Comparison of Silver Diamine Fluoride and Sodium Fluoride Varnish to Prevent and Arrest Root Caries in Older Adults

NCT04432415 | Suspended

• 1 other identifier: UNAMexico CIE/0810/03/2017
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Dental caries (coronal and root) is highly prevalent in older adults. It is important to identify and implement the most effective methods that prevent the formation of root caries lesions and inhibit existing lesions at the community level. A clinical trial will be conducted in three groups of adults 60 years old and older, comparing the application of silver diamine fluoride solution and sodium fluoride varnish in dental root surfaces with caries and sound root surfaces. The objectives are to determine over a 30-month period which of the two agents is most effective in reducing the incidence of root caries, and which is most effective in arresting active root caries lesions. Hypothesis: the incidence of root caries will be lower in the group of subjects treated with silver diamine fluoride compared to sodium fluoride varnish. The arrest of active root lesions will be higher when using silver diamine fluoride compared to sodium fluoride varnish. Signed informed consent will be requested from persons 60 years and over, residents of four long-term care centers and attendees of a day care center in four central states of Mexico: Mexico City, Cuernavaca City, Oaxaca City and Toluca City. All facilities are administered by the National System for Integral Family Development (IFD), a public welfare institution that works at the federal and state levels. Three groups will be formed (60 participants in each), two groups will be administered each of the agents, the third group will be the control group. All groups will receive dental health education (oral hygiene, instructions for care and hygiene of removable dental prosthesis, information on prevention of coronal and root caries and periodontal diseases). The preventive agents will be administered according to the manufacturer's instructions. Clinical evaluations will be carried out at baseline 6, 12, 18, 24 and 30 months. The incidence of root caries among the groups will be compared with the percentage of active root lesions that were arrested and that remained inactive. If the greater efficacy of silver diamine fluoride is proven, it can be proposed for use in caries preventive programs for older persons, reducing the risk of tooth loss and improving quality of life. It will also serve as a guide for dental surgeon in-office decision-making regarding the method to use to prevent and limit root caries lesions in older adults at risk.

Conditions

Root Caries

Keywords

root caries; Fluorides; aged; incidence; Mexico; Long-Term Care

Outcome Measures

Primary Outcomes (1)

• Incidence of root caries lesions

  Number of new caries lesions

  30 months

Secondary Outcomes (1)

• Arrested root caries lesions

  30 months

Study Arms (3)

Group Silver Diamine Fluoride

EXPERIMENTAL

Participants receive Annual applications of 38% SDF solution and semestral applications of artificial saliva and a personalized dental health education program.

Device: Silver Diamine Fluoride

Group Sodium Fluoride Varnish

EXPERIMENTAL

Participants receive semestral applications of Sodium Varnish Fluoride and a personalized dental health education program.

Device: Soduim Fluoride Varnish

Placebo

PLACEBO COMPARATOR

Participants receive semestral apllications of artificial saliva and a personalized dental health education program.

Device: Placebo

Interventions

Silver Diamine Fluoride DEVICE

Annual application od Silver Diamine Fluoride

Group Silver Diamine Fluoride

Soduim Fluoride Varnish DEVICE

biannual apllication of Sodium Fluoride Varnish

Group Sodium Fluoride Varnish

Placebo DEVICE

biannual application of artificial saliva

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 60 years of age and older
• At least 5 teeth with gingival recession and exposed root surfaces not indicated for extraction
• No problems performing activities of daily living
• Agree to participate and sign the informed consent.

You may not qualify if:

• Health problems that prevent oral hygiene
• Cognitive problems that prevent understanding oral hygiene instructions
• Salivary gland diseases (hyposalivation)
• Having received radiation therapy to the head and neck
• Deafness
• Active infections of the oral mucosa
• Allergy to silver
• Stomatitis
• Allergy to colophony (component of varnishes)
• Elimination criteria:
• Adults who do not return to subsequent applications of silver diamine fluoride, sodium fluoride varnish, or artificial saliva.

Sponsors & Collaborators

• Universidad Nacional Autonoma de Mexico: lead
• Sistema para el Desarrollo Integral de la Familia: collaborator

Study Sites (1)

Centro Gerontológico Arturo Mundet

Mexico City, 01040, Mexico

Location

Related Publications (6)

• Deutsch A. An alternate technique of care using silver fluoride followed by stannous fluoride in the management of root caries in aged care. Spec Care Dentist. 2016 Mar-Apr;36(2):85-92. doi: 10.1111/scd.12153. Epub 2015 Dec 21.

  PMID: 26687774 BACKGROUND

• Tan HP, Lo EC, Dyson JE, Luo Y, Corbet EF. A randomized trial on root caries prevention in elders. J Dent Res. 2010 Oct;89(10):1086-90. doi: 10.1177/0022034510375825. Epub 2010 Jul 29.

  PMID: 20671206 BACKGROUND

• Zhang W, McGrath C, Lo EC, Li JY. Silver diamine fluoride and education to prevent and arrest root caries among community-dwelling elders. Caries Res. 2013;47(4):284-90. doi: 10.1159/000346620. Epub 2013 Feb 5.

  PMID: 23392087 BACKGROUND

• Sequeira-Byron P, Lussi A. Prevention of root caries. Evid Based Dent. 2011;12(3):70-1. doi: 10.1038/sj.ebd.6400805.

  PMID: 21979764 BACKGROUND

• Richards D. Fluoride has a beneficial effect on root caries. Evid Based Dent. 2009;10(1):12. doi: 10.1038/sj.ebd.6400627.

  PMID: 19322220 BACKGROUND

• Twetman S, Keller MK. Fluoride Rinses, Gels and Foams: An Update of Controlled Clinical Trials. Caries Res. 2016;50 Suppl 1:38-44. doi: 10.1159/000439180. Epub 2016 Apr 22.

  PMID: 27101002 BACKGROUND

MeSH Terms

Conditions

Root Caries

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Aida Borges-Yañez, PhD

  Universidad Nacional Autonoma de Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not know which type of fluoride they are getting. Outcome assesor will not know the type of fluoride or placebo assigned to each group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Participants will be assigned randomly into treatment and control group using a randomization protocol.

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 16, 2020
• Study Start: September 1, 2017
• Primary Completion: July 31, 2019
• Study Completion: December 1, 2021
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)