ART and Hall Technique for Management of Occlusal-proximal Caries in Primary Molars

Study Overview
=================
Brief Summary
-----------------
The aim of this, two-arm, parallel group, patient-randomised controlled, superiority trial is to evaluate the survival rate of approximal Atraumatic Restorative Treatment (ART) restorations compared to the Hall Technique (HT) placed in a school setting. The investigators will recruit 120 schoolchildren (5-10 years) with at least one occlusal-proximal carious lesion in primary molar. They will be randomized and treated following best-practice protocols to either receive an ART restoration using the high-viscosity glass ionomer cement (EQUIA Forte, capsules, GC Corp.) or a preformed metal crown placed using the HT (3M ESPE) cemented with glass ionomer luting cement (Fuji I Capsules, GC Corp.). Baseline measures and outcome data (at reviews over a three year period) will be assessed through participant report, clinical examination and parent report/ questionnaires.

Detailed Description
-----------------
The selected children will be randomly allocated into 2 groups. The control group will comprise cavities treated by ART, following the protocol proposed by Frencken and Holmgren (1999), while the experimental group will comprise cavities treated by HT, according to the guideline published by Innes and Evans (2011). The allocation of patients in each group will be carried out by a random list generated by a specific computer program. To ensure the allocation concealment, the sequence generated by randomization will be distributed in opaque, sealed envelopes, which will be opened by the operator during the treatment, only after the patient is ready to receive treatment. Operators will be two undergraduate students in dentistry and one experienced specialist in pediatric dentistry that will be trained on how to prepare and fill the cavities according to the original procedures of ART (Frencken and Holmgren, 1999) and also according to HT (Innes and Evans, 2011). The training will include a lecture about the techniques used in this study, as well as a workshop held in the laboratory for students to train handling and application of treatments to be tested. They will also undergo a week of training with patients, to apply the different techniques before starting the study, the latter phase held at the Faculty of Dentistry, University of São Paulo, under the supervision of an experienced dentist in ART and HT. Each child will be allocated for one of the operators with the aid of a random list. All treatments will be performed on the school premises, in field conditions without the use of dental chair or other facilities from a clinical environment.

Official Title
-----------------
ART and Hall Technique for the Management of Occlusal-proximal Caries in Primary Molars: A Randomized Clinical Trial

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Procedure: Atraumatic Restorative Treatment
* Procedure: Hall Technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children aged between 5 and 10 years cooperative behavior presenting good health conditions whose parents or legal guardians accept and sign the consent form with at least one occluso-proximal lesion in primary molar only occlusal-proximal surfaces with caries lesions with dentin involvement cavities accessible to hand instruments used in ART absence of fistula or abscess near the selected tooth absence of pulp exposure in the selected tooth absence of mobility in the selected tooth cavity size in the selected tooth not be bigger than 2.0 mm in the mesial-distal and 2.5 in the occlusal-cervical and bucco-lingual directions. Exclusion Criteria: children younger than 5 years and older than 10 non-cooperative behavior without good health conditions whose parents or legal guardians did not accepted and signed the consent form without any occluso-proximal lesion in primary molar caries in the selected tooth reaching other surfaces (than occlusal-proximal surface) occlusal-proximal surface with caries without dentin involvement cavities not accessible to hand instruments fistula or abscess near the selected tooth pulp exposure in the selected tooth mobility in the selected tooth cavity size bigger than 2.0 mm in the mesial-distal and 2.5 in the occlusal-cervical and - bucco-lingual directions.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atraumatic Restorative Treatment<br>The cavity will be prepared according to the ART (Atraumatic Restorative Treatments) steps and filled with the dental material Glass Ionomer Cement without local anesthesia. | Procedure: Atraumatic Restorative Treatment<br>* No local anaesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with Glass Ionomer Cement (GIC).The cavity will be filled with GIC. After the press-finger technique, the excess of material will be removed.<br>* Other names: Equia Forte;|
| Experimental: Hall Technique<br>The cavity will not receive any preparation. A stainless crown will be placed and cemented with the dental material Glass Ionomer Cement without local anesthesia. | Procedure: Hall Technique<br>* It employs the cementation of preformed metal crowns (PMC) without the need of any prior teeth preparation or caries removal. No local anesthesia is used neither tooth preparation.Different sizes of PMCs will be tested until the smallest size that perfectly fit the tooth is achieved. The PMC will be loaded with the dental material glass ionomer cement (GIC) and placed. Child will asked to bite firmly on it, until it is fitted. The excess of GIC will be removed with hand instruments and dental floss.<br>* Other names: Metal Crowns;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The restoration survival (changes from baseline up to 36 months) | The treatments will be classified success when they present clinical satisfactory aspect, and the failures will be scored as minor failures and major failures (adapted from Innes et al., 2007). The minor failures will be those in which there is a defect in the restoration / crown, but it does not interfere with the tooth health. The major failures will be considered when there signs or symptoms of irreversible pulp damage, such as dental fistula / abscess, tooth fracture or failures that cannot be repaired .The ART-restorations and HT scored as satisfactory will be considered as successful, while those presented minor and major failures will be considered as failure. | The treatments will be evaluated after 1 week up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child self-reported discomfort | For the assessment of discomfort, the Wong-Baker FACES pain rating scale will be used (Wong; Baker, 1988), which is an ordinal six-point scale ranging from 0 to 5. A score of 0 shows a smiling face, indicating no discomfort, whereas a score of 5 shows a crying and sad face, indicating great discomfort. This method was previously validated for the assessment of pain and discomfort in children (Wong; Baker, 1988; Luffy; Grove, 2003; Novaes et al., 2010) | Baseline | 
| Perception and concerns related to tooth appearance. | The Child's and Parent's Questionnaire about Teeth Appearance will be applied as interview to children in the school as well as being filled out by their parents / caregivers at home (Furtado et al., 2012). This instrument has a version for kids and a version for their parents, including questions related to physical, psychological and social order, beyond the perceptions of color change and other aesthetic conditions related to the child´s teeth. | baseline up to 6 months | 
| Acceptance of children in relation to treatments performed. | The questionnaire for the evaluation of acceptance in relation to treatment performed will be applied as interview to children in the school. The questionnaire for the children contains 6 items and employs a 5-point pictorial Likert scale. The response possibilities were: strongly agree, agree, indifferent, disagree and strongly disagree. The questionnaires were based on questionnaires used by Bell et al. (2010) They were rewritten in order to be useful for both the ART and the HT. The questionnaires will be translated from English to Portuguese by a Brazilian dentist who is fluent in both languages. The first and last question for the children was identical to control the reliability of answering. | Immediately after treatment (in the same appointment) | 
| Acceptance of parents in relation to treatments performed. | The questionnaire for the evaluation of acceptance in relation to treatment performed will be filled out by their parents / caregivers at home. The questionnaire for the children contains 6 items and employs a 5-point pictorial Likert scale. The response possibilities were: strongly agree, agree, indifferent, disagree and strongly disagree. The questionnaires were based on questionnaires used by Bell et al. (2010) They were rewritten in order to be useful for both the ART and the HT. The questionnaires will be translated from English to Portuguese by a Brazilian dentist who is fluent in both languages. The first and last question for the children was identical to control the reliability of answering. | Immediately after treatment (in the same appointment) | 
| Occlusal vertical dimension assessment | The distance between the most coronal points of the primary canines at the treatment side will be used as determination of the Occlusal vertical dimension assessment (OVD - van der Zee, van Amerongen, 2011). The most coronal point of the upper canine will be marked on the lower canine when biting in maximal occlusion using a pencil. Subsequently the distance between the marked point and the most coronal point of the lower canine will be measured using a digital calliper (GT-DC-02, Globotronics, Meer, BE). If measuring the OVD score on the treatment side is impossible because of tooth loss, the contralateral side will be used to measure the OVD score. | The measurements will be done before treatment, immediately after treatment (in the same appointment) and at each check-up appointment (1, 2 and 3 weeks and 1, 6, 12, 18, 24, 30 and 36 months) | 
| Cost-effectiveness assessment | The cost of treatments will be calculated then taking into account: Capital cost: Fixed cost of equipment and instruments such as the cost of autoclave, examination kits; Materials cost or cost of expendable supplies such as gloves, masks, articulating paper, restorative material and PMCs; Labor costs will include salaries of personnel such as a dentist and a dental nurse per day using the maximum levels of the Brazilian Public Health Service salary scales for these professionals in the city treatments will be performed and Time taken to do each procedure of restorative treatments using a stopwatch that will be started when the patient has his/her mouth open and the operator is about to start the restorative intervention and will be stopped when the child stands up from the treatment table. | Up 36 months | 
| Oral Health Quality of life (OHRQoL) assessment | The perceptions of parents and children regarding the OHRQoL will be evaluated. For that, the Child Perceptions Questionnaire validated for Brazilian children which takes into account the cognitive abilities and lifestyles in an age ranging from 8 to 10 years (CPQ8-10) will be used (Barbosa et al., 2009). The instrument consists of 14 questions, distributed into four domains (child symptoms, function, psychological, and self-image/social interaction domains) and in a family impact section (oral symptoms, functional limitations, emotional well-being and social well-being). | Before the treatment and during the 6 months recall | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atraumatic Restorative Treatment, Occlusoproximal, Primary Teeth, Glass Ionomer Cements, Hall Technique