Health TrialsbyHealthPanel

Oral Hygiene Assistance Training Program

ConditionsElderlyPeriodontal DiseaseGingivitisCaries,Dental
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age60+
SponsorColgate Palmolive

About this trial

This is an oral health study with a nursing home staff training program and product intervention.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Signed Informed Consent Form to receive on-site dental care and grant access to their medical and dental records, and Consent for information collection, consultation, and disease control oral healthcare treatment

Male and female subjects aged 60 years or older.

A resident of one of the nursing home sites.

ASA physical classification status of II, III, or IV (excluding high frailty scores)

Disqualifiers

Tumor(s) of the soft or hard tissues of the oral cavity.

History of allergies to oral care/personal care consumer products or their ingredients.

ASA category V patients

High frailty assessment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stannous Fluoride Toothpaste (SnF)

    Drug

    Cohort A will use a stannous fluoride toothpaste

  • sodium fluoride 5000 ppm

    Drug

    Cohort A will have the option of using a sodium fluoride 5000 ppm toothpaste if prescribed by the dentist.

  • cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash

    Drug

    Cohort A will use an antiplaque/antigingivitis mouthwash

  • sodium fluoride Mouthwash

    Drug

    Cohort A and Cohort B may use the sodium fluoride OTC mouthwash

  • Chlorhexidine 0,12%

    Drug

    Cohort A and Cohort B may use a 0.12% chlorhexidine alcohol free mouthwash

  • connected toothbrush

    Device

    Cohort B will use a u-shaped connected "smart" toothbrush

  • xylitol toothpaste

    Other intervention

    Cohort B will use a xylitol toothpaste

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Cohort AExperimental treatment 5 interventions
Group B: Cohort BExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Incidence of pneumonia

Incidence of pneumonia acquired during the study

Time frame
1 year

Secondary outcomes

1

Diabetes status

Time frame
every 3 months for 1 year
2

HbA1c value

Time frame
Every 3 months for 1 year
3

Oral Health History

Significant history of oral health

Time frame
Baseline
4

Oral Health Status

This includes plaque, calculus, stain, visible inflammation, and oral hygiene status

Time frame
Monthly for one year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Colgate Palmolive

Lead sponsor

McCoy Samples Mattingly Dental Clinic

Collaborator

FENO.Co

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: