Influence of Lateral Pressure on Sectional Matrix

• ClinicalTrials.gov Identifier: NCT05423639
• Recruitment Status: Completed
• First Posted: June 21, 2022
• Last Update Posted: July 20, 2022
• Sponsor: Cairo University
• Information provided by (Responsible Party): Sara Salem Sayed Ahmed, Cairo University

Tracking Information

• First Submitted Date: May 5, 2022
• First Posted Date: June 21, 2022
• Last Update Posted Date: July 20, 2022
• Actual Study Start Date: June 1, 2022
• Actual Primary Completion Date: June 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 15, 2022)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized Controlled Trial (RCT).

Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment

• Condition: Class II Dental Caries

Intervention

• 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

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.
  Intervention: 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.
  Interventions:

  • Device: palodent
  • Device: optracontact

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 15, 2022): 46
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 1, 2022
• Actual Primary Completion Date: June 30, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT05423639
• Other Study ID Numbers: 29301030104462
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sara Salem Sayed Ahmed, Cairo University
• Original Responsible Party: Same as current
• Current Study Sponsor: Cairo University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: sara SA sayed, master; Cairo University

• PRS Account: Cairo University
• Verification Date: July 2022