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OTC Oral Care Products for Oral Health

N/A
Recruiting
Led By Dr. Petra Wilder-Smith
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trialwill research better ways to measure and improve oral health, by taking pictures of mouths and studying the effects of toothpastes and mouthwashes. Volunteers will use products for up to 6 months and be monitored for plaque, gum health and saliva.

Who is the study for?
This trial is for adults over 18 in good health who want to help find better ways to measure oral health using images. It's not for those with allergies or intolerances to toothpaste and mouthwash.Check my eligibility
What is being tested?
The study tests how well different over-the-counter toothpastes and mouthrinses improve dental plaque control, gum health, and saliva production, using photos and imaging software.See study design
What are the potential side effects?
Since the trial involves common OTC toothpastes or mouthrinses, side effects might include typical reactions like mouth irritation but are generally expected to be minimal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gingival health (gingival index) at Month 1
Gingival health (gingival index) at Month 3
Gingival health (gingival index) at Month 6
+9 more

Trial Design

7Treatment groups
Active Control
Group I: Brushing with LivFresh Dental GelActive Control1 Intervention
Subjects will brush twice daily for the study duration with LivFresh Dental Gel with a standard Oral B ProFlexR toothbrush and will be trained in standard sulcular brushing technique. Subjects will brush their teeth two hours prior to each visit and refrain from eating from that time onwards until after their visit. Plaque levels, gingival inflammation, and sulcus bleeding will be recorded. A standardized periodontal probe will be used to measure pockets. Subjects will expectorate into a graduated cylinder for 5 minutes and their saliva production will be measured. Saliva will not be stored or analyzed in any way. Subjects will be photographed and evaluated on all study dates by the same blinded, pre-calibrated investigator. Photographs will be recorded using a standard dental intraoral camera, which only records intraoral images. These photos will not show the subject's face but will focus on the subject's mouth.
Group II: Brushing with LivFree Dental GelActive Control1 Intervention
Subjects will brush twice daily for the study duration with LivFree Dental Gel with a standard Oral B ProFlexR toothbrush and will be trained in standard sulcular brushing technique. Subjects will brush their teeth two hours prior to each visit and refrain from eating from that time onwards until after their visit. Plaque levels, gingival inflammation, and sulcus bleeding will be recorded. A standardized periodontal probe will be used to measure pockets. Subjects will expectorate into a graduated cylinder for 5 minutes and their saliva production will be measured. Saliva will not be stored or analyzed in any way. Subjects will be photographed and evaluated on all study dates by the same blinded, pre-calibrated investigator. Photographs will be recorded using a standard dental intraoral camera, which only records intraoral images. These photos will not show the subject's face but will focus on the subject's mouth.
Group III: Brushing with AIM Dental GelActive Control1 Intervention
Subjects will brush twice daily for the study duration with AIM Dental Gels with a standard Oral B ProFlexR toothbrush and will be trained in standard sulcular brushing technique. Subjects will brush their teeth two hours prior to each visit and refrain from eating from that time onwards until after their visit. Plaque levels, gingival inflammation, and sulcus bleeding will be recorded. A standardized periodontal probe will be used to measure pockets. Subjects will expectorate into a graduated cylinder for 5 minutes and their saliva production will be measured. Saliva will not be stored or analyzed in any way. Subjects will be photographed and evaluated on all study dates by the same blinded, pre-calibrated investigator. Photographs will be recorded using a standard dental intraoral camera, which only records intraoral images. These photos will not show the subject's face but will focus on the subject's mouth.
Group IV: Brushing with Crest Prohealth Dental GelActive Control1 Intervention
Subjects will brush twice daily for the study duration with Crest Prohealth Dental Gel with a standard Oral B ProFlexR toothbrush and will be trained in standard sulcular brushing technique. Subjects will brush their teeth two hours prior to each visit and refrain from eating from that time onwards until after their visit. Plaque levels, gingival inflammation, and sulcus bleeding will be recorded. A standardized periodontal probe will be used to measure pockets. Subjects will expectorate into a graduated cylinder for 5 minutes and their saliva production will be measured. Saliva will not be stored or analyzed in any way. Subjects will be photographed and evaluated on all study dates by the same blinded, pre-calibrated investigator. Photographs will be recorded using a standard dental intraoral camera, which only records intraoral images. These photos will not show the subject's face but will focus on the subject's mouth.
Group V: Brushing with Parodontax Dental GelActive Control1 Intervention
Subjects will brush twice daily for the study duration with Parodontax Dental Gel with a standard Oral B ProFlexR toothbrush and will be trained in standard sulcular brushing technique. Subjects will brush their teeth two hours prior to each visit and refrain from eating from that time onwards until after their visit. Plaque levels, gingival inflammation, and sulcus bleeding will be recorded. A standardized periodontal probe will be used to measure pockets. Subjects will expectorate into a graduated cylinder for 5 minutes and their saliva production will be measured. Saliva will not be stored or analyzed in any way. Subjects will be photographed and evaluated on all study dates by the same blinded, pre-calibrated investigator. Photographs will be recorded using a standard dental intraoral camera, which only records intraoral images. These photos will not show the subject's face but will focus on the subject's mouth.
Group VI: Brushing with Colgate Total Dental GelActive Control1 Intervention
Subjects will brush twice daily for the study duration with Colgate Total Dental Gel with a standard Oral B ProFlexR toothbrush and will be trained in standard sulcular brushing technique. Subjects will brush their teeth two hours prior to each visit and refrain from eating from that time onwards until after their visit. Plaque levels, gingival inflammation, and sulcus bleeding will be recorded. A standardized periodontal probe will be used to measure pockets. Subjects will expectorate into a graduated cylinder for 5 minutes and their saliva production will be measured. Saliva will not be stored or analyzed in any way. Subjects will be photographed and evaluated on all study dates by the same blinded, pre-calibrated investigator. Photographs will be recorded using a standard dental intraoral camera, which only records intraoral images. These photos will not show the subject's face but will focus on the subject's mouth.
Group VII: Rinsing with Lumineux or Listerine MouthwashesActive Control1 Intervention
Subjects will be asked to rinse twice daily with 1 capful for 1 minute with Lumineux or Listerine Mouthwashes directly after brushing their teeth, while continuing with their usual oral hygiene protocol. Plaque levels, gingival inflammation, and sulcus bleeding will be recorded. A standardized periodontal probe will be used to measure pockets. Subjects will expectorate into a graduated cylinder for 5 minutes and their saliva production will be measured. Saliva will not be stored or analyzed in any way. Subjects will be photographed and evaluated on all study dates by the same blinded, pre-calibrated investigator. Photographs will be recorded using a standard dental intraoral camera, which only records intraoral images. These photos will not show the subject's face but will focus on the subject's mouth.

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor
543 Previous Clinical Trials
1,922,726 Total Patients Enrolled
Dr. Petra Wilder-SmithPrincipal InvestigatorBeckman Laser Institute University of California Irvine
1 Previous Clinical Trials
200 Total Patients Enrolled

Media Library

OTC Toothpastes or Mouthrinses Clinical Trial Eligibility Overview. Trial Name: NCT05470023 — N/A
Gum Disease Research Study Groups: Brushing with LivFresh Dental Gel, Brushing with LivFree Dental Gel, Brushing with AIM Dental Gel, Brushing with Crest Prohealth Dental Gel, Brushing with Parodontax Dental Gel, Brushing with Colgate Total Dental Gel, Rinsing with Lumineux or Listerine Mouthwashes
Gum Disease Clinical Trial 2023: OTC Toothpastes or Mouthrinses Highlights & Side Effects. Trial Name: NCT05470023 — N/A
OTC Toothpastes or Mouthrinses 2023 Treatment Timeline for Medical Study. Trial Name: NCT05470023 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research protocol still accept enrollees?

"Per clinicaltrials.gov, this trial is currently seeking applicants and has been updated recently on the 11th of November 2022, after first being posted on September 1st 2021."

Answered by AI

Are there any limitations on the number of participants this research program is accepting?

"Affirmative. According to clinicaltrials.gov, this medical project is actively seeking enrollees and was initially published on September 1st 2022 with the most recent update registered at November 1st 2022. The trial requires a total of 275 volunteers from one location."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Beckman Laser Institute and Medical Clinic
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Beckman Laser Institute and Medical Clinic: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
Acta Odontologica ScandinavicaJournal
Periodontal Disease in Pregnancy I. Prevalence and Severity
Löe, Harald, and John Silness. 1963. “Periodontal Disease in Pregnancy I. Prevalence and Severity”. Acta Odontologica Scandinavica. Informa UK Limited. doi:10.3109/00016356309011240.
clinicaltrials.govStudy
Imaging-based Assessment of Oral Biofilm and Gingival Health
Petra E. Wilder-Smith 2022. "Imaging-based Assessment of Oral Biofilm and Gingival Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05470023.
~167 spots leftby Dec 2026
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