NCT02782390

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
364

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 2, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

March 10, 2016

Last Update Submit

May 29, 2022

Conditions

Dental Caries

Keywords

Stainless dental crownComposite ResinPrimary teeth

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • Change in patient's vertical dimension

    Baseline, 30 days, 6 and 12 months

  • Antagonist's level of intrusion

    Baseline, 6 and 12 months

  • Treatments' cost-efficacy

    Through study completion (12 months)

  • Clinical caries lesion progression

    Baseline, 6 and 12 months

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

    Baseline and 6 months

  • +11 more secondary outcomes

Study Arms (2)

Hall Technique

EXPERIMENTAL

single placement of stainless dental crowns on atypical cavities

Other: Dental Restoration with Stainless Crown

Composite Resin

ACTIVE COMPARATOR

single placement of composite resin on atypical cavities

Other: Dental Restoration with Composite Resin

Interventions

Dental Restoration with Stainless CrownOTHER

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

Hall Technique
Dental Restoration with Composite ResinOTHER

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.

Composite Resin

Eligibility Criteria

Age4 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade Sao Leopoldo Mandic

Campinas, São Paulo, 13045-755, Brazil

Location

Related Publications (14)

  • Casagrande L, Dalpian DM, Ardenghi TM, Zanatta FB, Balbinot CE, Garcia-Godoy F, De Araujo FB. Randomized clinical trial of adhesive restorations in primary molars. 18-month results. Am J Dent. 2013 Dec;26(6):351-5.

    PMID: 24640441BACKGROUND

  • Evans D, Innes N. The Hall Technique: A minimal intervention, child centred approach to managing the carious primary molar. A Users Manual. University of Dundee, 3. ed., 2010.

    BACKGROUND

  • Innes NP, Ricketts D, Chong LY, Keightley AJ, Lamont T, Santamaria RM. Preformed crowns for decayed primary molar teeth. Cochrane Database Syst Rev. 2015 Dec 31;2015(12):CD005512. doi: 10.1002/14651858.CD005512.pub3.

    PMID: 26718872BACKGROUND

  • van der Zee V, van Amerongen WE. Short communication: Influence of preformed metal crowns (Hall technique) on the occlusal vertical dimension in the primary dentition. Eur Arch Paediatr Dent. 2010 Oct;11(5):225-7. doi: 10.1007/BF03262751.

    PMID: 20932395BACKGROUND

  • Miraglia SS, Freitas KB, Pinto JHN. Comparative analyze of the mesion-distal (MD) and gengivo-incisal (GI) distances of the upper central incisors with the instrument Trubyte Tooth Indicator. PGRO - Pós-Grad Rev Odontol 5(2):13-17, 2002.

    BACKGROUND

  • Magalhaes JB, Zavanelli AC, Zavanelli RA. Analysis of facial proportion and its relation with dental form, rest and occlusal vertical dimension between institutionalized students. Rev Odontol UNESP 40(5): 215-221, 2011.

    BACKGROUND

  • Tesch FC, Oliveira BH, Leao A. [Semantic equivalence of the Brazilian version of the Early Childhood Oral Health Impact Scale]. Cad Saude Publica. 2008 Aug;24(8):1897-909. doi: 10.1590/s0102-311x2008000800018. Portuguese.

    PMID: 18709230BACKGROUND

  • Martins MT, Ferreira FM, Oliveira AC, Paiva SM, Vale MP, Allison PJ, Pordeus IA. Preliminary validation of the Brazilian version of the Child Perceptions Questionnaire 8-10. Eur J Paediatr Dent. 2009 Sep;10(3):135-40.

    PMID: 19761288BACKGROUND

  • Furtado GE, Sousa ML, Barbosa TS, Wada RS, Martinez-Mier EA, Almeida ME. [Perceptions of dental fluorosis and evaluation of agreement between parents and children: validation of a questionnaire]. Cad Saude Publica. 2012 Aug;28(8):1493-505. doi: 10.1590/s0102-311x2012000800008. Portuguese.

    PMID: 22892969BACKGROUND

  • Mattos-Silveira J, Floriano I, Ferreira FR, Vigano ME, Frizzo MA, Reyes A, Novaes TF, Moriyama CM, Raggio DP, Imparato JC, Mendes FM, Braga MM. New proposal of silver diamine fluoride use in arresting approximal caries: study protocol for a randomized controlled trial. Trials. 2014 Nov 19;15:448. doi: 10.1186/1745-6215-15-448.

    PMID: 25409545BACKGROUND

  • Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.

    PMID: 3344163BACKGROUND

  • Sharaf AA, Farsi NM. A clinical and radiographic evaluation of stainless steel crowns for primary molars. J Dent. 2004 Jan;32(1):27-33. doi: 10.1016/s0300-5712(03)00136-2.

    PMID: 14659715BACKGROUND

  • SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

    PMID: 14158464BACKGROUND

  • Pascareli-Carlos AM, Tedesco TK, Calvo AFB, Floriano I, Gimenez T, Goncalves MDS, Calumby D, Imparato JCP. Survival rate of the Hall technique compared with resin composite restoration in multi-surface cavities in primary teeth: a 1-year randomized clinical trial. J Appl Oral Sci. 2023 Oct 9;31:e20230048. doi: 10.1590/1678-7757-2023-0048. eCollection 2023.

    PMID: 37820181DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

Composite Resins

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Resins, SyntheticPlasticsPolymersMacromolecular SubstancesDental MaterialsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Jose Carlos P Imparato, Professor

    Faculty Sao Leopoldo Mandic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Senior Lecturer

Study Record Dates

First Submitted

March 10, 2016

First Posted

May 25, 2016

Study Start

June 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 1, 2017

Last Updated

June 2, 2022

Record last verified: 2022-05

Locations

BR(1)