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Clinical Trial of Two Techniques for Gingival Displacement

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ClinicalTrials.gov Identifier: NCT01848496
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : May 7, 2013
Sponsor:
Information provided by (Responsible Party):
Maximiliano Sergio Cenci, Federal University of Pelotas

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.


Condition or disease Intervention/treatment Phase
Poor Aesthetic of Existing Restoration of Tooth Procedure: Gingival displacement Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind Randomized Clinical Trial of Two Techniques for Gingival Displacement
Study Start Date : January 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : March 2013

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.




Primary Outcome Measures :
  1. Interleukins concentration on gingival crevicular fluid [ Time Frame: Before and 1 day after gilgival displacement ]

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


Other Outcome Measures:
  1. Self-reported unpleasant flavour and pain [ Time Frame: Immediatelly after interventions ]
    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.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848496


Locations
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Brazil
Pelotas Dental School
Pelotas, Rio Grande do Sul, Brazil, 96015-560
Sponsors and Collaborators
Maximiliano Sergio Cenci
Investigators
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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