Impact of Different Separation Methods on Proximal Contact Tightness and Contour of Compound Class ii

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-40
SponsorCairo University

About this trial

The aim of this study is to evaluate the interdental separation of various separation systems and their impact on the proximal contact tightness and contour in compound class II nanohybrid resin composite restorations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals with posterior compound proximal carious cavities in molars.

Age of (25-40) years.

Molars with compound proximal carious cavities score 4 or 5 ICDS.

Vital upper or lower posterior teeth with no signs of irreversible pulpitis.

Disqualifiers

Patients with major systemic disorders or xerostomia.

Patients with periodontal disease.

Patients with para-functional habits.

Presence of malocclusion or signs of pathological teeth wear

Trial design

Design model

Parallel

Treatments tested in this trial

  • I1 (Intervention)

    Device

    Resin ring (DR- Resin ring, Egypt)

  • I2 (Intervention)

    Device

    Elliot separator (Pfingst \& Co, South Plainfield, NJ, USA)

  • I3 (Intervention)

    Device

    Stainless Steel Metal ring (TOR VM ring, Moscow, Russia)

  • C (comparator)

    Device

    Nickel titanium 3D-fusion ring (Garrison, USA)

Treatment groups

160 Participants
are divided into 4 treatment groups
Group A: C (comparator)Active comparator 1 intervention
Group B: I1 (Intervention)Experimental treatment 1 intervention
Group C: I2 (Intervention)Experimental treatment 1 intervention
Group D: I3 (Intervention)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proximal Contact tightness (Success rate)

Visual examination and 25-/50-/100-µm blade according to FDI Criteria

Time frame
From enrollment to the end of treatment at 6 months

Secondary outcomes

1

Form and Contour

Visual examination according to FDI Criteria

Time frame
From enrollment to the end of treatment at 6 months
2

Patient Comfort

Pain rating scale

Time frame
From enrollment to the end of treatment at 6 months
3

Emergence profile

Bitewing Radiographs

Time frame
From enrollment to the end of treatment at 6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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