N/A
N=32
DryShield vs Cotton Roll Isolation During Sealants Placement: Efficiency and Patient Preference
Time · Patient Preference
Bottom Line
View on ClinicalTrials.gov: NCT02995369 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Placement Time of Sealants Using Dryshield (DS) vs Cotton Rolls (CRI) — 164.88; 160.50; 164.56; 167.81 Seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DryShield (Device); Cotton rolls (Other)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Placement Time of Sealants Using Dryshield (DS) vs Cotton Rolls (CRI) |
164.88; 160.50; 164.56; 167.81 | — |
| PRIMARY Patient Preference as Assessed by Verbal Self-report Survey |
7; 4; 5; 1; 1; 4 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02995369). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.