Comparison of a Chemically Activated Composite Resin Alkasite With Resin Composite in Atypical Caries Lesions of Deciduous Teeth

Comparison of a Chemically Activated Composite Resin Alkasite With Resin Composite in Atypical Caries Lesions of Deciduous Teeth - A Non-inferiority Randomized Clinical Trial

Atypical cavities, which involve more than two surfaces, one being buccal or lingual/palatal, are a challenge for restorative dentistry, since the risk of restorative failure is related to the number of surfaces involved. Thus, the purpose of this umbrella project is to conduct a randomized controlled trial (RCT) to evaluate the efficacy and patient-centered outcomes of a chemically activated composite alkasite resin in atypical deciduous molar lesions. Primary molars of children aged 4 to 7 years with at least one atypical cavitary lesion in primary molars will be selected for the RCT. The selected teeth will be randomly divided into: Alkasite chemically activated composite resin and Bulk fill composite resin. Clinical and radiographic follow-up of the lesions will be performed for 6 and 12 months. The effectiveness of the treatments will be evaluated by the longevity of the restorative procedures and paralysis of the lesions. Patient-centered outcomes will also be evaluated.

Study Overview

• Status: Unknown
• Conditions: Dental Caries in Children
• Intervention / Treatment: Procedure: Dental Restoration with Chemically activated Composite resin Alkasite; Procedure: Dental Restoration with Bulk fill resin composite

• Study Type: Interventional
• Enrollment (Anticipated): 162
• Phase: Not Applicable

Contacts and Locations

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
      • Sub-Investigator: Ana Paula M de Araújo
      • Sub-Investigator: Bruno P de Posses
      • Sub-Investigator: Débora S Dionísio
      • Sub-Investigator: Jaqueline M Salviogni
      • Sub-Investigator: Lis T Meneghel
      • Sub-Investigator: Malvina S Pereira
      • Sub-Investigator: Mayra de Jesus
      • Sub-Investigator: Naiara S de Almeida
      • Sub-Investigator: Patrícia S Marzarotto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 7 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children will be included who have at least one posterior tooth with atypical caries lesion.

Exclusion Criteria:

• Patients with special needs will be excluded, with general health conditions that may affect the oral cavity, non-cooperating in relation to the examination, which use orthodontic apparatus and the parents/guardians or children not to consent to their participation in the study. In addition, teeth with pulp exposure, spontaneous pain, mobility, presence of swelling or fistula close to the tooth, furcation or cervical injury, teeth with restorations, sealants or enamel formation defects will be excluded.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chemically activated Composite resin Alkasite; Single placement of composite resin on atypical cavities.	Procedure: Dental Restoration with Chemically activated Composite resin Alkasite; Selective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with chemically activated composite resin Alkasite.
Active Comparator: Bulk fill resin composite; Single placement of Bulk fill resin composite on atypical cavities.	Procedure: Dental Restoration with Bulk fill resin composite; Selective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with bulk fill resin composite.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival of restoration	To evaluate the survival of restoration by clinical examination with FDI index.	12 months after treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caries lesion progression	For the evaluation of caries progression, the interproximal radiographic examination will be used to verify an increase of radiolucent image under restoration.	12 months after treatment.
Child discomfort	The child will also be questioned as to the discomfort in relation to the treatment performed. For this will be used the scale of faces of Wong-Baker.	Immediately after the treatment.
Secondary caries lesion or on the surface adjacent to the restored tooth	Presence of caries lesion on the surface adjacent to the restored tooth or on the margins of the restoration by means of visual Clinical Examination.	12 months after treatment.
Perception of children and parents/guardians	To evaluate the satisfaction of the children in relation to the treatment performed. The questionnaire will be used "Child's and parent's questionnaire about teeth appearance".	6 months after treatment.
Operator perception	It will be employed a questionnaire after the completion of the treatment performed. It will also be added a question about the behavior of children during the procedure, which will be categorized as - great behavior, regular or bad.	6 months after treatment.
Parents/Guardians Satisfaction	The parents/guardians will be questioned about the satisfaction regarding the treatment performed in the child. The answer will be scored by a likert scale.	6 months after treatment.
Post Operative sensitivity of the child	The child will also be questioned about the sensitivity of the restorative procedure. For this, the Wong-Baker face scale will be used.	7 days after treatment.
Oral health-related quality of life	The validated Brazilian version of Early Childhood Oral Health Impact Scale (ECOHIS) will be applied to children and should be answered by their parents.	6 months after treatment.

Collaborators and Investigators

• Sponsor: Faculty Sao Leopoldo Mandic Campinas

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): January 30, 2020
• Study Completion (Anticipated): January 30, 2020

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): December 11, 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; Deciduous teeth; Permanent dental restoration
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: SLM2990II

Drug and device information, study documents

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