Treatment of Initial Caries Lesions on Proximal Surfaces of Primary Molars - Full Text View

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:

MedlinePlus related topics: Dental Health Tooth Decay

Drug Information available for: Fluorine Fluoride

U.S. FDA Resources

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 by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mattos-Silveira J, Floriano I, Ferreira FR, Viganó ME, Frizzo MA, Reyes A, Novaes TF, Moriyama CM, Raggio DP, Imparato JC, Mendes FM, Braga MM. New proposal of silver diamine fluoride use in arresting approximal caries: study protocol for a randomized controlled trial. Trials. 2014 Nov 19;15:448. doi: 10.1186/1745-6215-15-448.


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 Stomatognathic Diseases Tooth Demineralization Tooth Diseases Fluorides	Cariostatic Agents Pharmacologic Actions Physiological Effects of Drugs Protective Agents

ClinicalTrials.gov processed this record on March 02, 2015