Efficacy of Hall Technique in Atypical Lesions on Primary Teeth

Study Overview
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Brief Summary
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Atypical carious cavities could be defined as carious lesions in more than 2 surfaces of the same tooth. Dental practitioners have shown difficulties related to material's maintenance in such type of cavities and therefore, several treatment options have been used. However, most of them have shown a great failure percentage. A randomized clinical trial will be developed with the objective of assessing the Hall technique in comparison with the composite resin incremental technique in 364 primary molars' atypical carious lesions of children between 4 and 9 years old. Initially, two previously calibrated examiners will perform caries diagnosis by means of visual assessment and intraoral examination. Selected teeth will be randomly allocated into two groups. Teeth in the first group will be submitted to prefabricated stainless steel crowns treatment (Hall technique); and the other, to composite resin incremental technique, which will be always placed under rubber dam isolation. Lesions' clinical and radiographic follow-up will be conducted after 6 and 12 months. Treatment's efficacy will be assessed by means of four main outcomes: Longevity, marginal adaptation, possible modification in patients' vertical dimension, and caries lesion progression; Patient-focused criteria (satisfaction, discomfort and quality of life impact); cost-efficacy; and Treatment-related parents', children' and operators' perception. Other variables could be further analysed as secondary outcomes, such as techniques performing time among operators, impact of the socio-economic characteristics on restorations' longevity, and restorations' type impact on the antagonist tooth. Comparisons between groups will be addressed using the Kaplan-Meier survival test as well as Long-Rank test. Cox Regression will be used to enable the assessment of other variables' influence in the results. Significance value of 5% will be adopted for all analysis.

Official Title
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Efficacy of Hall Technique in Atypical Lesions on Primary Teeth: Randomized Clinical Trial

Conditions
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Dental Caries

Intervention / Treatment
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* Other: Dental Restoration with Stainless Crown
* Other: Dental Restoration with Composite Resin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children must have at least one molar with atypical caries lesion (involving more than two surfaces); parents or legal guardians accept and sign the informed consent form. Exclusion Criteria: children with special needs and/or systematic diseases with oral impairment; teeth with spontaneous painful symptoms or necrotized and teeth presenting restorations, sealants, developmental enamel defects, pulp exposure or other signs related to endodontic treatment.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hall Technique<br>single placement of stainless dental crowns on atypical cavities | Other: Dental Restoration with Stainless Crown<br>* Lesions allocated to this group will be treated with stainless dental crowns according to the Hall Technique protocol (Evans & Innes, 2010).<br>|
| Active Comparator: Composite Resin<br>single placement of composite resin on atypical cavities | Other: Dental Restoration with Composite Resin<br>* Surfaces allocated to this group will be treated with composite resin (Z250, 3M ESPE, USA) according to the manufacturer's instructions. Initially, local anesthesia and rubber dam adaptation will be performed. Then, 37% phosphoric acid will be applied on the surface for 15 seconds, followed by spray of water/air for at least 15 seconds. Then, the adhesive system (Single Bond, 3M ESPE, USA) will be applied and light cured according to the manufacturer's instructions. Finally, composite resin (Z250, 3M ESPE, USA) will be applied and light cured according to the manufacturer's instructions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical longevity of restoration | The clinical evaluation will be performed by the non-blinded examiners. The examiner will use the criteria proposed by Innes et al. (2007) for both interventions. | Change from baseline until 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient's vertical dimension | The patient's vertical dimension will be measured with a probe (Williams 14, Hu-Friedy Mfg. Co., United Kingdom) according to the protocol described by van der Zee & van Amerongen (2010). | Baseline, 30 days, 6 and 12 months | 
| Antagonist's level of intrusion | The crown of the antagonist tooth to the treated tooth will be measured with a calliper and a ruler in cervico-occlusal direction (starting on the concave region of the gingival margin up to the center of the occlusal edge), as proposed by Miraglia et al. (2002) and Magalhaes et al. (2011). | Baseline, 6 and 12 months | 
| Treatments' cost-efficacy | The costs of each treatment procedure will be calculated and compared with thresholds values for intervention cost-effectiveness by region, determined by World Health Organization (http://www.who.int/choice/costs/CER_levels/en/). | Through study completion (12 months) | 
| Clinical caries lesion progression | Clinical examination will be performed by a blinded examiner at baseline, 6 months and 12 months after the treatment. These exams will be performed in accordance with Innes et al. (2007). | Baseline, 6 and 12 months | 
| Impact on children's quality of life (4-5 years old) | The oral health related to quality of life will be measured using the validated questionnaire Early Childhood Oral Health Impact Scale (ECOHIS) (Tesch et al., 2008) with 4-5 years old children. It will be applied immediately before the procedure and on 6 months follow-up. | Baseline and 6 months | 
| Impact on children's quality of life (6-9 years old) | The oral health related to quality of life will be measured using the validated questionnaire Child Perceptions Questionnaire (CPQ) with 6-9 years old children (Martins et al., 2009). It will be applied immediately before the procedure and on 6 months follow-up. | Baseline and 6 months | 
| Children's perceptions about the treatment | Children's perceptions about the treatment performed will be evaluated using the validated questionnaire Child's and Parent's Questionnaire About Teeth Appearance (Furtado et al., 2012). This questionnaire will be applied immediately before the procedure and on 6 and 12 months follow-up. | Baseline, 6 and 12 months | 
| Children's satisfaction with the treatment | The patients' satisfaction about the treatment performed will be evaluated using a scale, as performed by Mattos-Silveira et al. (2014). This scale will be applied immediately after the procedure and on 6 months follow-up. | Baseline and 6 months | 
| Children self-reported discomfort | The discomfort of each treatment will be evaluated using the facial scale of Wong-Baker (Wong, Baker, 1998). The patient will be asked to choose the face that is more similar to how she/he felt during the treatment.This answer should be given solely by the child, which means no parental or professional interferences. | Baseline | 
| Marginal adaptation of the stainless steel crowns | This outcome will be evaluated only with the patients randomized to the Hall Technique. The clinician will evaluate the marginal adaptation according to the criteria described by Sharaf & Farsi (2004). | Baseline, 6 and 12 months | 
| Radiographical caries lesion progression | Radiographical examination will be performed by a blinded examiner at baseline, 6 months and 12 months after the treatment. These exams will be performed in accordance with Innes et al. (2007). | Baseline, 6 and 12 months | 
| Biofilm retention of the stainless steel crowns | This outcome will be evaluated only with the patients randomized to the Hall Technique. The clinician will evaluate biofilm retention according to the indice proposed by Silness & Loe (1964), adopted to the primary dentition. | Baseline, 6 and 12 months | 
| Caregivers' perceptions about the treatment | Caregivers' perceptions about the treatment performed will be evaluated using the validated questionnaire Child's and Parent's Questionnaire About Teeth Appearance (Furtado et al., 2012). This questionnaire will be applied immediately before the procedure and on 6 and 12 months follow-up. | Baseline, 6 and 12 months | 
| Clinicians' perceptions about the treatment | Clinicians' perceptions about the treatment performed will be evaluated using the validated questionnaire Child's and Parent's Questionnaire About Teeth Appearance (Furtado et al., 2012). This questionnaire will be applied immediately before the procedure and on 6 and 12 months follow-up. | Baseline, 6 and 12 months | 
| Caregivers' satisfaction with the treatment | The caregivers' satisfaction about the treatment performed will be evaluated using a scale, as performed by Mattos-Silveira et al. (2014). This scale will be applied immediately after the procedure and on 6 months follow-up. | Baseline and 6 months | 
| Clinicians' satisfaction with the treatment | The clinicians' satisfaction about the treatment performed will be evaluated using a scale, as performed by Mattos-Silveira et al. (2014). This scale will be applied immediately after the procedure and on 6 months follow-up. | Baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stainless dental crown, Composite Resin, Primary teeth