Trial Outcomes & Findings for Exploratory Study on Effect of Whitening Agent With Emulsion Gel in Xerostomic Population (NCT NCT04996069)

Last Updated: 2024-07-26

Results Overview

At both study visits, subjects will be asked to complete a visual analog scale (VAS) before and after the application of the study product to establish a self-reported subjective perception of the oral cavity. The scale ranges from 0 to 10 and the higher the score indicates the more Xerostomic the subject.

Recruitment status

COMPLETED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

visit 1 and visit 2 pre and post product application on Day 1 and day 7

Results posted on

2024-07-26

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants This is a single arm study. All subjects enrolled will be apart of the experimental group. Subjects in this group will use Crest Whitening Emulsions on their teeth up to 4 times a day for 7 days in order for the study team to evaluate if the study intervention product increases saliva production in this Xerostomic population. Crest Whitening Emulsions: Subjects with Xerostomia will be asked to apply the study intervention product to their teeth up to 4 times per day for 1 week to investigate if the study intervention product increases saliva production in this dry mouth populaiton.
Overall Study STARTED	25
Overall Study Completion of the Study	25
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One subject had more unstimulated saliva than .18 ml/min at baseline and was not included in the analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=25 Participants This is a single arm study. All subjects enrolled will be apart of the experimental group. Subjects in this group will use Crest Whitening Emulsions on their teeth up to 4 times a day for 7 days in order for the study team to evaluate if the study intervention product increases saliva production in this Xerostomic population. Crest Whitening Emulsions: Subjects with Xerostomia will be asked to apply the study intervention product to their teeth up to 4 times per day for 1 week to investigate if the study intervention product increases saliva production in this dry mouth populaiton.
Age, Continuous	58 years n=5 Participants • One subject had more unstimulated saliva than .18 ml/min at baseline and was not included in the analysis.
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants
Salivary flow	.067 ml/min STANDARD_DEVIATION .063 • n=5 Participants

PRIMARY outcome

Timeframe: visit 1 and visit 2 pre and post product application on Day 1 and day 7

Population: unstimulated salivary flow below 0.18 ml/min at the baseline

Outcome measures

Outcome measures
Measure	Exploratory Study on Effect of Whitening (Agent) With Emulsion on Xerostomic Population. n=24 Participants medication induced xerostomic population with unstimulated salivary flow below 0.18ml/min	Second/Final Visit +/- 7 Days n=24 Participants The same as visit one and pre questions
Subjective Perception of Mouth Dryness Subjective perception prior to product application	6.92 units on a scale Standard Deviation 1.53	6.46 units on a scale Standard Deviation 2.62
Subjective Perception of Mouth Dryness Subjective perception after the product application	4.21 units on a scale Standard Deviation 2.50	3.46 units on a scale Standard Deviation 2.54

SECONDARY outcome

Timeframe: visit 1 and visit 2 pre and post saliva production in day 1 and day 7

For the objective measurement of the improvement of the saliva production; subjects will be asked to drool into a pre-weighed vial for 5 minutes before application of the study product and again after application at both visits. The difference in weight will be calculated to evaluate what effectiveness the study product may have in saliva production

Outcome measures

Outcome measures
Measure	Exploratory Study on Effect of Whitening (Agent) With Emulsion on Xerostomic Population. n=24 Participants medication induced xerostomic population with unstimulated salivary flow below 0.18ml/min	Second/Final Visit +/- 7 Days The same as visit one and pre questions
Change in Saliva Production Measured in ml/Min Post product application salivary flow (Day 1) ml/min	0.19 mL/Min Standard Deviation 0.08	—
Change in Saliva Production Measured in ml/Min Pre product application salivary flow (Day 1) ml/min	0.06 mL/Min Standard Deviation 0.08	—
Change in Saliva Production Measured in ml/Min Pre product application salivary flow (Day 7) ml/min	0.14 mL/Min Standard Deviation 0.21	—
Change in Saliva Production Measured in ml/Min Post product application salivary flow (Day 7) ml/min	0.21 mL/Min Standard Deviation 0.33	—

SECONDARY outcome

Timeframe: 7 days between visit 1 and visit 2

At both study visits, subjects will be asked to complete a visual analog scale to establish if there is a difference between self-reported sensitivity. The scale ranges from 0 to 10 and the higher the score indicates the more sensitive the subject's teeth.

Outcome measures

Outcome measures
Measure	Exploratory Study on Effect of Whitening (Agent) With Emulsion on Xerostomic Population. n=24 Participants medication induced xerostomic population with unstimulated salivary flow below 0.18ml/min	Second/Final Visit +/- 7 Days n=24 Participants The same as visit one and pre questions
Perceived Sensitivity of Teeth Between Visit 1 and 2 Pre product application (sensitivity of teeth)	3.61 units on a scale Standard Deviation 3.46	3.72 units on a scale Standard Deviation 3.33
Perceived Sensitivity of Teeth Between Visit 1 and 2 Post Product application (sensitivity of teeth)	2.30 units on a scale Standard Deviation 3.14	1.56 units on a scale Standard Deviation 2.7

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mabi Singh

Tufts University School of Dental Medicine

Phone: 6176363931

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place