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

NCT ID: NCT04255251

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-26
• Study Completion Date: 2024-01-03

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.

Detailed 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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Silver Diammine Fluoride

Intervention Type: DRUG

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

Fluoride varnish group

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

Group Type: ACTIVE_COMPARATOR

Fluoride Varnishes

Intervention Type: DRUG

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

Interventions

Silver Diammine Fluoride

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

Intervention Type: DRUG

Fluoride Varnishes

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of New England

OTHER

Sponsor Role: lead

Responsible Party

Shaista Rashid

Assistant Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of New England

Portland, Maine, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

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

Role: CONTACT

srashid2@une.edu

2072214861

Mohamed ElSalhy, MPH, PHD

Role: CONTACT

melsalhy@une.edu

2072214862

Facility Contacts

SHAISTA RASHID, D.D.S

Role: primary

srashid2@une.edu

207-221-4861

References

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.

Reference Type: BACKGROUND

PMID: 28888414 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31299955 (View on PubMed)

Other Identifiers

Universityof New Engalnd

Identifier Type: -

Identifier Source: org_study_id