Gingival PocketNCT04087226
Gingival Displacement by Polytetrafluoroethylene & Conventional Retraction Cord
A study testing PTFE Retraction Cord in people with Gingival Pocket, run by Dow University of Health Sciences at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Pocket
- What is being tested?
- PTFE Retraction Cord
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2019to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Indication of subgingival margin location
- Developmental anomaly (anatomical) affecting abutment tooth
- Bleeding disorder
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Gingival Displacement by Polytetrafluoroethylene (PTFE) & Conventional Retraction Cord- A Randomized Control Trial
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.
Read more
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
- Being tested
- PTFE Retraction Cord
- Keywords
- Polytetrafluoroethylene, Retraction, Soft tissue Management, Retraction cord
- Medical subject headings
- Gingival Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTFE Retraction CordDevice
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 group | Role | What they receive |
|---|---|---|
| Conventional Retraction Cord | Active comparator | Not described Receives: Device: PTFE Retraction Cord |
| PTFE Retraction Cord | Experimental | Not described Receives: Device: PTFE Retraction Cord |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between Mean Horizontal Gingival Displacement by PTFE retraction cord and Conventional retraction cord among sixty participants as assessed by Stereomicroscope.
Measured: 3 minutes after displacement
Secondary outcomes (2)
Difference between Post-displacement Bleeding by PTFE and conventional retraction cord among sixty participants by visual assessment
Measured: immediately after cord removal
Difference between ease of Application of PTFE and conventional retraction cord among sixty participants.
Measured: immediately after cord removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start1 Oct 2019
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival PocketStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Humera Nasim, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087226
- Sponsor's protocol ID
- 54321
- Status last verified
- Apr 2021
- First submitted
- 4 Sep 2019
- Last updated
- 14 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Gingival Displacement by Polytetrafluoroethylene (PTFE) & Conventional Retraction Cord- A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04087226
- Acronym / sponsor ID
- 54321
- Conditions
- Gingival Pocket
- Keywords
- Polytetrafluoroethylene, Retraction, Soft tissue Management, Retraction cord
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Retraction Cord | Active comparator | Device: PTFE Retraction Cord |
| PTFE Retraction Cord | Experimental | Device: PTFE Retraction Cord |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Indication of full veneer crown
Key exclusion criteria (4 listed)
- Indication of subgingival margin location
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTFE Retraction CordPolytetrafluoroethylene (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. | Device | Conventional Retraction Cord, PTFE Retraction Cord |
Primary outcome
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
2 secondary outcomes
Difference between Post-displacement Bleeding by PTFE and conventional retraction cord among sixty participants by visual assessment
Time frame: immediately after cord removal
Difference between ease of Application of PTFE and conventional retraction cord among sixty participants.
Time frame: immediately after cord removal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTFE Retraction Cord in people with Gingival Pocket, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.