Gingival Displacement by Polytetrafluoroethylene & Conventional Retraction Cord

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04087226

Enrollment

Registered

2019-09-12

Start date

2019-10-01

Completion date

2020-09-30

Last updated

2021-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Pocket

Keywords

Polytetrafluoroethylene, Retraction, Soft tissue Management, Retraction cord

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.

Interventions

DEVICEPTFE 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026