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NCT Number: NCT02782390

Efficacy of Hall Technique in Atypical Lesions on Primary Teeth

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:

1. Longevity, marginal adaptation, possible modification in patients' vertical dimension, and caries lesion progression; 2. Patient-focused criteria (satisfaction, discomfort and quality of life impact); 3. cost-efficacy; and 4. 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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculdade Sao Leopoldo Mandic

Campinas, São Paulo, 13045-755, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dental Restoration with Stainless Crown

Other

Lesions allocated to this group will be treated with stainless dental crowns according to the Hall Technique protocol (Evans & Innes, 2010).

Dental Restoration with Composite Resin

Other

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.

Primary outcomes

  1. Clinical longevity of restoration

    Time frame: Change from baseline until 6 and 12 months

    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.

Secondary outcomes

  1. Change in patient's vertical dimension

    Time frame: Baseline, 30 days, 6 and 12 months

    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).

  2. Antagonist's level of intrusion

    Time frame: Baseline, 6 and 12 months

    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).

  3. Treatments' cost-efficacy

    Time frame: Through study completion (12 months)

    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/).

  4. Clinical caries lesion progression

    Time frame: Baseline, 6 and 12 months

    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).

  5. Impact on children's quality of life (4-5 years old)

    Time frame: Baseline and 6 months

    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.

  6. Impact on children's quality of life (6-9 years old)

    Time frame: Baseline and 6 months

    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.

  7. Children's perceptions about the treatment

    Time frame: Baseline, 6 and 12 months

    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.

  8. Children's satisfaction with the treatment

    Time frame: Baseline and 6 months

    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.

  9. Children self-reported discomfort

    Time frame: Baseline

    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.

  10. Marginal adaptation of the stainless steel crowns

    Time frame: Baseline, 6 and 12 months

    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).

  11. Radiographical caries lesion progression

    Time frame: Baseline, 6 and 12 months

    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).

  12. Biofilm retention of the stainless steel crowns

    Time frame: Baseline, 6 and 12 months

    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.

  13. Caregivers' perceptions about the treatment

    Time frame: Baseline, 6 and 12 months

    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.

  14. Clinicians' perceptions about the treatment

    Time frame: Baseline, 6 and 12 months

    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.

  15. Caregivers' satisfaction with the treatment

    Time frame: Baseline and 6 months

    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.

  16. Clinicians' satisfaction with the treatment

    Time frame: Baseline and 6 months

    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.

Sponsors and collaborators

Lead sponsor

Faculty Sao Leopoldo Mandic Campinas

Other

Registry information

Official study title

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

Acronym: SLM2078

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
May 25, 2016
Registry last updated
Jun 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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