Patient Preference, Time
Conditions
Keywords
Sealants, Dryshield, Cotton roll, Isolation, Efficiency, Preference
Brief summary
The goals of this study are to determine if 1) placement times of pit and fissure sealants using the DryShield system differ from those when using the cotton roll isolation technique; and 2) there is a significant difference in patient preference between Dryshield and the cotton roll technique.
Detailed description
Pit and fissure caries account for 80 to 90 percent of all caries in permanent posterior teeth. Pit-and-fissure sealants can be used effectively to prevent caries. By micromechanically bonding to the teeth, they provide a physical barrier that keeps microorganisms and food particles from collecting in susceptible pits and fissures, thus preventing caries initiation and arresting caries progression. The effectiveness of sealants for caries prevention depends on long-term retention, which is largely a function of meticulousness of application: keeping the tooth surface free from saliva contamination during application and polymerization is critical. Low retention of sealants has been attributed to insufficient moisture control. Therefore, proper isolation of the teeth is one of the most important steps when placing sealants to ensure their retention. Cotton roll isolation (CRI) has been widely used for sealant placement, and is the most common method among pediatric dentists. Although very effective, CRI can be a challenging technique especially when used in young children: the cotton rolls can be cumbersome for both the patient and the clinician. A previous study demonstrated that new moisture control systems such as Isolite, produce sealant retention rates comparable to cotton roll isolation, while decreasing procedure time. DryShield (DS) has recently been introduced as an all-in-one isolation system. It is similar to the Isolite as it combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block, but differs in that it's autoclavable and does not provide illumination. Its design allows it to suction and isolate half the oral cavity at a time. Therefore, it should presumably facilitate sealants placement under a more controlled environment, while reducing chair time for the dentist. The goals of this study are to determine if 1) placement times of pit and fissure sealants using the DryShield system differ from those when using the cotton roll isolation technique; and 2) there is a significant difference in patient preference between DryShield and the cotton roll technique.
Interventions
DEVICEDryShield
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.
OTHERCotton 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 is used.
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
The target population will include healthy, cognitively normal patients who present to one of the Montefiore pediatric dental clinics for an intake or a recall visit who are determined to benefit from sealants application, or patients who present solely for a sealant application appointment, when their examination was completed at a previous date (within 6 months). Inclusion Criteria: * American Society of Anesthesiologist (ASA) Classification I or II * Ages 5 to 14 years * Cooperative behavior at present visit or recorded at the previous encounter (classified as 3 or 4 on the Frankl Behavioral Rating Scale). * At least one erupted caries-free permanent molar in each quadrant * Ability able to speak and understand English or Spanish * There will be no exclusions based on race, gender, and ethnicity.
Exclusion criteria
* ASA Classification III or higher * Uncooperative behavior at present visit or recorded at the previous encounter (classified as 1 or 2 on the Frankl Behavioral Rating Scale). * Patients who require less than four sealants on permanent molars * Patients who do not provide assent or consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Placement Time of Sealants Using Dryshield (DS) vs Cotton Rolls (CRI) | Initial insertion of isolation aid (CRI or DS) and removal of corresponding isolation aid (CRI or DS) | 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. |
| Patient Preference as Assessed by Verbal Self-report Survey | Immediately after the dental procedure is completed, up to 30 minutes | 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. |
Countries
United States
Participant flow
Recruitment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 8 |
| 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.
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. | 8 |
| 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.
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. | 8 |
| Dyshield Isolation (Right) First, Then Cotton Roll Isolation (Left) 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. | 8 |
| Total | 32 |
Baseline characteristics
| Characteristic | Cotton Roll Isolation (Right) First, Then Dryshield Isolation (Left) | Dryshield Isolation (Left) First, Then Cotton Roll Isolation (Right) | Dyshield Isolation (Right) First, Then Cotton Roll Isolation (Left) | Total | Cotton Roll Isolation (Left) First, Then Dryshield Isolation (Right) |
|---|---|---|---|---|---|
| Age, Continuous | 8.6 years | 8.8 years | 8.5 years | 8.6 years | 8.6 years |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants | — |
| Region of Enrollment United States | 8 participants | 8 participants | 8 participants | 32 participants | 8 participants |
| Sex/Gender, Customized Unknown | 8 Participants | 8 Participants | 8 Participants | 32 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
Outcome results
Primary
Patient Preference as Assessed by Verbal Self-report Survey
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.
Time frame: Immediately after the dental procedure is completed, up to 30 minutes
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cotton Roll Isolation (Left) | Patient Preference as Assessed by Verbal Self-report Survey | Cotton Roll Isolation (CRI) | 7 Participants |
| Cotton Roll Isolation (Left) | Patient Preference as Assessed by Verbal Self-report Survey | Dryshield (DS) | 1 Participants |
| Cotton Roll Isolation (Right) | Patient Preference as Assessed by Verbal Self-report Survey | Dryshield (DS) | 4 Participants |
| Cotton Roll Isolation (Right) | Patient Preference as Assessed by Verbal Self-report Survey | Cotton Roll Isolation (CRI) | 4 Participants |
| Dryshield Isolation (Left) | Patient Preference as Assessed by Verbal Self-report Survey | Cotton Roll Isolation (CRI) | 5 Participants |
| Dryshield Isolation (Left) | Patient Preference as Assessed by Verbal Self-report Survey | Dryshield (DS) | 3 Participants |
| Dryshield Isolation (Right) | Patient Preference as Assessed by Verbal Self-report Survey | Cotton Roll Isolation (CRI) | 1 Participants |
| Dryshield Isolation (Right) | Patient Preference as Assessed by Verbal Self-report Survey | Dryshield (DS) | 7 Participants |
Primary
Placement Time of Sealants Using Dryshield (DS) vs Cotton Rolls (CRI)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cotton Roll Isolation (Left) | Placement Time of Sealants Using Dryshield (DS) vs Cotton Rolls (CRI) | 164.88 Seconds | Standard Deviation 28.78 |
| Cotton Roll Isolation (Right) | Placement Time of Sealants Using Dryshield (DS) vs Cotton Rolls (CRI) | 160.50 Seconds | Standard Deviation 26 |
| Dryshield Isolation (Left) | Placement Time of Sealants Using Dryshield (DS) vs Cotton Rolls (CRI) | 164.56 Seconds | Standard Deviation 27.72 |
| Dryshield Isolation (Right) | Placement Time of Sealants Using Dryshield (DS) vs Cotton Rolls (CRI) | 167.81 Seconds | Standard Deviation 28.92 |