Objectives: Quantitative assessment of gingival sulcus width (lateral displacement) obtained by three retraction systems (Racestyptine +Cord, Racegel + Cord and Racegel) in order to collect clinical performance and safety data from them (Retract study).
Methods: Design of the trial was prospective, multi-center randomized, controlled, open label, 3-arm parallel group. The primary endpoint was the lateral gingival displacement.
In this post-market clinical follow up study, both Racestyptine Solution and Racegel are investigational devices. No device was used as comparator, each gingival retraction system was compared to a reference value of minimal expected tissue displacement.
Results: The lateral gingival displacement obtained by Racestyptine with a retraction cord (253 ± 59 µm, p<0.0001) and by Racegel with a retraction cord (247 ± 61 µm, p=0.0007) were significantly higher than 200 µm. Lateral displacement obtained with Racegel cordless was 207 ± 57 µm (p=0.53). Astringent effect of the three retractions systems was confirmed by the absence of crevicular fluid reported on more than 96% of the patients and by bleeding observed on 7 cases. No peri-odondal damage was observed immediately and 7 days after retraction. Prosthesis fits correctly on the prepared tooth for all patients of the 3 groups.
Conclusions: RETRACT Study shows that Racestyptine and Racegel provides a sufficient sulcus opening prior impression taking in restorative dentistry.
Authors: (FIRST NAME, LAST NAME): HUGUES COLOMBEL1, MARIE-JOSEPH DAUTEL1, FRANCOISE BASLE1, JACQUES RUBIN1, DOMINIQUE BASLE1, HUGO ABGRALL1, FRANCK DELANOUE1, VINCENT BAR1, MARIE THEVENIAU2, ANNE DAUTEL3
INSTITUTIONS (ALL): 1. Dentistry, Private, RENNES, BRETAGNE, France.
2. Centre de Soins Dentaires du CHU de Rennes Faculté d’Odontologie, CHU Rennes Université de Rennes 1, RENNES, BRETAGNE, France.
3. Centre de Soins Dentaires du CHU de Rennes Faculté d’Odontologie – Université de Rennes 1, CHU RENNES, RENNES, BRETAGNE, France.