LOMA LINDA UNIVERSITY, School of Dentistry
Loma Linda, California, 92350, United States
NCT Number: NCT05768373
The goal of this clinical trial is to evaluate the effect of 3M™ Clinpro™ Fluoride Aqueous Solution (experimental) on Dentin Hypersensitivity (DHS) in comparison to 3M™ Vanish™ (commercialized, control] in patients who have DHS.
Participants will be asked to complete the following activities:
Undergo a pre-treatment washout period for 3- to 6-weeks (± 4 days) post-enrollment. During this time, the Subject is to only use the provided oral hygiene products.
Hypersensitivity will be assessed prior to (baseline) and immediately after sample application.
Subject will be asked to come to the facility for hypersensitivity assessments at 24 hours, 7 days, and 30 days after the treatment visit.
Researchers will compare 3M™ Clinpro™ Fluoride Aqueous Solution to 3M™ Vanish™ to evaluate if the effect of Clinpro™ on DHS treatment is non-inferior to Vanish™.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Loma Linda, California, 92350, United States
After Informed Consent has been obtained, the subjects will be given study supplied oral hygiene products (e.g., toothbrush and toothpaste) to be used immediately after the consent visit and throughout the entire duration of the study.
Subjects will have a minimum wash-out period of 3 weeks followed by 1 treatment visit. At the treatment visit, a pain assessment will be performed (ie, a baseline pain score) in response to both an air-blast stimulus and tactile stimulus. After each stimulus, the Subject should score their pain using a Visual Analog Scale (VAS).
After recording baseline pain scores, Clinpro™ (Treatment arm) or Vanish™ (Control arm) will be applied according to the manufacturer's IFU. Pain in response to air blast and probe test will be assessed using VAS immediately after application of fluoride treatment (within 15 minutes). Pain response will be assessed again at 24 h, 7 d, 21 d and 30 d post-application of the treatment.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individual teeth may not be included that meet any of the following criteria:
Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.
Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.
Time frame: Base line and immediately after application (within 15 minutes post-treatment).
Change in sensitivity as assessed using a Visual Analog Scale (VAS, 0 - 100 mm) immediately after exposure to air stimulus relative to baseline.
The VAS consists of a 100mm line, with two extremes being 0 mm (no pain) and 100 mm (worst pain). Higher scores mean a worse outcome.
Time frame: Baseline and 24 hours post-treatment
This is a co-primary endpoint
Change in sensitivity as assessed using 100-mm Visual Analog Score (VAS) 24 hours after exposure to air stimulus relative to baseline.
The VAS consists of a 100mm line, with two extremes being 0 mm (no pain) and 100 mm (worst pain). Higher scores mean a worse outcome.
Time frame: Baseline and 7 days post-treatment
Change in sensitivity as assessed using 100-mm Visual Analog Score (VAS) 7 days after exposure to air stimulus relative to baseline.
The VAS consists of a 100mm line, with two extremes being 0 mm (no pain) and 100 mm (worst pain). Higher scores mean a worse outcome.
Time frame: Baseline and 21 days post-treatment
Change in sensitivity as assessed using 100-mm Visual Analog Score (VAS) 21 days after exposure to air stimulus relative to baseline.
The VAS consists of a 100mm line, with two extremes being 0 mm (no pain) and 100 mm (worst pain). Higher scores mean a worse outcome.
Time frame: Baseline and 30 days post-treatment
Change in sensitivity as assessed using 100-mm Visual Analog Score (VAS) 30 days after exposure to air stimulus relative to baseline.
The VAS consists of a 100mm line, with two extremes being 0 mm (no pain) and 100 mm (worst pain). Higher scores mean a worse outcome.
Solventum US LLC
Industry
Clinical Evaluation of Clinpro™ 2.1% Sodium Fluoride Aqueous Solution in the Treatment of Dentin Hypersensitivity
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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