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A Clinical Trial of Composite Class II Restorations With Two Different Matrix Bands

Comparison of Saddle Contoured Metal Matrix and Pre-contoured Self-adhesive Matrix in Composite Resin Class II Restorations

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05414656
Enrollment
60
Registered
2022-06-10
Start date
2022-05-02
Completion date
2022-10-31
Last updated
2022-06-10

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

Conditions

Class II Caries in Posterior Teeth

Brief summary

Various procedures and techniques have been devised in an attempt to generate tighter and more anatomic proximal contacts with class II composite restorations. The investigators study focuses on using Saddle contoured metal matrix and pre-contoured self-adhesive matrix .Moreover, the investigators have attempted to study proximal tightness and proximal contours of composite restoration as separate variables.

Detailed description

A total of 60 posterior teeth with proximal cavity to be assigned on alternate basis in two equal groups. Group A teeth received the Saddle contoured metal matrix and group B pre-contoured self-adhesive matrix after cavity preparation. All teeth to be restored with Nano hybrid composite restorative material. Outcome of proximal contours and contact tightness is determined by a blinded assessor just after the restoration.

Interventions

DEVICESaddle contoured metal matrix, Pre-contoured self-adhesive matrix

Saddle contoured metal matrix placed with the small clipper. The -contoured self-adhesive matrix has self adhesive ability.

Sponsors

Pakistan Institute of Medical Sciences
Lead SponsorOTHER_GOV

Study design

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* • Permanent fully erupted teeth with class II supra-gingival caries or the necessity of replacing class II restoration. * The patient who has adjacent teeth available for the contact with surrounding tooth structure. * Teeth with cavity isthmus less than one-third of inter-cuspal distance

Exclusion criteria

* • Partially erupted or deciduous teeth. * Teeth with orthodontic bands or brackets. * 3rd Molar and rotated teeth. * Teeth with dental caries extending up to pulp with periapical pathosis or periodontally weak teeth.

Design outcomes

Primary

MeasureTime frameDescription
proximal contacts tightnessimmediately after procedureThe tightness of the proximal contact area resulting from Saddle contoured metal matrix and pre-contoured self-adhesive matrix . It was measured using a nine inch long nylon dental floss (Oral-B, USA).

Secondary

MeasureTime frameDescription
Proximal contours and overhangsimmediately after procedureTo be examined clinically with an explorer and mouth mirror and then on the radiograph by the blinded co investigator.

Countries

Pakistan

Contacts

Primary ContactNosheen Sarwar, BDS
nosheensarwar48@gmail.com+923088895652

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026