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Influence of Lateral Pressure on Sectional Matrix

Primary Purpose

Class II Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
palodent
optracontact
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Dental Caries

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Control group 1

Intervention group 2

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Contact tightness Device used: Dental floss Scoring unit US Public Health Service
Clinical Performance Proximal contact Modified USPHS Ryge criteria

Secondary Outcome Measures

Full Information

First Posted
May 5, 2022
Last Updated
July 18, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05423639
Brief Title
Influence of Lateral Pressure on Sectional Matrix
Official Title
The Influence of Lateral Pressure on Sectional Matrix in Optimizing Proximal Contact Tightness in Class II Resin Composite Restoration
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Dental Caries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial (RCT).
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group 1
Arm Type
Experimental
Arm Description
Testing Palodent sectional matrix system only when placing Class II resin composite restorations is to increase proximal contact tightness.
Arm Title
Intervention group 2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
palodent
Other Intervention Name(s)
sectional matrix system
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
optracontact
Other Intervention Name(s)
Molar Instrument - Ivoclar Vivadent, Bifurcated Tip Instrument
Intervention Description
The instrument is used to achieve large and tight proximal contacts in posterior teeth.
Primary Outcome Measure Information:
Title
Contact tightness Device used: Dental floss Scoring unit US Public Health Service
Description
Clinical Performance Proximal contact Modified USPHS Ryge criteria
Time Frame
Proximal contact tightness was measured after 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sara SA sayed, master
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
19019
Country
Egypt

12. IPD Sharing Statement

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Influence of Lateral Pressure on Sectional Matrix

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