ppm fluoride varnish (Duraphat, GABA, Germany). Applications are repeated at 6- and 12-month follow-up visits.
PROCEDURECompomer Restoration
Complete caries removal followed by restoration with compomer material (Dyract, Dentsply, Germany) under local anesthesia as needed.
Sponsors
TC Erciyes University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study uses a randomized split-mouth design in which each participant contributes three eligible primary molars. Within each child, teeth are randomly assigned to receive one of the three interventions (Hall Technique, Silver Diamine Fluoride, or conventional drill-and-fill restoration). Each participant receives all three treatments on different teeth, allowing intra-individual comparison.
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 4 to 8 years. * Systemically healthy children without any medical or syndromic conditions. * Frankl Behavior Rating Scale score of 3 (positive) or 4 (definitely positive). * Presence of at least three unrestored, asymptomatic primary molars with active occluso-proximal dentine caries lesions (ICDAS codes 3, 4, or 5). * Written informed consent obtained from parents or legal guardians, with willingness to attend follow-up visits.
Exclusion criteria
* Refusal to provide informed consent or unwillingness to participate. * Presence of systemic disease or chronic medical conditions requiring special care or antibiotic prophylaxis. * Teeth presenting mobility, symptoms, abscess, or tenderness to percussion. * Radiographic evidence of pulpal pathology. * Non-restorable teeth. * Children with severe lack of cooperation (Frankl score 1 or 2). * Refusal of treatment for aesthetic reasons by the parent or child.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success rate at 18 months | 18 months | Proportion of treated teeth without clinical or radiographic signs of failure, defined as absence of pain, abscess, fistula, pathological mobility, restoration or crown loss, or caries progression requiring further intervention. Outcomes are assessed through clinical and radiographic examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain perception during treatment | Periprocedural (Day 1) | Child-reported pain perception assessed immediately after treatment using the Visual Analogue Scale (VAS) of Faces. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain. Higher scores indicate greater pain intensity. |
| Child behavior during treatment | Periprocedural (Day 1) | Behavioral response assessed during treatment using the Frankl Behavior Rating Scale, a 4-point ordinal scale ranging from 1 (definitely negative) to 4 (definitely positive). Higher scores indicate more cooperative behavior. The treating dentist assigned the score based on observed cooperation during the procedure. |
| Child treatment acceptability | Periprocedural (Day 1) | Child-reported treatment acceptability assessed immediately after treatment using a modified version of the Bell et al. (2010) questionnaire. The instrument consists of five items scored on a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). Higher scores indicate greater treatment acceptability. |
| Parental treatment acceptability | Periprocedural (Day 1) | Parent-reported treatment acceptability assessed immediately after treatment using a five-item questionnaire scored on a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). Higher scores indicate greater treatment acceptability. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORMaria Paula Rueda Manjarres, DDS
Erciyes University, Faculty of Dentistry, Department of Pediatric Dentistry
STUDY_CHAIRHusniye Gumus, DDS, PhD
Erciyes University, Faculty of Dentistry, Department of Pediatric Dentistry
Outcome results
None listed