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.
Brief Title
DryShield vs Cotton Roll Isolation During Sealants Placement: Efficiency and Patient Preference
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Time
Patient Preference
Eligibility 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.
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.
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Keywords
Sealants
Dryshield
Cotton roll
Isolation
Efficiency
Preference
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
14 Years
Minimum Age
5 Years
NCT Id
NCT02995369
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2016-7229
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
DryShield vs Cotton Roll Isolation During Sealants Placement: Efficiency and Patient
Primary Outcomes
Outcome Description
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 Measure
Placement Time of Sealants Using Dryshield (DS) vs Cotton Rolls (CRI)
Outcome Time Frame
Initial insertion of isolation aid (CRI or DS) and removal of corresponding isolation aid (CRI or DS)
Outcome Description
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.
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 Measure
Patient Preference as Assessed by Verbal Self-report Survey
Outcome Time Frame
Immediately after the dental procedure is completed, up to 30 minutes
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
14
Minimum Age Number (converted to Years and rounded down)
5
Investigators
Investigator Type
Principal Investigator
Investigator Name
Nuntiya Kakanantadilok
Investigator Email
nkakanan@montefiore.org
Investigator Phone
MeSH Terms
PATIENT PREFERENCE
PATIENT SATISFACTION
TREATMENT ADHERENCE AND COMPLIANCE
HEALTH BEHAVIOR
BEHAVIOR