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Clinical Evaluation of Sectional Matrix Versus Circumferential Matrix for Reproduction of Proximal Contact

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ClinicalTrials.gov Identifier: NCT03795727
Recruitment Status : Not yet recruiting
First Posted : January 8, 2019
Last Update Posted : November 11, 2019
Sponsor:
Information provided by (Responsible Party):
Omar Osama Shaalan, Cairo University

Tracking Information
First Submitted Date  ICMJE January 3, 2019
First Posted Date  ICMJE January 8, 2019
Last Update Posted Date November 11, 2019
Estimated Study Start Date  ICMJE November 11, 2019
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2019)
Proximal contact [ Time Frame: Up to 3 hours from randomization till contact is restored ]
Reproduction of proximal contact either optimum, tight or loose (Categorical)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03795727 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of Sectional Matrix Versus Circumferential Matrix for Reproduction of Proximal Contact
Official Title  ICMJE Clinical Evaluation of Sectional Matrix Versus Circumferential Matrix for Reproduction of Proximal Contact by Undergraduate Students and Postgraduate Dentists: Randomized Controlled Trial
Brief Summary The aim of this study is to evaluate the effects of different matricing techniques either sectional matrix or circumferential matrix on reproduction of optimum proximal contacts and contours during restoration of class II cavities with resin composite by undergraduate students or postgraduate dentists.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Proximal Contact
Intervention  ICMJE
  • Device: MD ring and precontoured sectional matrix by TOR VM
    MD ring (separation ring) and precontoured sectional matrix (thickness 0.035mm hard) and a diamond wedge was used to secure matrix in place
  • Device: Circumferential matrix and tofflemire retainer by Kerr
    Circumferential matrix (thickness 0.038mm) applied by tofflemire retainer and secured in place with diamond wedge
Study Arms  ICMJE
  • Experimental: Sectional matrix
    precontoured sectional matrix band
    Intervention: Device: MD ring and precontoured sectional matrix by TOR VM
  • Active Comparator: Circumferential matrix
    Circumferential matrix band applied by tofflemire retainer
    Intervention: Device: Circumferential matrix and tofflemire retainer by Kerr
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 7, 2019)
48
Original Estimated Enrollment  ICMJE
 (submitted: January 4, 2019)
100
Estimated Study Completion Date  ICMJE January 15, 2020
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Compound class II cavities
  • Good oral hygiene
  • No spacing or crowding
  • Healthy peridontium

Exclusion Criteria:

  • Complex class II cavities
  • Poor oral hygiene
  • Spacing or crowding
  • Evidence of peridontal disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03795727
Other Study ID Numbers  ICMJE circumferential vs sectional
Has Data Monitoring Committee No
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  ICMJE
Plan to Share IPD: No
Responsible Party Omar Osama Shaalan, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP