Influence of Lateral Pressure on Sectional Matrix

The Influence of Lateral Pressure on Sectional Matrix in Optimizing Proximal Contact Tightness in Class II Resin Composite Restoration

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.

Study Overview

• Status: Completed
• Conditions: Class II Dental Caries
• Intervention / Treatment: Device: palodent; Device: optracontact

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 19019
    • Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.; Other Names: sectional matrix system
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; 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.; Other Names: sectional matrix system; Device: optracontact; The instrument is used to achieve large and tight proximal contacts in posterior teeth.; Other Names: Molar Instrument - Ivoclar Vivadent; Bifurcated Tip Instrument

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: sara SA sayed, master, Cairo university

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 29301030104462

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No