N/A
N=16
Comparison of Two Gingival Displacement Procedures
Gingival Retraction Techniques
Bottom Line
View on ClinicalTrials.gov: NCT02716727 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Percentage of Errors in Impressions Made for Indirect Restorations — 85.7; 33.3; 28.6; 44.4 percentage of impressions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aquasil Ultra Cordless, Dentsply (Device); Ultrapak, Ultradent cord (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Errors in Impressions Made for Indirect Restorations |
85.7; 33.3; 28.6; 44.4; 71.4; 11.1 | — |
| PRIMARY Mean Time Required to Make the Impression |
5.92; 9.81 | — |
| PRIMARY Mean Patient Discomfort Scores |
7.64; 8.31; 8.64; 7.43; 1.85; 2.12 | — |
| SECONDARY Comparison of Percentage of Impression Errors Made by Residents and Faculty |
— | — |
| SECONDARY Comparison of the Time Required to Make Impressions Between Residents and Faculty |
— | — |
| SECONDARY Mean Patient Discomfort Score Comparison for Procedures Completed by Residents and Faculty |
— | — |
| SECONDARY Comparison of Percentage of Impression Errors Based on Maxillary and Mandibular Arch |
— | — |
| SECONDARY Comparison of the Time Required to Make Impressions in the Maxillary and Mandibular Arch |
— | — |
| SECONDARY Mean Patient Discomfort Score Comparison Based on Maxillary and Mandibular Arch |
— | — |
Summary
Purpose: To compare the quality of impressions made with a cordless gingival displacement procedure versus impressions made with a corded technique. The devices and materials used in both procedures are FDA-approved, marketed, and will be used according to label.
Participants: Approximately sixty (60) adult patients who are treatment planned for indirect restorations (crowns) at the UNC School of Dentistry. Procedures (methods): Participants will be randomized to receive either the cordless gingival displacement procedure (Aquasil Ultra Cordless, Dentsply), or the corded technique (Ultrapak, Intradent) followed by impression with Aquasil Ultra, Dentsply. Participants will complete the Faces pain scale. Impressions will be photographed, digitally scanned, and evaluated.
Eligibility Criteria
Inclusion Criteria
- Patients must be adult males or females over the age of 18.
- Patients must be able and willing to follow study procedures and instructions.
- Patients must have read, understood and signed an informed consent form.
- Patients must be in good general health.
- Patient must require one or more indirect restorations.
- Probing pocket depths around the treatment tooth/teeth must be 4mm or less.
- There must be no bleeding on probing around the treatment tooth/teeth.
- The prepared finish line must be between 0 to 1mm sub-gingival (inclusive).
Exclusion Criteria
- Individuals who have a chronic disease with oral manifestations.
- Individuals who exhibit gross oral pathology.
- Smokers, Diabetics
Data sourced from ClinicalTrials.gov (NCT02716727). 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.