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CompletedNCT05423639Updated Jul 20, 2022

Influence of Lateral Pressure on Sectional Matrix

An interventional study of palodent and optracontact in Class II Dental Caries, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-20.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The aim of this study was evaluating the clinical effectiveness of the hand instrument in conjunction with sectional matrix when applying lateral forces at the contact area during curing to achieve large and tight proximal contacts in posterior teeth.

Read the detailed description

Dental caries is considered as one of the most prevalent oral infections. Initiation of dental caries is a mufti-factorial process, its risk factors includes high loads of cariogenic bacteria, increased frequency of sugar intake, insufficient exposure to fluoride and reduced salivary flow. Other factors that may influence the occurrence of caries include poor oral hygiene and socio-economic status.

Inter-proximal caries lesions develop between the contacting proximal surfaces of two adjacent teeth. Massive evolution took place in restorative techniques, composite resin materials, cavity designs and armamentarium in the past few decades. As well as drastic solutions for earlier problems of composite resins such as bonding to dentin, wear resistance, postoperative sensitivity and polymerization shrinkage. Despite all the progress noted in that area, still achieving proximal contact tightness in Class II resin composite restorations is considered one of the biggest challenges facing clinicians Proximal contact tightness is a physiological dynamic entity of multifactorial origin that is largely affected by tooth type, location, time of day, patient position, mastication and restorative procedures Failure to obtain proper proximal contact area will influence stability of dental arch and transmission of forces along long axis of teeth during mastication. Traumatic masticatory forces can lead to various problems like; rotation and displacement of the teeth, lifting forces on the teeth, deflective occlusal contacts and food impactions that would result in trauma, pain, inflammation and bleeding of the periodontium. The contact must be neither open nor too tight.

Aim of this study was evaluating the clinical effectiveness of the Optra Contact in conjunction with sectional matrix when applying lateral forces at the contact area during curing to achieve large and tight proximal contacts in posterior teeth.

02

Conditions studied

  • Class II Dental Caries

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03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's enrollment of 46 is below the median of 60 across 916 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients having posterior class II carious lesions were included
  • Absence of pain from the tooth to be restored
  • Good general health
  • Age range:18-50 years
  • Fully erupted occluding teeth

Exclusion criteria

Exclusion Criteria:

  • Diastema between posterior teeth
  • Presence of fixed partial dentures
  • Severe periodontal diseases Tooth mobility Non vital teeth
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Control group 1

    Testing Palodent sectional matrix system only when placing Class II resin composite restorations is to increase proximal contact tightness.

    Device: palodent

  • Active comparator
    Intervention group 2

    A pre-contoured instrument called Optra contact (Ivoclar, Vivadent) will be used with group 2. For testing palodent matrix systems with Optracontact when placing Class II resin composite restorations is to increase proximal contact tightness with adjacent teeth when compared with group 1.

    Device: palodent · Device: optracontact

Interventions

  • Devicepalodent

    innovative sectional matrix system with Nickel-Titanium rings, anatomically shaped matrix bands and adaptive self-guiding wedges that provides predictable, tight contacts and restorations that accurately replicate the natural tooth anatomy.

    Also known as: sectional matrix system

  • Deviceoptracontact

    The instrument is used to achieve large and tight proximal contacts in posterior teeth.

    Also known as: Molar Instrument - Ivoclar Vivadent, Bifurcated Tip Instrument

06

What researchers measure

Primary outcomes

  1. Contact tightness Device used: Dental floss Scoring unit US Public Health Service

    Clinical Performance Proximal contact Modified USPHS Ryge criteria

    Time frame: Proximal contact tightness was measured after 6 months

07

Study locations

1 site
  • Cairo University
    Cairo, 19019, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05423639
Lead sponsor
Cairo University
Responsible party
Sara Salem Sayed Ahmed (Principal investigator, Cairo University) — Principal investigator
First posted
Jun 21, 2022
Start date
Jun 1, 2022
Primary completion
Jun 30, 2022
Completion
Jul 1, 2022
Last update
Jul 20, 2022

Study contacts

sara SA sayed, master
principal investigator · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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