Comparison of Two Gingival Displacement Procedures

Completed · Not applicable

Conditions studied: Gingival Retraction Techniques

In brief

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.

Key facts

Study ID

NCT02716727

Run by

University of North Carolina, Chapel Hill

People needed

16

Starts

2016-10-01

Expected to finish

2019-11-01

Last updated by the study team

2020-08-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• Individuals who have a chronic disease with oral manifestations.
• Individuals who exhibit gross oral pathology.
• Smokers, Diabetics

Where it is running

• UNC School of Dentistry — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.