Trial Outcomes & Findings for Evaluation of Oral Plaque Removal Utilizing an Adjunct Enzyme Pre-rinse (NCT NCT04512482)
NCT ID: NCT04512482
Last Updated: 2020-12-03
Results Overview
The composite plaque score refers to the cumulative plaque score of all twelve teeth following the administration of the bromelain and placebo (powdered sugar) solutions. The composite plaque score scale had a minimum value of 0 and a maximum value of 48. A score of 0 indicated no plaque was observed on the teeth, while a a score of 48 indicated severe plaque on all possible tooth surfaces. A lower plaque score reflects a better outcome, while a higher plaque score a worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
1 day
Results posted on
2020-12-03
Participant Flow
Subject recruitment occurred from 6/14/2018 to 7/3/2018 from the graduate orthodontic clinic in the Indiana University School of Dentistry. 46 patients were screened for eligibility during this time frame.
46 of 46 subjects were randomized. Of those, 45 subjects completed at least one of the two study interventions (one of the study arms).
Participant milestones
| Measure |
Placebo & Bromelain
Subjects were asked to chew a disclosing tablet, swish, and expectorate. Intraoral photographs were obtained. They then received a vial containing 1 gram of powdered sugar that was reconstituted with 15ml of pineapple juice at 50 degrees F. Subjects swished the solution in their mouth for 2 minutes and then expectorated. Intraoral photographs were obtained. Subjects then received a toothbrush and were asked to brush their teeth for 2 minutes. Intraoral photographs were obtained. The subjects were then given a Waterpik and instructed to use the appliances to clean their teeth and brackets to the best of their ability, for 2 minutes. Intraoral photographs were obtained.
Subjects completed a 1 week (5-9 day) washout period and then completed the protocol again but received the bromelain rinse.
|
Bromelain & Placebo
Subjects were asked to chew a disclosing tablet, swish, and expectorate. Intraoral photographs were obtained. They then received a vial containing 1 gram of bromelain that was reconstituted with 15ml of pineapple juice at 50 degrees F. Subjects swished the solution in their mouth for 2 minutes and then expectorated. Intraoral photographs were obtained. Subjects then received a toothbrush and were asked to brush their teeth for 2 minutes. Intraoral photographs were obtained. The subjects were then given a Waterpik and instructed to use the appliances to clean their teeth and brackets to the best of their ability, for 2 minutes. Intraoral photographs were obtained.
Subjects completed a 1 week (5-9 day) washout period and then completed the protocol again but received the placebo (powdered sugar).
|
|---|---|---|
|
First Intervention (1 Day)
STARTED
|
24
|
21
|
|
First Intervention (1 Day)
Baseline Plaque Assessment
|
24
|
21
|
|
First Intervention (1 Day)
Baseline Photographs
|
24
|
21
|
|
First Intervention (1 Day)
Received Rinse Intervention
|
24
|
21
|
|
First Intervention (1 Day)
Post-rinse Photographs
|
24
|
21
|
|
First Intervention (1 Day)
Toothbrush Utilization
|
24
|
21
|
|
First Intervention (1 Day)
Post-toothbrush Photographs
|
24
|
21
|
|
First Intervention (1 Day)
Waterpik Utilization
|
24
|
21
|
|
First Intervention (1 Day)
Post-Waterpik Photographs
|
24
|
21
|
|
First Intervention (1 Day)
COMPLETED
|
24
|
21
|
|
First Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Washout (1 Week)
STARTED
|
24
|
21
|
|
Washout (1 Week)
COMPLETED
|
24
|
21
|
|
Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1 Day)
STARTED
|
24
|
21
|
|
Second Intervention (1 Day)
Baseline Plaque Assessment
|
22
|
20
|
|
Second Intervention (1 Day)
Baseline Photographs
|
22
|
20
|
|
Second Intervention (1 Day)
Received Intervention
|
22
|
20
|
|
Second Intervention (1 Day)
Post-rinse Photographs
|
22
|
20
|
|
Second Intervention (1 Day)
Toothbrush Utilization
|
22
|
20
|
|
Second Intervention (1 Day)
Post-toothbrush Photographs
|
22
|
20
|
|
Second Intervention (1 Day)
Waterpik Utilization
|
22
|
20
|
|
Second Intervention (1 Day)
Post-Waterpik Photographs
|
22
|
20
|
|
Second Intervention (1 Day)
COMPLETED
|
22
|
20
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Placebo & Bromelain
Subjects were asked to chew a disclosing tablet, swish, and expectorate. Intraoral photographs were obtained. They then received a vial containing 1 gram of powdered sugar that was reconstituted with 15ml of pineapple juice at 50 degrees F. Subjects swished the solution in their mouth for 2 minutes and then expectorated. Intraoral photographs were obtained. Subjects then received a toothbrush and were asked to brush their teeth for 2 minutes. Intraoral photographs were obtained. The subjects were then given a Waterpik and instructed to use the appliances to clean their teeth and brackets to the best of their ability, for 2 minutes. Intraoral photographs were obtained.
Subjects completed a 1 week (5-9 day) washout period and then completed the protocol again but received the bromelain rinse.
|
Bromelain & Placebo
Subjects were asked to chew a disclosing tablet, swish, and expectorate. Intraoral photographs were obtained. They then received a vial containing 1 gram of bromelain that was reconstituted with 15ml of pineapple juice at 50 degrees F. Subjects swished the solution in their mouth for 2 minutes and then expectorated. Intraoral photographs were obtained. Subjects then received a toothbrush and were asked to brush their teeth for 2 minutes. Intraoral photographs were obtained. The subjects were then given a Waterpik and instructed to use the appliances to clean their teeth and brackets to the best of their ability, for 2 minutes. Intraoral photographs were obtained.
Subjects completed a 1 week (5-9 day) washout period and then completed the protocol again but received the placebo (powdered sugar).
|
|---|---|---|
|
Second Intervention (1 Day)
Protocol Violation
|
2
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo & Bromelain
n=24 Participants
Subjects were asked to chew a disclosing tablet, swish, and expectorate. Intraoral photographs were obtained. They then received a vial containing 1 gram of powdered sugar (placebo) that was reconstituted with 15ml of pineapple juice at 50 degrees F. Subjects swished the solution in their mouth for 2 minutes and then expectorated. Intraoral photographs were obtained. Subjects then received a toothbrush and were asked to brush their teeth for 2 minutes. Intraoral photographs were obtained. The subjects were then given a Waterpik and instructed to use the appliances to clean their teeth and brackets to the best of their ability, for 2 minutes. Intraoral photographs were obtained.
Subjects then had a 1 week (5-9 day) washout period and were then exposed to the other intervention (bromelain rinse).
|
Bromelain & Placebo
n=21 Participants
Subjects were asked to chew a disclosing tablet, swish, and expectorate. Intraoral photographs were obtained. They then received a vial containing 1 gram of bromelain that was reconstituted with 15ml of pineapple juice at 50 degrees F. Subjects swished the solution in their mouth for 2 minutes and then expectorated. Intraoral photographs were obtained. Subjects then received a toothbrush and were asked to brush their teeth for 2 minutes. Intraoral photographs were obtained. The subjects were then given a Waterpik and instructed to use the appliances to clean their teeth and brackets to the best of their ability, for 2 minutes. Intraoral photographs were obtained.
Subjects then had a 1 week (5-9 day) washout period and were then exposed to the other intervention (placebo rinse).
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
19 Participants
n=24 Participants
|
16 Participants
n=21 Participants
|
35 Participants
n=45 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=24 Participants
|
5 Participants
n=21 Participants
|
10 Participants
n=45 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=24 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=45 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=24 Participants
|
12 Participants
n=21 Participants
|
25 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=24 Participants
|
9 Participants
n=21 Participants
|
20 Participants
n=45 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 1 dayThe composite plaque score refers to the cumulative plaque score of all twelve teeth following the administration of the bromelain and placebo (powdered sugar) solutions. The composite plaque score scale had a minimum value of 0 and a maximum value of 48. A score of 0 indicated no plaque was observed on the teeth, while a a score of 48 indicated severe plaque on all possible tooth surfaces. A lower plaque score reflects a better outcome, while a higher plaque score a worse outcome.
Outcome measures
| Measure |
Bromelain
n=43 Participants
Subjects were asked to chew a disclosing tablet, swish, and expectorate. Intraoral photographs were obtained. They then received a vial containing 1 gram of bromelain that was reconstituted with 15ml of pineapple juice at 50 degrees F. Subjects swished the solution in their mouth for 2 minutes and then expectorated. Intraoral photographs were obtained. Subjects then received a toothbrush and were asked to brush their teeth for 2 minutes. Intraoral photographs were obtained. The subjects were then given a Waterpik and instructed to use the appliances to clean their teeth and brackets to the best of their ability, for 2 minutes. Intraoral photographs were obtained.
Bromelain: The subjects were randomized to either receive the bromelain pre-rinse or the powdered sugar placebo pre-rinse. Subjects then had a 5-9 day washout period and was then exposed to the other intervention.
|
Placebo
n=43 Participants
Subjects were asked to chew a disclosing tablet, swish, and expectorate. Intraoral photographs were obtained. They then received a vial containing 1 gram of powdered sugar that was reconstituted with 15ml of pineapple juice at 50 degrees F. Subjects swished the solution in their mouth for 2 minutes and then expectorated. Intraoral photographs were obtained. Subjects then received a toothbrush and were asked to brush their teeth for 2 minutes. Intraoral photographs were obtained. The subjects were then given a Waterpik and instructed to use the appliances to clean their teeth and brackets to the best of their ability, for 2 minutes. Intraoral photographs were obtained.
Powdered sugar: The subjects were randomized to either receive the bromelain pre-rinse or the powdered sugar placebo pre-rinse. Subjects then had a 5-9 day washout period and was then exposed to the other intervention.
|
|---|---|---|
|
Composite Plaque Score
|
36.2 score on a scale
Standard Deviation 10.7
|
37.9 score on a scale
Standard Deviation 10.8
|
Adverse Events
Bromelain
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Kelton T. Stewart, Department Chair
Indiana University School of Dentistry, Department of Orthodontics
Phone: 317-278-1087
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place