Efficacy of Hall Technique in Atypical Lesions on Primary Teeth
NCT ID: NCT02782390
Last Updated: 2022-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
364 participants
INTERVENTIONAL
2016-06-30
2017-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hall Technique
single placement of stainless dental crowns on atypical cavities
Dental Restoration with Stainless Crown
Lesions allocated to this group will be treated with stainless dental crowns according to the Hall Technique protocol (Evans \& Innes, 2010).
Composite Resin
single placement of composite resin on atypical cavities
Dental Restoration with Composite Resin
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.
Interventions
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Dental Restoration with Stainless Crown
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
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.
Eligibility Criteria
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Inclusion Criteria
* parents or legal guardians accept and sign the informed consent form.
Exclusion Criteria
* teeth with spontaneous painful symptoms or necrotized and teeth presenting restorations, sealants, developmental enamel defects, pulp exposure or other signs related to endodontic treatment.
4 Years
9 Years
ALL
No
Sponsors
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Faculty Sao Leopoldo Mandic Campinas
OTHER
Responsible Party
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Jose Carlos P Imparato
PhD, Senior Lecturer
Principal Investigators
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Jose Carlos P Imparato, Professor
Role: PRINCIPAL_INVESTIGATOR
Faculty Sao Leopoldo Mandic
Locations
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Faculdade Sao Leopoldo Mandic
Campinas, São Paulo, Brazil
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.
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.
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.
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.
Other Identifiers
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SLM3
Identifier Type: -
Identifier Source: org_study_id
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