Gingival Displacement by Polytetrafluoroethylene & Conventional Retraction Cord

Gingival Pocket Clinical Trial

Official title:

Comparative Evaluation of Gingival Displacement by Polytetrafluoroethylene (PTFE) & Conventional Retraction Cord- A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04087226
• Other study ID #: 54321
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: April 2021
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Pocket

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Dow University of Health Sciences	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference between Post-displacement Bleeding by PTFE and conventional retraction cord among sixty participants by visual assessment		immediately after cord removal
Secondary	Difference between ease of Application of PTFE and conventional retraction cord among sixty participants.		immediately after cord removal