Treatment of Initial Caries Lesions on Proximal Surfaces of Primary Molars

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Sao Paulo
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Mariana Minatel Braga, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01477385
First received: November 16, 2011
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

This study aims to evaluate the effectiveness of 30% silver diamine fluoride in the treatment of clinically caries lesions in enamel, with radiographic image restricted to the enamel or the outer third of dentin on the proximal surfaces of primary molars. It also aims to compare it to the resin infiltration and to the control of proximal biofilm through the oral hygiene.


Condition Intervention
Dental Caries
Compliance Behavior
Procedure: caries infiltrant
Procedure: Diammine silver fluoride
Procedure: Dental Flossing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Initial Caries Lesions on Proximal Surfaces of Primary Molars : a Randomized Placebo-controlled Study.

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • progression of initial lesion caries [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • progression of initial lesion caries [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 141
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Resin Infiltration Procedure: caries infiltrant
After cleaning the proximal surface with caries lesion, it will be performed the local infiltration anesthesia and adaptation of the rubber dam. The adjacent tooth will be protected by plastic or metal strip. Hydrochloric acid 15% will be applied on the lesion for 120s, which will be washed and dried. The surface should be dried by applying 95% ethanol and air-way syringe. The resin infiltration (Icon, DMG) will be applied on the lesion for 120s. The resin will be polymerized and applied again for 30s and polymerized. At the end, patients and their caregivers will receive instructions for daily flossing. For children who do not belong to this group will be held only inserting the rubber dam and applied sterile water as a substitute for acid and resin infiltration.
Other Name: Icon
Active Comparator: 30% Silver Diammine Fluoride Procedure: Diammine silver fluoride
It will be cleaned like group I. Soft tissues will be protected with petroleum jelly. The 30% silver diamine fluoride (Cariestop, Biodinamica) will be applied with a disposable microbrush for 3m. Then the surface will be washed for 30s. Children who do not belong to this group will receive sterile water application, as a placebo, using the same technique in Group II.
Other Name: Cariestop
Placebo Comparator: Oral Hygiene Procedure: caries infiltrant
After cleaning the proximal surface with caries lesion, it will be performed the local infiltration anesthesia and adaptation of the rubber dam. The adjacent tooth will be protected by plastic or metal strip. Hydrochloric acid 15% will be applied on the lesion for 120s, which will be washed and dried. The surface should be dried by applying 95% ethanol and air-way syringe. The resin infiltration (Icon, DMG) will be applied on the lesion for 120s. The resin will be polymerized and applied again for 30s and polymerized. At the end, patients and their caregivers will receive instructions for daily flossing. For children who do not belong to this group will be held only inserting the rubber dam and applied sterile water as a substitute for acid and resin infiltration.
Other Name: Icon
Procedure: Diammine silver fluoride
It will be cleaned like group I. Soft tissues will be protected with petroleum jelly. The 30% silver diamine fluoride (Cariestop, Biodinamica) will be applied with a disposable microbrush for 3m. Then the surface will be washed for 30s. Children who do not belong to this group will receive sterile water application, as a placebo, using the same technique in Group II.
Other Name: Cariestop
Procedure: Dental Flossing
In this group, the child will perform only mechanical removal of biofilm to floss daily. After cleaning the proximal surface, it will be held the same relative isolation and the child will receive placebos in the other groups. All groups will receive instructions for the use of dental floss.
Other Name: Oral hygiene
Placebo Comparator: Resin Infiltration Placebo Procedure: Diammine silver fluoride
It will be cleaned like group I. Soft tissues will be protected with petroleum jelly. The 30% silver diamine fluoride (Cariestop, Biodinamica) will be applied with a disposable microbrush for 3m. Then the surface will be washed for 30s. Children who do not belong to this group will receive sterile water application, as a placebo, using the same technique in Group II.
Other Name: Cariestop
Procedure: Dental Flossing
In this group, the child will perform only mechanical removal of biofilm to floss daily. After cleaning the proximal surface, it will be held the same relative isolation and the child will receive placebos in the other groups. All groups will receive instructions for the use of dental floss.
Other Name: Oral hygiene
Placebo Comparator: 30% diamminne silver fluoride placebo Procedure: caries infiltrant
After cleaning the proximal surface with caries lesion, it will be performed the local infiltration anesthesia and adaptation of the rubber dam. The adjacent tooth will be protected by plastic or metal strip. Hydrochloric acid 15% will be applied on the lesion for 120s, which will be washed and dried. The surface should be dried by applying 95% ethanol and air-way syringe. The resin infiltration (Icon, DMG) will be applied on the lesion for 120s. The resin will be polymerized and applied again for 30s and polymerized. At the end, patients and their caregivers will receive instructions for daily flossing. For children who do not belong to this group will be held only inserting the rubber dam and applied sterile water as a substitute for acid and resin infiltration.
Other Name: Icon
Procedure: Dental Flossing
In this group, the child will perform only mechanical removal of biofilm to floss daily. After cleaning the proximal surface, it will be held the same relative isolation and the child will receive placebos in the other groups. All groups will receive instructions for the use of dental floss.
Other Name: Oral hygiene

Detailed Description:

The sample will be comprised of 141 patients between 3 to 10 year-old and 141 patients between 12 and 18 years old, who present at least one proximal surface with initial caries lesion. Patients will be randomly allocated to treatments, according to the technique to be employed: (I) resin infiltration (II) 30% diamine silver fluoride, (III) just daily flossing by the patient. All subjects will receive placebo treatments performed in other groups. The teeth will be evaluated by clinical and radiographic exams at baseline and after 1, 3, 6, 12, 18 and 24 months. In 1, 3 and 18 months will just be evaluated aspects related to the biofilm.

  Eligibility

Ages Eligible for Study:   3 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Distal surface of the first molar, the mesial surface of the second molar and distal surface of the second molar, when the first permanent molar is present. These surfaces with initial caries lesion (ICDAS 1, 2 or 3).

Exclusion Criteria:

  • Mesial surface of the first molar by the smaller contact with the distal surface of the primary canines. It will be also excluded the surfaces that show proximal restorations, sealants, cavities, defects, as well as intact teeth.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01477385

Contacts
Contact: Mariana M Braga, PhD 55 11 30917835 mmbraga@usp.br

Locations
Brazil
Universidade de São Paulo Recruiting
São Paulo, Brazil, 05508-000
Contact: Mariana Braga, PhD    55 11 30917835    mmbraga@usp.br   
Principal Investigator: Fausto Mendes, PhD         
Sub-Investigator: Juliana Silveira, DDS         
Sponsors and Collaborators
University of Sao Paulo
University of Copenhagen
Investigators
Principal Investigator: Mariana M Braga, PhD University of Sao Paulo
  More Information

No publications provided

Responsible Party: Mariana Minatel Braga, Phd, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01477385     History of Changes
Other Study ID Numbers: 002
Study First Received: November 16, 2011
Last Updated: June 2, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
dental caries
primary teeth
permanent teeth
silver diamine fluoride

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014