Clinical trial NCT04255251: Effectiveness Silver Diamine Fluoride Versus Sodium Fluoride in Arresting Caries Around Crown Margins in Older Adults
Official title: Effectiveness Silver Diamine Fluoride Versus Sodium Fluoride in Arresting Caries Around Crown Margins in Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Caries Roots
Flouride Varnish
Caries; Dentin
Caries Arrested
Lead sponsor: University of New England
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned randomly into treatment and control group using a predetermined randomization protocol.
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Tactile exam to evaluate extend of caries around tooth margin
timeFrame: Every 6 month for next 3 years
Secondary outcomes:
measure: DIAGOdent: laser fluorescence to aid in the detection of caries
timeFrame: Every 6 month for next 3 years
Other outcomes:
Locations:
city: Portland
country: United States
facility: University of New England
state: Maine
Study officials:
References:
citation: 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.
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.