A Clinical Trial of Proximal Composite Restorations (Automatrix)
19. april 2017 opdateret af: Farhan Raza Khan, Aga Khan University
Several techniques have been advocated to get good contacts in dental composite restorations including interdental separation ring.
The investigators study focuses on using separation ring with circumferential matrix band instead of a sectional band.
Moreover, the investigators have attempted to study proximal tightness and proximal contours of composite restoration as separate variables
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
A total of 188 premolar teeth with proximal cavity to be assigned on alternate basis in two groups. Intervention group teeth received Automatrix band after cavity preparation followed by the separation ring using clamp while the control group received Automatrix band alone.
All teeth to be restored with P-60 composite restorative material(3M-ESPE Dental, USA). Outcome (proximal tightness) is determined by a blinded assessor just after the restoration.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
188
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Sindh
-
Karachi, Sindh, Pakistan, 74800
- Dental Clinics, Aga Khan University Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- patients who had supra gingival Class II cavities in permanent premolars. Teeth with cavity isthmus less than one-third of intercuspal distance were inducted
Exclusion Criteria:
- Partially erupted teeth, teeth with non-carious tooth surface wear or with orthodontic bands or brackets or whose adjacent tooth continuous with the cavity side is missing were excluded.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: automatrix band, Separation ring
The prepared teeth received Automatrix band (similar to the control group, product code# 62422513).
The Automatrix was burnished against the adjacent tooth gently.
Anatomical wedges were applied in the proximal area and then the separation ring (BiTine® round ring by Palodent systems, Dentsply International, DE, USA product # 659040) placed with the help of retainer forceps.
|
Separation ring placed along with automatrix band
Andre navne:
band placed with a tightening device
Andre navne:
|
|
Aktiv komparator: automatrix band
Teeth received Automatrix band alone (Wide-Regular type, dimensions 7.9 mm height and 0.05mm thickness, product code # 62422513).
It was secured on the prepared tooth and burnished against the adjacent tooth gently.
Anatomical wedges were placed in the inter-proximal area gingival to the cavity preparation.
|
band placed with a tightening device
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
proximal tightness
Tidsramme: 1 day (just after dental restoration)
|
The tightness of the proximal contact area resulting from either of the two matrix band system.
It was measured using a nine inch long nylon dental floss (Johnson and Johnson, USA).
|
1 day (just after dental restoration)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
proximal contours
Tidsramme: 1 day (just after restoration placement)
|
To be examined clinically with an explorer and mouth mirror and then on the periapical radiograph by the blinded co investigator.
|
1 day (just after restoration placement)
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overhang of the restoration
Tidsramme: 1 day (just after the restoration placement)
|
To be examined clinically with an explorer and mouth mirror and then on the periapical radiograph by the blinded co investigator.
|
1 day (just after the restoration placement)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Farhan R Khan, FCPS, AKU
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2007
Primær færdiggørelse (Faktiske)
1. november 2011
Studieafslutning (Faktiske)
1. december 2011
Datoer for studieregistrering
Først indsendt
8. august 2012
Først indsendt, der opfyldte QC-kriterier
9. august 2012
Først opslået (Skøn)
10. august 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. april 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. april 2017
Sidst verificeret
1. april 2017
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 640-Sur-ERC-06
- 640-Sur/ERC-06 (Anden identifikator: Aga khan University)
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