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

Caries; Dentin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04255251
• Other study ID #: Universityof New Engalnd
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 26, 2021
• Est. completion date: January 3, 2024

Study information

• Verified date: October 2021
• Source: University of New England
• Contact: Shaista Rashid, B.D.S, M.S.
• Phone: 2072214861
• Email: srashid2[@]une.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Potential subjects will be identified through regular appointments. Screening will be performed on subjects to determine their eligibility based on inclusion and exclusion criteria. Subjects will sign an informed consent before enrollment in the study. Patient will be receiving one of the two fluoride treatments, Silver Diamine Fluoride or Sodium fluoride, to arrest caries around crown margins. Clinical and radiographic exam will be performed on all the participants.

Clinical exam will include the following

1. DIAGOdent:

2. Tectile exam:

The procedures of every clinical appointments will be as following:

First appointment:

Visit will include

• Health history

• Caries risk assessment

• Clinical exam (DIAGNOdent, tactile) (described above)

• Radiograph (described above)

• Subject will sigh consent form

• Treatment group will receive SDF

• Control group will receive Fluoride varnish

Second visit (6 month from the first appointment ):

Visit will include

• Health history retake

• Caries risk assessment retake

• New Clinical exam (DIAGNOdent, tactile)

• New Radiograph

• Subject will receive his or her treatment according to their allocation

Third visit (12 month from the first appointment ):

Visit will include

• Health history retake

• Caries risk assessment retake

• New Clinical exam (DIAGNOdent, tactile)

• New Radiograph

• Subject will receive his or her treatment according to their allocation

Third visit (12 month from the first appointment ):

Visit will include

• Health history retake

• Caries risk assessment retake

• New Clinical exam (DIAGNOdent, tactile)

• New Radiograph

• Subject will receive his or her treatment according to their allocation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 3, 2024
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• 65-85 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Caries Arrested
• Caries Roots
• Caries; Dentin
• Flouride Varnish
• Heart Arrest
• Root Caries

Intervention

Drug:
• Silver Diammine Fluoride
Subjects will receive SDF around their crown margins every 6 months for next 3 years.
• Fluoride Varnishes
Subjects will receive SDF around their crown margins every 6 months for next 3 years.

Locations

Country	Name	City	State
United States	University of New England	Portland	Maine

Sponsors (1)

Lead Sponsor	Collaborator
University of New England

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	DIAGOdent: laser fluorescence to aid in the detection of caries	As the incident laser light is dispersed into the site, carious tooth structure will exhibit fluorescence, proportionate to the degree of caries, resulting in elevated scale readings on the display. Healthy tooth structure exhibits little or no fluorescence and will result in very low scale readings on the display. Over 90% accurate in detecting lesions not detectable with an explorer or bitewing X-rays. The remote display for DIAGNOdent pen uses infra-red signals, and the values are shown simultaneously on the DIAGNOdent pen and on the remote display	Every 6 month for next 3 years