Back to resultsGingival Displacement by Polytetrafluoroethylene & Conventional Retraction Cord
Primary Purpose
Gingival Pocket
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
PTFE Retraction Cord
Sponsored by
About this trial
This is an interventional other trial for Gingival Pocket focused on measuring Polytetrafluoroethylene, Retraction, Soft tissue Management, Retraction cord
Eligibility Criteria
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
Sites / Locations
- Dow University of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional Retraction Cord
PTFE Retraction Cord
Arm Description
Outcomes
Primary Outcome Measures
Difference between Mean Horizontal Gingival Displacement by PTFE retraction cord and Conventional retraction cord among sixty participants as assessed by Stereomicroscope.
Secondary Outcome Measures
Difference between Post-displacement Bleeding by PTFE and conventional retraction cord among sixty participants by visual assessment
Difference between ease of Application of PTFE and conventional retraction cord among sixty participants.
Full Information
NCT ID
NCT04087226
First Posted
September 4, 2019
Last Updated
April 10, 2021
Sponsor
Dow University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04087226
Brief Title
Gingival Displacement by Polytetrafluoroethylene & Conventional Retraction Cord
Official Title
Comparative Evaluation of Gingival Displacement by Polytetrafluoroethylene (PTFE) & Conventional Retraction Cord- A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Pocket
Keywords
Polytetrafluoroethylene, Retraction, Soft tissue Management, Retraction cord
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Retraction Cord
Arm Type
Active Comparator
Arm Title
PTFE Retraction Cord
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
PTFE Retraction Cord
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Difference between Post-displacement Bleeding by PTFE and conventional retraction cord among sixty participants by visual assessment
Time Frame
immediately after cord removal
Title
Difference between ease of Application of PTFE and conventional retraction cord among sixty participants.
Time Frame
immediately after cord removal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Dow University of Health Sciences
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75600
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Gingival Displacement by Polytetrafluoroethylene & Conventional Retraction Cord
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