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

Dental Caries in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04195022
• Other study ID #: SLM2990II
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: December 2019
• Source: Faculty Sao Leopoldo Mandic Campinas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Faculty Sao Leopoldo Mandic	Campinas	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Faculty Sao Leopoldo Mandic Campinas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival of restoration	To evaluate the survival of restoration by clinical examination with FDI index.	12 months after treatment.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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	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.
Secondary	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.