Skip to content

A Clinical Trial of Proximal Composite Restorations

A Clinical Trial of Proximal Composite Restorations

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01662388
Acronym
Automatrix
Enrollment
188
Registered
2012-08-10
Start date
2007-11-30
Completion date
2011-12-31
Last updated
2017-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class II Caries in Premolars

Keywords

proximal caries, composite restoration, proximal contact

Brief summary

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

Detailed description

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.

Interventions

DEVICESeparation ring

Separation ring placed along with automatrix band

DEVICEautomatrix band

band placed with a tightening device

Sponsors

Aga Khan University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
proximal tightness1 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

MeasureTime frameDescription
proximal contours1 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

MeasureTime frameDescription
Overhang of the restoration1 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026