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Influence of Lateral Pressure on Sectional Matrix

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05423639
Recruitment Status : Completed
First Posted : June 21, 2022
Last Update Posted : July 20, 2022
Sponsor:
Information provided by (Responsible Party):
Sara Salem Sayed Ahmed, Cairo University

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.

Condition or disease Intervention/treatment Phase
Class II Dental Caries Device: palodent Device: optracontact Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial (RCT).
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Influence of Lateral Pressure on Sectional Matrix in Optimizing Proximal Contact Tightness in Class II Resin Composite Restoration
Actual Study Start Date : June 1, 2022
Actual Primary Completion Date : June 30, 2022
Actual Study Completion Date : July 1, 2022

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 Name: 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 Name: 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




Primary Outcome Measures :
  1. Contact tightness Device used: Dental floss Scoring unit US Public Health Service [ Time Frame: Proximal contact tightness was measured after 6 months ]
    Clinical Performance Proximal contact Modified USPHS Ryge criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05423639


Locations
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Egypt
Cairo University
Cairo, Egypt, 19019
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: sara SA sayed, master Cairo University
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Responsible Party: Sara Salem Sayed Ahmed, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT05423639    
Other Study ID Numbers: 29301030104462
First Posted: June 21, 2022    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases