Efficacy of Sealing Molars: Split-mouth Randomized Clinical Trial

Efficacy of Resin Sealing in Deciduous and Permanent Molars: Split-mouth Randomized Clinical Trial

The sealing of fossae and fissures is an effective procedure in preventing occlusal caries lesions. However, there are gaps regarding its efficacy in the treatment of initial enamel lesions. In addition, there are no studies in the literature that have compared the longevity of sealings performed with the different sealants available in the market. Thus, the objective of this study is to evaluate the efficacy of fossae and fissures sealings performed with a low-cost resinous sealant in occlusal lesions in enamel in permanent and deciduous molars. This is a multicenter clinical study of non-inferiority, randomized, controlled, double blind (patient and operator) with 60 deciduous molars and 340 permanent molars of children 4 and 9 years of age. The sample unit will be the tooth, which will be randomized into two groups using a distributed randomization list in mixed envelopes that will be open only at the time of the procedure. The teeth allocated in the test group will be treated with the sealant preventâ; Those allocated in the control group will employ the Fluroshieldâ sealant. In both groups the procedure will follow the manufacturer's standards. The efficacy of the sealant will be evaluated by means of clinical and radiographic control at 6, 12 and 18 months after the procedure. Secondary outcomes, such as retention, cost, acceptability and quality of life, will also be evaluated.

Study Overview

• Status: Unknown
• Conditions: Dental Caries
• Intervention / Treatment: Procedure: High cost; Procedure: Low Cost

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jose Carlos P Imparato, PhD; Phone Number: +5511998686008; Email: jimparato@usp.br

Study Locations

• Brazil
  • Sao Paulo
    • Campinas, Sao Paulo, Brazil, 13045755
      • Recruiting
      • Faculty Sao Leopoldo Mandic
      • Contact: Jose Carlos P Imparato, PhD; Phone Number: +551935183601; Email: jimparato@usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children with at least two deciduous and/or permanent molars with occlusal caries lesions scores 1, 2 or 3 of the Icdas (Ismail et al., 2007) will be included, one on each side, preferably from the same arch.

Exclusion Criteria:

• Patients with special needs;
• using orthodontic appliances;
• with systemic diseases;
• Teeth that present restorations, sealants, formation defects, deep caries lesions that may lead to pulp impairment;
• teeth with fistula and/or abscess;
• teeth with spontaneous painful symptomatology.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High Cost; Restoration using a high-cost sealant	Procedure: High cost; Surfaces allocated to this group will be treated with a high-cost sealant (Fluroshield®, Dentsply, São Paulo, Brazil), according to the manufacturer's instructions.
Experimental: Low Cost; Restoration using a low-cost sealant	Procedure: Low Cost; Surfaces allocated to this group will be treated with a low-cost sealant (Prevent®, FGM Produtos Odontológicos, Santa Catarina, Brazil), according to the manufacturer's instructions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental caries progression	Caries progression will be evaluated radiographically by three previously trained evaluators (through theoretical classes and evaluation of 13 clinical photographs) and calibrated. These examiners will not know the chronological order and compare the images two to two first by two evaluators and when there is disagreement between the two, the third examiner shall be called for tie-breaker. The possible progression of the treated caries lesion will be codified as: Present progression: Increased radiolucidity area of the Lesion; Absent progression: No increase in the area of radiolucidity of the lesion.	Every 6 months up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness	The costs of each treatment procedure will be calculated and compared with thresholds values for intervention costeffectiveness by region, determined by World Health Organization (http://www.who.int/choice/costs/CER_levels/en/).	18 months
Impact on children's quality of life	The oral health related quality of life will be measured using a validated questionnaire according to the children's age. The "Early Childhood Oral Health Impact Scale" (ECOHIS) (Tesch et al., 2008) will be applied with 4-5 years old children. The "Child Perceptions Questionnaire" (CPQ) will be used for 6-9 years old children (Martins et al., 2009). They will be applied immediately before the procedure and on 18 months follow-up and we will measure the difference between answers at baseline and the end of treatment (18months)	Baseline and 18 months
Children self-reported discomfort	The discomfort of each treatment will be evaluated using the facial scale of Wong-Baker (Wong, Baker, 1988). The patient will be asked to choose the face that is more similar to how he/she felt during the treatment. The answer should be given solely by the child, which means no parental or professional interferences. Each face corresponds to a number, within a numeric scale from 0 to 5, with 0 no discomfort and 5 the greatest discomfort. At the end, the averages of each score will be compared between the experimental groups.	Baseline
Sealant retention	The elements submitted to the treatment will be codified in accordance with Hesse et al. (2012): Full retention: When the restorer material was Intact when subjected to clinical examination;; Partial loss: When there was a loss of a part of the restorer material previously applied;; Total Loss: When the restorer material has been lost in its entirety.	Every 6 months up to 18 months

Collaborators and Investigators

• Sponsor: Faculty Sao Leopoldo Mandic Campinas

Publications and helpful links

General Publications

• Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.
• Hesse D, Bonifacio CC, Mendes FM, Braga MM, Imparato JC, Raggio DP. Sealing versus partial caries removal in primary molars: a randomized clinical trial. BMC Oral Health. 2014 May 28;14:58. doi: 10.1186/1472-6831-14-58.
• 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.
• 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.
• Pitts N, Melo P, Martignon S, Ekstrand K, Ismail A. Caries risk assessment, diagnosis and synthesis in the context of a European Core Curriculum in Cariology. Eur J Dent Educ. 2011 Nov;15 Suppl 1:23-31. doi: 10.1111/j.1600-0579.2011.00711.x.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Actual): February 15, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): December 10, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: dental caries; molars; Pit and Fissure Sealants
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: SLM 5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No