Effectiveness Silver Diamine Fluoride Versus Sodium Fluoride in Arresting Caries Around Crown Margins in Older Adults

NCT04255251 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: Universityof New Engalnd
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Dental caries is a multifactorial, progressive disease which is the major causes of dental pain, infection and tooth loss. Dental caries can substantially compromise the quality of life in older adults 1 2. As the number of older adults in the US increases, the dental professionals have become increasingly concerned with the dental need of elderly and preventive regimes to reduce the incidence of caries3 . Prevention becomes an area of paramount importance. Many studies have advocated nonsurgical intervention for shallow dentin caries lesion.The most effective method for prevention to date is considered to be fluoride. In the United states fluoride has been incorporated in many ways like water fluoridation, fluoride mouth wash, dentifrices and professionally applied fluoride varnishes . The American Dental Association (ADA) recommended the use of fluoride for patients of all ages who are at risk of developing dental caries7 . With the high success of fluoride, another treatment method using Silver Diamine Fluoride (SDF) is gaining popularity in the United States. SDF has been used in many countries like Japan, Australia, China, and Cuba for treatment of caries . Successful treatment data from other countries is promising, and promoting the use of SDF in the United States. SDF is available in the United States as 38% aqueous solution and approved as a desensitizing agent. American Dental Association published an evidence-based clinical practice guideline on nonrestorative treatments for caries teeth and recommended use of SDF on a carious cavitated lesion on permanent teeth9 . Clinical studies have shown the effectiveness of SDF in arresting root caries in older adults.

Conditions

Caries Roots; Flouride Varnish; Caries; Dentin; Caries Arrested

Outcome Measures

Primary Outcomes (1)

• Tactile exam to evaluate extend of caries around tooth margin

  WHO ball end probe will be used to detect cavities around the restoration margins. Code 0: Sound tooth surface with restoration Code 1: First visual change in enamel Code 2: Distinct visual change in enamel/ dentin adjacent to restoration Code 3: Carious defect of more than 0.5 mm Code 4: Marginal caries in enamel/dentin/cementum adjacent to restoration with dark shadow Code 5: Distinct cavity adjacent to restoration Code 6: Extensive distinct cavity with visible dentine

  Every 6 month for next 3 years

Secondary Outcomes (1)

• DIAGOdent: laser fluorescence to aid in the detection of caries

  Every 6 month for next 3 years

Study Arms (2)

Intervention group

EXPERIMENTAL

Subjects in this group will receive Silver Diamine Fluoride around their crown margins every six month for the next 3 years.

Drug: Silver Diammine Fluoride

Fluoride varnish group

ACTIVE COMPARATOR

Subjects in this group will receive fluoride varnish around their crown margins every six month for the next 3 years.

Drug: Fluoride Varnishes

Interventions

Silver Diammine Fluoride DRUG

Subjects will receive SDF around their crown margins every 6 months for next 3 years.

Intervention group

Fluoride Varnishes DRUG

Subjects will receive SDF around their crown margins every 6 months for next 3 years.

Fluoride varnish group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• years old with crown/bridges
• Open crown margins
• Decay present around crown margins
• Pt is not intention to go with the conventiontial restorative treatment to replace the crown for any reason
• Subjects who can do the follow up for at least one year

You may not qualify if:

• Teeth with periapical lesion
• Teeth which have pain to percussion
• Subjects who have silver or fluoride allergy
• Subjects who have gingivitis
• Subjects who have stomatitis
• Subjects who have tooth mobility
• Subjects who have furcation involvement

Sponsors & Collaborators

• University of New England: lead

Study Sites (1)

University of New England

Portland, Maine, 04101, United States

RECRUITING

Related Publications (2)

• Giusti L, Steinborn C, Steinborn M. Use of silver diamine fluoride for the maintenance of dental prostheses in a high caries-risk patient: A medical management approach. J Prosthet Dent. 2018 May;119(5):713-716. doi: 10.1016/j.prosdent.2017.06.007. Epub 2017 Sep 6.

  PMID: 28888414 BACKGROUND

• Seifo N, Cassie H, Radford JR, Innes NPT. Silver diamine fluoride for managing carious lesions: an umbrella review. BMC Oral Health. 2019 Jul 12;19(1):145. doi: 10.1186/s12903-019-0830-5.

  PMID: 31299955 RESULT

MeSH Terms

Conditions

Root Caries

Interventions

silver diamine fluoride; Fluorides, Topical

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Shaista Rashid, B.D.S, M.S.

CONTACT

2072214861; srashid2@une.edu

Mohamed ElSalhy, MPH, PHD

CONTACT

2072214862; melsalhy@une.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will not know which type of fluoride they are getting around their crow margins. Principal investigator will measuring the extend of the decay does not know about the type of fluoride treatment patient got.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

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

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: February 5, 2020
• Study Start: June 26, 2021
• Primary Completion: January 3, 2023
• Study Completion: January 3, 2024
• Last Updated: October 5, 2021

Record last verified: 2021-10

Locations

US (1)