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Trial record 69 of 1201 for:    tooth decay

Older Adult Effectiveness of 2 Treatments

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ClinicalTrials.gov Identifier: NCT03916926
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Suchitra Nelson, Case Western Reserve University

Brief Summary:

The study is a cluster randomized clinical trial (RCT) to be conducted in 22 publicly subsidized housing facilities/sites (HUD Section 202) and other low-income housing voucher programs in NE Ohio. The facilities will be randomized to 2 arms: Arm 1 (11 sites) - Participants will receive biannual silver diamine fluoride (SDF) versus Arm 2 (11 sites): Participants will receive atraumatic restorative treatment (ART) with glass ionomer cement (GIC) + biannual fluoride varnish (FV) application. A total of 550 participants (Arm 1: 275, Arm 2: 275) will be followed for one year (baseline, 26 weeks, 52 weeks).

The protocol for each arm will address both coronal and root surface tooth decay lesions: Arm 1: The treatment will be bi-annual topical 38% SDF(Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL) following manufacturer's instructions and published guidelines; Arm 2: The treatment will be ART will be a modification where the cavity will be restored with high viscosity glass-ionomer cement (GIC) (GC Fuji Automix LC Resin Reinforced Glass Ionomer Restorative, Japan)). Patients will also receive biannual topical fluoride varnish treatments (FluoriMax, Elevate) according to manufacturer's instructions.


Condition or disease Intervention/treatment Phase
Dental Caries Device: A "simple medical strategy" consisting of silver diamine fluoride (SDF) Device: B "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride varnish (FV) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The comparative effectiveness of "simple medical", i.e. SDF versus "typical dental", i.e. atraumatic restorative treatment (ART) + fluoride varnish (FV) intervention in this study is focused on the person level to address the unique oral health needs of low-income older adults.

The interventions proposed for this study are in current clinical use. Both coronal and root surface tooth decay lesions will be treated. The two evidence-based strategies in older adults will be compared as follows:

Arm 1 (N=225 participants): A "simple medical strategy" consisting of SDF versus Arm 2 (N=225 participants): A "typical dental strategy" consisting of ART + FV

Masking: Single (Participant)
Masking Description:

We will attempt blinding of participants to the study group (participants). The hygienists (care providers) will be unaware of the treatment assignment when they go to their respective housing facilities. For all treatment visits, assessments will be conducted prior to the intervention delivery.

Two hygienists will go to the housing facility randomized to the SDF arm and the other two will go to the ART + FV arm. The baseline treatment to be applied will be revealed only after the baseline caries exam has been completed. At the 6 month follow-up visit, the two hygienists that applied SDF will now go to the facilities randomized to the ART + FV facilities and vice-versa to conduct the 6-month follow up caries assessment exam and treatment. We will follow similarly for the 12-moth follow-up visit. By this strategy, we will make sure that potential bias of the hygienist evaluating their own work is minimized.

Primary Purpose: Treatment
Official Title: Reducing Oral Health Disparities of Older Adults: Comparative Effectiveness of 2 Treatments
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A "simple medical strategy" consisting of SDF
The treatment will be bi-annual application (at baseline and 26 weeks) of topical 38% silver diamine fluoride (Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL) following manufacturer's instructions and guidelines published by UCSF (2016).
Device: A "simple medical strategy" consisting of silver diamine fluoride (SDF)
Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL)
Other Name: SDF treatment

Active Comparator: A "typical dental strategy" consisting of ART + FV
Atraumatic Restorative Treatment (ART) will be a modification of the approach used by Lo and colleagues (2006), and the cavity restored at baseline with resin reinforced glass-ionomer cement (GIC) (GC Corporation, Japan). Participants in this arm will also receive biannual topical fluoride varnish application (FluoriMax, Elevate) according to manufacturer's instructions.
Device: B "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride varnish (FV)
GC Fuji (for ART) and FluoriMax Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL (for FV)
Other Name: ART + FV treatment




Primary Outcome Measures :
  1. caries arrest [ Time Frame: Change between baseline and 26 weeks ]
    Number of caries lesions arrested will be assessed through the International Caries Assessment and Detection System (ICDAS) conducted by calibrated examiners

  2. caries arrest [ Time Frame: Change between baseline and 52 weeks ]
    Number of caries lesions arrested will be assessed through the International Caries Assessment and Detection System (ICDAS) conducted by calibrated examiners

  3. tooth pain and hypersensitivity [ Time Frame: Assessed as change between baseline and 26 weeks ]
    Frequency of pain from PROMIS pain intensity measure (3 items, likert scale going from 0 to 4, higher score more pain); Hypersensitivity from the Dental Discomfort Questionnaire (2 items, likert scale going from 0 to 2, higher score more discomfort).

  4. tooth pain and hypersensitivity [ Time Frame: Assessed as change between baseline and 52 weeks ]
    Frequency of pain from PROMIS pain intensity measure (3 items, likert scale going from 0 to 4, higher score more pain); Hypersensitivity from the Dental Discomfort Questionnaire (2 items, likert scale going from 0 to 2, higher score more discomfort).


Secondary Outcome Measures :
  1. prevention of new decay [ Time Frame: Change in decay between baseline and 26 weeks ]
    number of new cavitated lesions on permanent teeth using ICDAS exam

  2. prevention of new decay [ Time Frame: Change in decay between baseline and 52 weeks ]
    number of new cavitated lesions on permanent teeth using ICDAS exam

  3. oral health quality of life: Participant questionnaire [ Time Frame: Change in score from baseline to 26 weeks ]
    The Geriatric Oral Health Quality of Life questionnaire measures participants difficulty in chewing, swallowing, appearance with teeth. Overall mean score from a 12 item Likert scale going from 1 to 3. Higher score better quality of life.

  4. oral health quality of life: Participant questionnaire [ Time Frame: Change in score from baseline to 52 weeks ]
    The Geriatric Oral Health Quality of Life questionnaire measures participants difficulty in chewing, swallowing, appearance with teeth. Overall mean score from a 12 item Likert scale going from 1 to 3. Higher score better quality of life.



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Ages Eligible for Study:   62 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provide signed and dated informed consent form
  • Willing to comply with all study procedures and be available for the duration of the study (1 year)
  • Male or female, aged 62 years or older
  • Live in a participating older adult housing facility to continue in the clinical trial phase of the study, an individual must:
  • Have at least one untreated active root or coronal carious lesion with ICDAS-II (2015) lesion severity code of 3 or greater

Exclusion Criteria:

  • Sensitivity to silver or other heavy-metal ions
  • Those with ulcerative gingivitis or stomatitis
  • Serious life-threatening medical disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916926


Contacts
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Contact: Suchitra S. Nelson, PhD (216) 368-3469 sxn15@case.edu
Contact: Shelley Curtan, MA (216)368-3968 sgc36@case.edu

Locations
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United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Western Reserve University
Patient-Centered Outcomes Research Institute

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Responsible Party: Suchitra Nelson, Professor and Interim Chair, Department of Community Dentistry, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT03916926     History of Changes
Other Study ID Numbers: AD-2018-C1-10590
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Suchitra Nelson, Case Western Reserve University:
Dental Caries
Oral Health Quality of Life

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs