Data Accuracy, Bleeding ControlNCT07119281
Gingival Retraction for Digital Scan Data
A study testing Group A: Cordless paste with astringent (EXP): Expasyl (Acteon PVT LTD), Group B: Cordless paste without astringent (MF): Magic FoamCord (Coltene Whaledent AG) and Group C: Laser troughing (LT): Diode laser (iLase; Biolase Inc.) in people with Data Accuracy, Bleeding Control, run by Istanbul University at 3 sites in United States.
Trial summary
The study aims to identify which retraction method offers optimal balance between tissue displacement, scan clarity, and patient comfort, particularly in the esthetic zone, while avoiding the use of CBCT. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Data Accuracy, Bleeding Control
- What is being tested?
- Group A: Cordless paste with astringent (EXP): Expasyl (Acteon PVT LTD), Group B: Cordless paste without astringent (MF): Magic FoamCord (Coltene Whaledent AG) and Group C: Laser troughing (LT): Diode laser (iLase; Biolase Inc.)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 2024to 4 May 2025
- 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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 25-40 years
- Maxillary premolars with normal anatomical size, contour, and position
- Systemically healthy individuals
- Healthy gingiva and periodontium around abutments (GI = 0)
- Good oral hygiene (PI = 0)
- Pocket depth ≤ 3 mm
- Thick gingival biotype
Who cannot join
- Smokers
- Systemic conditions affecting periodontal status
- Attachment loss, bleeding on probing, or plaque accumulation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Medial University of South Carolina
Charleston, South Carolina, 29425
Medical University of South Carolina, College of Dental Medicine
Charleston, South Carolina, 29425
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Effect of Retraction Techniques on Scan Accuracy
The study aims to identify which retraction method offers optimal balance between tissue displacement, scan clarity, and patient comfort, particularly in the esthetic zone, while avoiding the use of CBCT. Results will guide clinicians in selecting the most effective and minimally invasive approach for digital impression workflows.
Read the detailed description
This prospective clinical study investigates the impact of various gingival retraction techniques on scan accuracy, gingival displacement, bleeding control, and finish line visibility during intraoral scanning of anterior teeth. A total of 32 systemically and periodontally healthy participants were randomly assigned to one of five groups, each using a different retraction method:
- Retraction cord with astringent (RCA; Control group): Knitted cord impregnated with aluminum chloride (Ultrapak + Viscostat Clear; Ultradent Inc.)
- Cordless paste with astringent (EXP): Expasyl (Acteon PVT LTD)
- Cordless paste without astringent (MF): Magic FoamCord (Coltene Whaledent AG)
- Laser troughing (LT): Diode laser (iLase; Biolase Inc.)
Digital impressions were obtained before and after retraction using a Trios 3Shape intraoral scanner. The gingival displacement was measured digitally, and scan accuracy was analyzed via RMS error. Bleeding index, finish line visibility, and patient discomfort (VAS) were also recorded.
- Conditions
- Data Accuracy, Bleeding Control
- Being tested
- Group A: Cordless paste with astringent (EXP): Expasyl (Acteon PVT LTD), Group B: Cordless paste without astringent (MF): Magic FoamCord (Coltene Whaledent AG), Group C: Laser troughing (LT): Diode laser (iLase; Biolase Inc.), Group D: Retraction cord with astringent (RCA; Control group): Knitted cord impregnated with aluminum chloride (Ultrapak + Viscostat Clear; Ultradent Inc.)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A: Cordless paste with astringent (EXP): Expasyl (Acteon PVT LTD)Procedure or surgery
Chemical gingival retraction method
Group B: Cordless paste without astringent (MF): Magic FoamCord (Coltene Whaledent AG)Procedure or surgery
Chemical gingival retraction method
Group C: Laser troughing (LT): Diode laser (iLase; Biolase Inc.)Procedure or surgery
Gingival retraction will be performed by using only laser. Cord will not be used.
Group D: Retraction cord with astringent (RCA; Control group): Knitted cord impregnated with aluminum chloride (Ultrapak + Viscostat Clear; Ultradent Inc.)Procedure or surgery
Mechanical and chemical gingival retraction method will be used.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Cordless paste with astringent (EXP) | Experimental | gingival retraction model 1 Expasyl (Acteon PVT LTD) Receives: Procedure: Group A: Cordless paste with astringent (EXP): Expasyl (Acteon PVT LTD) |
| Group B: Cordless paste without astringent (MF): | Experimental | gingival retraction model 2 Magic FoamCord (Coltene Whaledent AG) Receives: Procedure: Group B: Cordless paste without astringent (MF): Magic FoamCord (Coltene Whaledent AG) |
| Group C:Laser troughing (LT): | Experimental | gingival retraction model 3 Diode laser (iLase; Biolase Inc.) Receives: Procedure: Group C: Laser troughing (LT): Diode laser (iLase; Biolase Inc.) |
| Retraction cord with astringent (RCA; Control group): | Other | control-Knitted cord impregnated with aluminum chloride (Ultrapak + Viscostat Clear; Ultradent Inc.) Receives: Procedure: Group D: Retraction cord with astringent (RCA; Control group): Knitted cord impregnated with aluminum chloride (Ultrapak + Viscostat Clear; Ultradent Inc.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
gingival displacement
Vertical and horizontal gingival displacement before and after gingival retraction method will be measured by using digital caliper.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Feb 2024
- Primary completion4 May 2025
- Study completion4 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Data Accuracy, Bleeding ControlStudies 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Merve Benli, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119281
- Sponsor's protocol ID
- mbenli
- Other IDs
- mbenli
- Status last verified
- Aug 2025
- First submitted
- 21 Jul 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: patient's data obtained from study
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Retraction Techniques on Scan Accuracy
- ClinicalTrials.gov ID
- NCT07119281
- Acronym / sponsor ID
- mbenli
- Conditions
- Data Accuracy, Bleeding Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 4 May 2025 (actual)
- Study completion
- 4 May 2025 (actual)
- First posted
- 13 Aug 2025 (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.
The study aims to identify which retraction method offers optimal balance between tissue displacement, scan clarity, and patient comfort, particularly in the esthetic zone, while avoiding the use of CBCT. Results will guide clinicians in selecting the most effective and minimally invasive approach for digital impression workflows.
Detailed description
This prospective clinical study investigates the impact of various gingival retraction techniques on scan accuracy, gingival displacement, bleeding control, and finish line visibility during intraoral scanning of anterior teeth. A total of 32 systemically and periodontally healthy participants were randomly assigned to one of five groups, each using a different retraction method:
- Retraction cord with astringent (RCA; Control group): Knitted cord impregnated with aluminum chloride (Ultrapak + Viscostat Clear; Ultradent Inc.)
- Cordless paste with astringent (EXP): Expasyl (Acteon PVT LTD)
- Cordless paste without astringent (MF): Magic FoamCord (Coltene Whaledent AG)
- Laser troughing (LT): Diode laser (iLase; Biolase Inc.)
Digital impressions were obtained before and after retraction using a Trios 3Shape intraoral scanner. The gingival displacement was measured digitally, and scan accuracy was analyzed via RMS error. Bleeding index, finish line visibility, and patient discomfort (VAS) were also recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: Cordless paste with astringent (EXP) | Experimental | Procedure: Group A: Cordless paste with astringent (EXP): Expasyl (Acteon PVT LTD)gingival retraction model 1 Expasyl (Acteon PVT LTD) |
| Group B: Cordless paste without astringent (MF): | Experimental | Procedure: Group B: Cordless paste without astringent (MF): Magic FoamCord (Coltene Whaledent AG)gingival retraction model 2 Magic FoamCord (Coltene Whaledent AG) |
| Group C:Laser troughing (LT): | Experimental | Procedure: Group C: Laser troughing (LT): Diode laser (iLase; Biolase Inc.)gingival retraction model 3 Diode laser (iLase; Biolase Inc.) |
| Retraction cord with astringent (RCA; Control group): | Other | Procedure: Group D: Retraction cord with astringent (RCA; Control group): Knitted cord impregnated with aluminum chloride (Ultrapak + Viscostat Clear; Ultradent Inc.)control-Knitted cord impregnated with aluminum chloride (Ultrapak + Viscostat Clear; Ultradent Inc.) |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 25-40 years
- Maxillary premolars with normal anatomical size, contour, and position
- Systemically healthy individuals
- Healthy gingiva and periodontium around abutments (GI = 0)
- Good oral hygiene (PI = 0)
Key exclusion criteria (3 listed)
- Smokers
- Systemic conditions affecting periodontal status
- Attachment loss, bleeding on probing, or plaque accumulation
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 |
|---|---|---|
| Group A: Cordless paste with astringent (EXP): Expasyl (Acteon PVT LTD)Chemical gingival retraction method | Procedure or surgery | Group A: Cordless paste with astringent (EXP) |
| Group B: Cordless paste without astringent (MF): Magic FoamCord (Coltene Whaledent AG)Chemical gingival retraction method | Procedure or surgery | Group B: Cordless paste without astringent (MF): |
| Group C: Laser troughing (LT): Diode laser (iLase; Biolase Inc.)Gingival retraction will be performed by using only laser. Cord will not be used. | Procedure or surgery | Group C:Laser troughing (LT): |
| Group D: Retraction cord with astringent (RCA; Control group): Knitted cord impregnated with aluminum chloride (Ultrapak + Viscostat Clear; Ultradent Inc.)Mechanical and chemical gingival retraction method will be used. | Procedure or surgery | Retraction cord with astringent (RCA; Control group): |
Primary outcome
gingival displacement
Time frame: 30 days
Vertical and horizontal gingival displacement before and after gingival retraction method will be measured by using digital caliper.
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 8 Sep 2025.
- Individual participant dataSharing planned: Yes. patient's data obtained from study
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A: Cordless paste with astringent (EXP): Expasyl (Acteon PVT LTD), Group B: Cordless paste without astringent (MF): Magic FoamCord (Coltene Whaledent AG) and Group C: Laser troughing (LT): Diode laser (iLase; Biolase Inc.) in people with Data Accuracy, Bleeding Control, run by Istanbul University at 3 sites in United States.
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 7 inclusion and 3 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 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
gingival displacement (time frame: 30 days). 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 8 Sep 2025.