Microbiological Evaluation and Clinical 24-month Follow-up of Adhesive Systems on Carious Dentin

NCT05676671 | Completed

• 1 other identifier: 014/2008
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives were to evaluate the antibacterial effect of self-etching adhesives on carious dentin and the clinical results of restorations in a randomized controlled clinical trial. 104 carious deciduous molars (n=92) were randomly allocated to receive one of the self-etching adhesives: Clearfil SE Bond - control (CB - n =53) or Clearfil SE Protect containing MDPB (CP - n=51) after caries removal selective. Clinical, radiographic, photographic and plaster model assessments (n=53 deciduous molars, CB=29, CP=24) of resin restorations were performed at baseline and at 6, 12, and 24 months. Dentin samples (n=51 deciduous teeth; CB=24 and CP=27) were collected immediately after excavation of carious dentin and 3 months later, and cultured for mutans streptococci - (MS), lactobacilli (LB) and total microorganisms (TM). Data were statistically analyzed (p\<0.05).

Conditions

Dental Caries

Keywords

dental caries; primary tooth; dentin-bonding agents; streptococci; randomized controlled trial

Outcome Measures

Primary Outcomes (4)

• Clinical evaluation of restorations using the USPHS criteria

  Each restoration was evaluated for color match, marginal fit, marginal discoloration, anatomical shape, and secondary caries using the USPHS criteria. The Alpha score indicates clinically optimal restoration, the Bravo score is a clinically acceptable situation, except for secondary caries, and the Charlie score indicates clinically unacceptable restorations that must be replaced.

  6 years

• Radiographic evaluation of restorations

  Each restorarion was evaluated by periapical radiographs.

  6 years

• Photographic evaluation of restorations

  Photos of the restorations were taken with a semi-professional digital camera (Sony Cyber-shot DSC-H7, Sony Brasil Ltda, São Paulo, São Paulo), for comparative evaluation of possible clinical changes that occurred during the experimental period. The assessment was performed using parameters similar to those of the clinical direct assessment: color combination, marginal discoloration, anatomical shape, and secondary caries, and excluding marginal integrity.

  6 years

• Evaluation of a plaster model of restorations

  A polyvinyl siloxane impression (Elite HD + Putty Soft, Zhermack, Italy) was taken of each restored tooth and placed on special type IV plaster. The marginal integrity and anatomical structures of the restorations were assessed using the following criteria: 0- Anatomical form and margin with no alteration; 1. Altered anatomical form and with no margin alteration; 2. Anatomical form with no alterations and margin alteration; 3. Altered anatomical form and margin alterations.

  6 years

Study Arms (2)

Self-etching adhesive Clearfil SE Bond

EXPERIMENTAL

Group 1 received treatment with Clearfil SE Bond after selective caries removal

Procedure: Applications of self-etching adhesives and dental restorations

Self-etching adhesiveClearfil SE Protect containing MDPB

EXPERIMENTAL

Group 2 received treatment with Clearfil SE Protect containing MDPB after selective caries removal

Procedure: Applications of self-etching adhesives and dental restorations

Interventions

Applications of self-etching adhesives and dental restorations PROCEDURE

Also known as: Selective caries removal for microbiological evaluation

Self-etching adhesive Clearfil SE Bond; Self-etching adhesiveClearfil SE Protect containing MDPB

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• deciduous molars with one or two surfaces with caries lesions;
• children without systemic problems and who were not using any medication;
• absence of spontaneous pain, edema or fistula, and dental mobility;
• radiographically, caries lesions in the inner half of the dentin thickness, absence of pulp contact with the lesion, absence of internal or external root resorption, and other changes suggestive of degenerative pulp conditions, such as radiolucencies in the furcation or periapical regions or widening of periodontal spaces.

You may not qualify if:

• Caries lesions with involvement of the pulp or periodontal tissues;
• Children with systemic problems.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Cristiane Duque

Araçatuba, São Paulo, 16015050, Brazil

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Cristiane Duque, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 104 carious deciduous molars (n=92) were randomly allocated to receive one of the self-etching adhesives: Clearfil SE Bond - control (CB - n =53) or Clearfil SE Protect containing MDPB (CP - n=51) after caries removal selective

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 9, 2023
• Study Start: February 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: February 1, 2020
• Last Updated: January 9, 2023

Record last verified: 2023-01

Locations

BR (1)