Gingival Displacement by Polytetrafluoroethylene & Conventional Retraction Cord

Overview

To achieve harmony between restoration and surrounding periodontium, soft tissue management plays a pivotal role. Various Gingival displacement techniques show varying results in achieving the goals of displacement. The most preferred method of displacement by dental practitioners is through conventional retraction cord made up of cotton, which besides its advantages, poses certain drawbacks, including low tear strength, high friction, and fiber remnants within the sulcus. Polytetrafluoroethylene (PTFE) retraction cord, is a fluoropolymer, known for its high tear strength, low friction, and bio-compatibility. This study aims to determine the difference of horizontal gingival displacement between PTFE and conventional retraction cord. Participants inducted in this study will be assessed for eligibility. qualifying subjects will receive crown preparation for Porcelain-fused to-metal crown. subjects will then be randomly allocated to either of the two arms of intervention. After making a pre-displacement impression, Retraction cord will be applied for 3 minutes, then removed to record post-displacement impression. the difference in pre and post-displacement mean gingival sulcus width will be assessed by a stereomicroscope using image analysis software.

Full Title of Study: “Comparative Evaluation of Gingival Displacement by Polytetrafluoroethylene (PTFE) & Conventional Retraction Cord- A Randomized Control Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: September 30, 2020

Interventions

  • Device: PTFE Retraction Cord
    • Polytetrafluoroethylene (PTFE) Retraction cord will be gently applied in gingival sulcus with minimal pressure. The intervention will be applied for three minutes in gingival sulcus, followed by a two stage addition silicone impression.

Arms, Groups and Cohorts

  • Active Comparator: Conventional Retraction Cord
  • Experimental: PTFE Retraction Cord

Clinical Trial Outcome Measures

Primary Measures

  • Difference between Mean Horizontal Gingival Displacement by PTFE retraction cord and Conventional retraction cord among sixty participants as assessed by Stereomicroscope.
    • Time Frame: 3 minutes after displacement

Secondary Measures

  • Difference between Post-displacement Bleeding by PTFE and conventional retraction cord among sixty participants by visual assessment
    • Time Frame: immediately after cord removal
  • Difference between ease of Application of PTFE and conventional retraction cord among sixty participants.
    • Time Frame: immediately after cord removal

Participating in This Clinical Trial

Inclusion Criteria

  • Indication of full veneer crown – Age group: 18-60 years – Probing Depth 2-3mm and no bleeding on probing – No signs of gingival/periodontal disease Exclusion Criteria:

  • Indication of subgingival margin location – Developmental anomaly (anatomical) affecting abutment tooth – Bleeding disorder – Pregnancy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Dow University of Health Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Humera Nasim, Principal Investigator – Dow University of Health Sciences

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