Clinical Trial of Two Techniques for Gingival Displacement

NCT01848496 | Completed Phase 1

• 1 other identifier: PPGO0015
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Poor Aesthetic of Existing Restoration of Tooth

Outcome Measures

Primary Outcomes (1)

• Interleukins concentration on gingival crevicular fluid

  Before and 1 day after gilgival displacement

Secondary Outcomes (1)

• Periodontal indices

  Before, 1 day after and 10 day after gingival displacement

Other Outcomes (1)

• Self-reported unpleasant flavour and pain

  Immediatelly after interventions

Study Arms (2)

Cordless technique

EXPERIMENTAL

This technique does not employ a gingival cord to obtain gingival displacement.

Procedure: Gingival displacement

Conventional technique

ACTIVE COMPARATOR

This technique employ a gingival cord to obtain gingival displacement.

Procedure: Gingival displacement

Interventions

Gingival displacement PROCEDURE

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.

Conventional technique; Cordless technique

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maximiliano Sergio Cenci: lead

Study Sites (1)

Pelotas Dental School

Pelotas, Rio Grande do Sul, 96015-560, Brazil

Location

Related Publications (3)

• 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.

  PMID: 19040582 BACKGROUND

• 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.

  PMID: 21720749 BACKGROUND

• Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.

  PMID: 1058834 BACKGROUND

Study Officials

• Hugo R Sarmento, MSc

  Federal University of Pelotas

  STUDY CHAIR

• Fernanda Faot, PhD

  Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

• Fábio RM Leite, PhD

  Federal University of Pelotas

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 25, 2013
• First Posted: May 7, 2013
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: May 7, 2013

Record last verified: 2013-05

Locations

BR (1)