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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01848496
Other study ID # PPGO0015
Secondary ID
Status Completed
Phase Phase 1
First received April 25, 2013
Last updated May 3, 2013
Start date January 2012
Est. completion date March 2013

Study information

Verified date May 2013
Source Federal University of Pelotas
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date March 2013
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Poor Aesthetic of Existing Restoration of Tooth

Intervention

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.

Locations

Country Name City State
Brazil Pelotas Dental School Pelotas Rio Grande do Sul

Sponsors (1)

Lead Sponsor Collaborator
Maximiliano Sergio Cenci

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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

Outcome

Type Measure Description Time frame Safety issue
Other 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 Yes
Primary Interleukins concentration on gingival crevicular fluid Before and 1 day after gilgival displacement Yes
Secondary 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 Yes