Clinical Trial of Two Techniques for Gingival Displacement

A Double-blind Randomized Clinical Trial of Two Techniques for Gingival Displacement

Regardless of the selected technique for dental impression, gingival displacement is an essential procedure specially when making impressions of subgingival finishing lines, because a moisture-free sulcus is a requirement for an effective impression.

The objective of this randomized clinical study is to evaluate the efficacy of the conventional and cordless gingival displacement (GD) techniques.

Study Overview

• Status: Completed
• Conditions: Poor Aesthetic of Existing Restoration of Tooth
• Intervention / Treatment: Procedure: Gingival displacement

Detailed Description

On conventional technique we normally use a cord for gingival displacement. On the other hand, on cordless technique do not require this need.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Pelotas, Rio Grande do Sul, Brazil, 96015-560
      • Pelotas Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• good general and dental health
• at least two anterior teeth with an indication of prosthetic dental crown

Exclusion Criteria:

• smoking habits
• systemic diseases
• pregnant
• had not consumed antibiotics or anti-inflammatory drugs in the last 60 days
• the selected teeth must have good periodontal health characterized by regular gingival margin with at least 2 mm of attached gingiva, non-fibrotic gingival tissue, no marginal recession, probing depth ≤ 3 mm, no evidence of significant loss of bone insertion and present no visible plaque and gingival bleeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cordless technique; This technique does not employ a gingival cord to obtain gingival displacement.	Procedure: Gingival displacement; Gingival displacement is a dental procedure that allows exposure of the finishing line of a dental cavity in order to produce a well-adapted restoration.
Active Comparator: Conventional technique; This technique employ a gingival cord to obtain gingival displacement.	Procedure: Gingival displacement; Gingival displacement is a dental procedure that allows exposure of the finishing line of a dental cavity in order to produce a well-adapted restoration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Interleukins concentration on gingival crevicular fluid	Before and 1 day after gilgival displacement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periodontal indices	Periodontal indices (attachment level, gingival bleeding and plaque index) were evaluated before and after gingival displacement by the both techniques.	Before, 1 day after and 10 day after gingival displacement

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported unpleasant flavour and pain	Also were evaluated subjective parameters (unpleasant flavor and pain) self-reported by the volunteers during gingival displacement. These subjective outcomes were collected using the visual analogic scale.	Immediatelly after interventions

Collaborators and Investigators

• Sponsor: Maximiliano Sergio Cenci
• Investigators: Study Chair: Hugo R Sarmento, MSc, Federal University of Pelotas; Principal Investigator: Fernanda Faot, PhD, Federal University of Pelotas; Study Director: Fábio RM Leite, PhD, Federal University of Pelotas

Publications and helpful links

General Publications

• Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
• Al Hamad KQ, Azar WZ, Alwaeli HA, Said KN. A clinical study on the effects of cordless and conventional retraction techniques on the gingival and periodontal health. J Clin Periodontol. 2008 Dec;35(12):1053-8. doi: 10.1111/j.1600-051X.2008.01335.x.
• Passariello C, Puttini M, Virga A, Gigola P. Microbiological and host factors are involved in promoting the periodontal failure of metaloceramic crowns. Clin Oral Investig. 2012 Jun;16(3):987-95. doi: 10.1007/s00784-011-0585-0. Epub 2011 Jul 1.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: April 25, 2013
• First Submitted That Met QC Criteria: May 3, 2013
• First Posted (Estimate): May 7, 2013

Study Record Updates

• Last Update Posted (Estimate): May 7, 2013
• Last Update Submitted That Met QC Criteria: May 3, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: PPGO0015