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Gingival Retraction Techniques clinical trials

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NCT ID: NCT04861285 Completed - Clinical trials for Gingival Retraction Techniques

Gingival Displacement With RACESTYPTINE Solution and RACEGEL: a Prospective, Comparative Randomized Clinical Trial.

RETRACT
Start date: May 10, 2021
Phase: N/A
Study type: Interventional

The study design is a prospective, multi-center randomized, controlled, open label, 3-arm parallel group, post market clinical follow-up (PMCF) Clinical Trial. The aim of the study is to collect clinical performance and safety data from RACEGEL and RACESTYPTINE Solution. Three gingival retraction techniques are being studied: RACESTYPTINE Solution with cord, RACEGEL with cord and RACEGEL without cord. The study will demonstrate the expected performance of these 3 techniques in terms of sulcus opening, i.e. a lateral gingival displacement of at least 200 µm (state of the art) allowing the realization of pre-prosthetic impression with subgingivally margins. 90 subjects (teeth) requiring a dental restoration with subgingival margins for placement of a fixed prosthesis will be enrolled in 3 groups (30 in each group). For each participant, two dental impressions are performed: one impression before the gingival retraction and one impression immediately after the gingival retraction. Both impressions are scanned with 3D dental scanner and images are superimposed before analysis of tissue displacement.

NCT ID: NCT02716727 Completed - Clinical trials for Gingival Retraction Techniques

Comparison of Two Gingival Displacement Procedures

Start date: October 2016
Phase: N/A
Study type: Interventional

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.