NCT05423639

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

29 days

First QC Date

May 5, 2022

Last Update Submit

July 18, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Clinical Performance Proximal contact Modified USPHS Ryge criteria

    Proximal contact tightness was measured after 6 months

Study Arms (2)

Control group 1

EXPERIMENTAL

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

Device: palodent

Intervention group 2

ACTIVE COMPARATOR

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: palodentDevice: optracontact

Interventions

palodentDEVICE

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
Control group 1Intervention group 2

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

Also known as: Molar Instrument - Ivoclar Vivadent, Bifurcated Tip Instrument
Intervention group 2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 19019, Egypt

Location

Study Officials

  • sara SA sayed, master

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial (RCT).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 5, 2022

First Posted

June 21, 2022

Study Start

June 1, 2022

Primary Completion

June 30, 2022

Study Completion

July 1, 2022

Last Updated

July 20, 2022

Record last verified: 2022-07

Locations