- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01848496
Clinical Trial of Two Techniques for Gingival Displacement
A Double-blind Randomized Clinical Trial of Two Techniques for Gingival Displacement
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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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-
Rio Grande do Sul
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Pelotas, Rio Grande do Sul, Brasilien, 96015-560
- Pelotas Dental School
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Cordless technique
This technique does not employ a gingival cord to obtain 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.
|
|
Aktiv komparator: Conventional technique
This technique employ a gingival cord to obtain 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Interleukins concentration on gingival crevicular fluid
Tidsramme: Before and 1 day after gilgival displacement
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Before and 1 day after gilgival displacement
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Periodontal indices
Tidsramme: Before, 1 day after and 10 day after gingival displacement
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Periodontal indices (attachment level, gingival bleeding and plaque index) were evaluated before and after gingival displacement by the both techniques.
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Before, 1 day after and 10 day after gingival displacement
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-reported unpleasant flavour and pain
Tidsramme: 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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Immediatelly after interventions
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Hugo R Sarmento, MSc, Federal University of Pelotas
- Ledende efterforsker: Fernanda Faot, PhD, Federal University of Pelotas
- Studieleder: Fábio RM Leite, PhD, Federal University of Pelotas
Publikationer og nyttige links
Generelle publikationer
- Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- PPGO0015
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