CClinicalTrials.gg
CompletedNCT07119281Updated Sep 8, 2025

Gingival Retraction for Digital Scan Data

An interventional study of Group A: Cordless paste with astringent (EXP): Expasyl (Acteon PVT LTD) and Group B: Cordless paste without astringent (MF): Magic FoamCord (Coltene Whaledent AG) in Data Accuracy, Bleeding Control, sponsored by Istanbul University. Completed at 3 sites in United States. Open to participants aged 25 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by Istanbul University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Feb 2024, registered Jul 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
25 Years to 40 Years
Sex
All
01

Study 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. 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:

  1. Retraction cord with astringent (RCA; Control group): Knitted cord impregnated with aluminum chloride (Ultrapak + Viscostat Clear; Ultradent Inc.)
  2. Cordless paste with astringent (EXP): Expasyl (Acteon PVT LTD)
  3. Cordless paste without astringent (MF): Magic FoamCord (Coltene Whaledent AG)
  4. 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.

02

Conditions studied

  • Data Accuracy, Bleeding Control
03

In context

Lead sponsor

Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age 25-40 years
  2. Maxillary premolars with normal anatomical size, contour, and position
  3. Systemically healthy individuals
  4. Healthy gingiva and periodontium around abutments (GI = 0)
  5. Good oral hygiene (PI = 0)
  6. Pocket depth ≤ 3 mm
  7. Thick gingival biotype

Exclusion criteria

Exclusion Criteria:

  1. Smokers
  2. Systemic conditions affecting periodontal status
  3. Attachment loss, bleeding on probing, or plaque accumulation
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Group A: Cordless paste with astringent (EXP)

    gingival retraction model 1 Expasyl (Acteon PVT LTD)

    Procedure: Group A: Cordless paste with astringent (EXP): Expasyl (Acteon PVT LTD)

  • Experimental
    Group B: Cordless paste without astringent (MF):

    gingival retraction model 2 Magic FoamCord (Coltene Whaledent AG)

    Procedure: Group B: Cordless paste without astringent (MF): Magic FoamCord (Coltene Whaledent AG)

  • Experimental
    Group C:Laser troughing (LT):

    gingival retraction model 3 Diode laser (iLase; Biolase Inc.)

    Procedure: Group C: Laser troughing (LT): Diode laser (iLase; Biolase Inc.)

  • Other
    Retraction cord with astringent (RCA; Control group):

    control-Knitted cord impregnated with aluminum chloride (Ultrapak + Viscostat Clear; Ultradent Inc.)

    Procedure: Group D: Retraction cord with astringent (RCA; Control group): Knitted cord impregnated with aluminum chloride (Ultrapak + Viscostat Clear; Ultradent Inc.)

Interventions

  • ProcedureGroup A: Cordless paste with astringent (EXP): Expasyl (Acteon PVT LTD)

    Chemical gingival retraction method

  • ProcedureGroup B: Cordless paste without astringent (MF): Magic FoamCord (Coltene Whaledent AG)

    Chemical gingival retraction method

  • ProcedureGroup C: Laser troughing (LT): Diode laser (iLase; Biolase Inc.)

    Gingival retraction will be performed by using only laser. Cord will not be used.

  • ProcedureGroup 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.

06

What researchers measure

Primary outcomes

  1. gingival displacement

    Vertical and horizontal gingival displacement before and after gingival retraction method will be measured by using digital caliper.

    Time frame: 30 days

07

Study locations

3 sites
  • Medial University of South Carolina
    Charleston, South Carolina 29425, United States
  • Medical University of South Carolina, College of Dental Medicine
    Charleston, South Carolina 29425, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
08

References and documents

Individual participant data

Plan to share: Yes — patient's data obtained from study

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07119281
Lead sponsor
Istanbul University
Responsible party
Dr. Merve Benli (Assos.prof.dr.merve benli, Istanbul University) — Principal investigator
First posted
Aug 13, 2025
Start date
Feb 1, 2024
Primary completion
May 4, 2025
Completion
May 4, 2025
Last update
Sep 8, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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