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OpenTrials
Completed

NCT Number: NCT01662388

A Clinical Trial of Proximal Composite Restorations

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

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Key information

Conditions

Class II Caries in Premolars

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dental Clinics, Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Separation ring

Device

Separation ring placed along with automatrix band

Other names: BiTine® Separation ring by Palodent, product # 659040)

automatrix band

Device

band placed with a tightening device

Other names: circumferential automatrix band by Dentsply

Primary outcomes

  1. proximal tightness

    Time frame: 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).

Secondary outcomes

  1. proximal contours

    Time frame: 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.

Other outcomes

  1. Overhang of the restoration

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Acronym: Automatrix

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Aug 10, 2012
Registry last updated
Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.