Clinical Trial of Two Techniques for Gingival Displacement

NCT ID: NCT01848496

Last Updated: 2013-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-03-31

Brief Summary

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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

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

Conditions

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Poor Aesthetic of Existing Restoration of Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Cordless technique

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

Group Type EXPERIMENTAL

Gingival displacement

Intervention Type 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

This technique employ a gingival cord to obtain gingival displacement.

Group Type ACTIVE_COMPARATOR

Gingival displacement

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maximiliano Sergio Cenci

OTHER

Sponsor Role lead

Responsible Party

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Maximiliano Sergio Cenci

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hugo R Sarmento, MSc

Role: STUDY_CHAIR

Federal University of Pelotas

Fernanda Faot, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Pelotas

Fábio RM Leite, PhD

Role: STUDY_DIRECTOR

Federal University of Pelotas

Locations

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Pelotas Dental School

Pelotas, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 19040582 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21720749 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 1058834 (View on PubMed)

Other Identifiers

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PPGO0015

Identifier Type: -

Identifier Source: org_study_id

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