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

Dental Caries in Children Clinical Trial

Official title:

Efficacy of a Chemically Activated Composite Resin Alkasite in Atypical Caries Lesions of Deciduous Teeth - Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04195386
• Other study ID #: SLM2990
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: January 30, 2021

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 being one of them vestibular or lingual/palatine, are a challenge for restorative dentistry, since the risk of failure of the restorations are related to the number of surfaces involved. Thus, the objective of this project is to conduct a randomized clinical trial in order to evaluate the efficacy and patient-centered outcomes of a chemically-activated alkasite composite resin in atypical lesions of deciduous molars. Deciduous molars of children between 4 and 7 years of age with at least one atypical cavity lesion in deciduous molars will be selected for the ECR. The selected teeth will be randomly divided into two groups: Chemically activated composite resin Alkasite and resin-Modified glass ionomer cement. Clinical and radiographic follow-up of the lesions will be performed for 6 and 12 months. The efficacy of the treatments will be evaluated by the longevity of the restoring procedures and the arrestment of the caries lesions. Patient-centered outcomes will also be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: January 30, 2021
• 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

• Patients general health conditions that may affect the oral cavity

• Patients non-cooperating in relation to the examination

• Patients with orthodontic apparatus

• The parents/guardians or children not to consent to their participation in the study.

• Teeth with pulp exposure

• Teeth with spontaneous pain

• Teeth with mobility

• Teeth with presence of swelling or fistula close to the tooth

• Teeth with 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 Resin-Modified Glass ionomer Cement
Selective removal of dental caries with manual instruments, under relative isolation, application of polyacrylic acid and restoration with resin-modified glass ionomer cement.

Locations

Country	Name	City	State
Brazil	Faculdade Sao Leopoldo Mandic	Campinas	SP

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 visualClinical 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 the restoration.
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 restoration.
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 ° day after the restorative procedure.
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 month of restorative treatment.