Gingival Displacement by Polytetrafluoroethylene & Conventional Retraction Cord

Not Applicable

Completed

• Conditions: Gingival Pocket
• Interventions: Device: PTFE Retraction Cord

• Registration Number: NCT04087226
• Lead Sponsor: Dow University of Health Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-11
• Study First Posted: 2019-09-12
• Study Start: 2019-10-01
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-10
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Retraction Cord	PTFE Retraction Cord	-
PTFE Retraction Cord	PTFE Retraction Cord	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dow University of Health Sciences; 🇵🇰 Karachi, Sindh, Pakistan