Trial Outcomes & Findings for DryShield vs Cotton Roll Isolation During Sealants Placement: Efficiency and Patient Preference (NCT NCT02995369)
NCT ID: NCT02995369
Last Updated: 2023-01-20
Results Overview
The time for sealant application was recorded with a stopwatch by the dental assistant as follows for the techniques: the insertion of the first isolation aid (CRI or DS) in the oral cavity constituted the start time, and the end time was when the corresponding isolation aid (CRI or DS) was removed from the oral cavity after the sealants application.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Initial insertion of isolation aid (CRI or DS) and removal of corresponding isolation aid (CRI or DS)
Results posted on
2023-01-20
Participant Flow
Study participants were selected from pediatric patients who presented to one of the four Montefiore pediatric dental clinics for an intake or a recall visit and who were determined to benefit from sealants application, or from patients who present solely for a sealant application appointment, when their examination was done at a previous date (within 6 months).
Participant milestones
| Measure |
Cotton Roll Isolation (Left) First, Then Dryshield Isolation (Right)
Group (1) Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using Dryshield (DS) on the right side.
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.
The four arms/groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.
|
Cotton Roll Isolation (Right) First, Then Dryshield Isolation (Left)
Group (2) Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using Dryshield (DS) on the left side.
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.
The four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.
|
Dryshield Isolation (Left) First, Then Cotton Roll Isolation (Right)
Group (3) Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using cotton rolls (CRI) on the right side.
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.
The four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.
|
Dryshield Isolation (Right) First, Then Cotton Roll Isolation (Left)
Group (4) Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using cotton rolls (CRI) on the left side.
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.
The four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cotton Roll Isolation (Left) First, Then Dryshield Isolation (Right)
n=8 Participants
Group (1) Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using Dryshield (DS) on the right side.
The four arms/groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.
|
Cotton Roll Isolation (Right) First, Then Dryshield Isolation (Left)
n=8 Participants
Group (2) Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using Dryshield (DS) on the left side.
The four arms/groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.
|
Dryshield Isolation (Left) First, Then Cotton Roll Isolation (Right)
n=8 Participants
Group (3) Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using cotton rolls (CRI) on the right side.
The four arms/groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.
|
Dyshield Isolation (Right) First, Then Cotton Roll Isolation (Left)
n=8 Participants
Group (4) Dryshield (DS) was be used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using cotton rolls (CRI) on the left side.
The four arms/groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
8.6 years
n=8 Participants
|
8.6 years
n=8 Participants
|
8.8 years
n=8 Participants
|
8.5 years
n=8 Participants
|
8.6 years
n=32 Participants
|
|
Sex/Gender, Customized
Unknown
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
32 Participants
n=32 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
8 participants
n=8 Participants
|
8 participants
n=8 Participants
|
8 participants
n=8 Participants
|
8 participants
n=8 Participants
|
32 participants
n=32 Participants
|
PRIMARY outcome
Timeframe: Initial insertion of isolation aid (CRI or DS) and removal of corresponding isolation aid (CRI or DS)Population: Results were analyzed and reported based on the sequence the interventions were administered.
The time for sealant application was recorded with a stopwatch by the dental assistant as follows for the techniques: the insertion of the first isolation aid (CRI or DS) in the oral cavity constituted the start time, and the end time was when the corresponding isolation aid (CRI or DS) was removed from the oral cavity after the sealants application.
Outcome measures
| Measure |
Cotton Roll Isolation (Left)
n=16 Participants
Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using Dryshield (DS) on the opposite side.
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.
|
Cotton Roll Isolation (Right)
n=16 Participants
Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using Dryshield (DS) on the opposite side.
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.
|
Dryshield Isolation (Left)
n=16 Participants
Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side.
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.
|
Dryshield Isolation (Right)
n=16 Participants
Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side.
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.
|
|---|---|---|---|---|
|
Placement Time of Sealants Using Dryshield (DS) vs Cotton Rolls (CRI)
|
164.88 Seconds
Standard Deviation 28.78
|
160.50 Seconds
Standard Deviation 26.00
|
164.56 Seconds
Standard Deviation 27.72
|
167.81 Seconds
Standard Deviation 28.92
|
PRIMARY outcome
Timeframe: Immediately after the dental procedure is completed, up to 30 minutesPopulation: All 32 participants who were enrolled into the study were queried for their preference (CRI vs DS). Only 8 participants per group analyzed (instead of 16 as in the other Primary Outcome Measure) as the survey was only administered once per participant.
Right after the procedure, participants completed a verbal survey. The survey consisted of seven closed-ended questions intended to assess the participants' opinion on things such as comfort, noise, taste, and tissue stretching. Some survey questions require a YES or NO answer (i.e. Did you taste any of the materials used?). Other questions required the participant to select CRI or DS (i.e. Which system was the most comfortable?). The pediatric dental attending asked each patient each question, in the same sequence. Patient preferences were assessed with Question number 4, which specifically asked " If we did the procedure again, which system would you prefer?" The options were the Cotton Roll Isolation (CRI) or the Dryshield (DS) system. The reported values represents the response to Question number 4.
Outcome measures
| Measure |
Cotton Roll Isolation (Left)
n=8 Participants
Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using Dryshield (DS) on the opposite side.
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.
|
Cotton Roll Isolation (Right)
n=8 Participants
Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using Dryshield (DS) on the opposite side.
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.
|
Dryshield Isolation (Left)
n=8 Participants
Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side.
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.
|
Dryshield Isolation (Right)
n=8 Participants
Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side.
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.
|
|---|---|---|---|---|
|
Patient Preference as Assessed by Verbal Self-report Survey
Cotton Roll Isolation (CRI)
|
7 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
|
Patient Preference as Assessed by Verbal Self-report Survey
Dryshield (DS)
|
1 Participants
|
4 Participants
|
3 Participants
|
7 Participants
|
Adverse Events
Cotton Roll Isolation (Left)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cotton Roll Isolation (Right)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dryshield Isolation (Left)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dryshield Isolation (Right)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place