Gingival Displacement by Polytetrafluoroethylene & Conventional Retraction Cord

NCT04087226 | Completed

• 1 other identifier: 54321
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Pocket

Keywords

Polytetrafluoroethylene; Retraction; Soft tissue Management; Retraction cord

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Conventional Retraction Cord

ACTIVE COMPARATOR

Device: PTFE Retraction Cord

PTFE Retraction Cord

EXPERIMENTAL

Device: PTFE Retraction Cord

Interventions

PTFE Retraction Cord DEVICE

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.

Conventional Retraction Cord; PTFE Retraction Cord

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, 75600, Pakistan

Location

MeSH Terms

Conditions

Gingival Pocket

Condition Hierarchy (Ancestors)

Gingivitis; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 12, 2019
• Study Start: October 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: April 14, 2021

Record last verified: 2021-04

Locations

PA (1)