Clinical trial NCT01848496: Clinical Trial of Two Techniques for Gingival Displacement
Official title: A Double-blind Randomized Clinical Trial of Two Techniques for Gingival Displacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Poor Aesthetic of Existing Restoration of Tooth
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Interleukins concentration on gingival crevicular fluid
timeFrame: Before and 1 day after gilgival displacement
Secondary outcomes:
measure: Periodontal indices
timeFrame: Before, 1 day after and 10 day after gingival displacement
Other outcomes:
measure: Self-reported unpleasant flavour and pain
timeFrame: Immediatelly after interventions
Locations:
city: Pelotas
country: Brazil
facility: Pelotas Dental School
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Pelotas
name: Hugo R Sarmento, MSc
role: STUDY_CHAIR
affiliation: Federal University of Pelotas
name: Fernanda Faot, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Pelotas
name: Fábio RM Leite, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.