Completed

NCT Number: NCT07119281

Gingival Retraction for Digital Scan Data

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.

Completed

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Key information

Conditions

Data Accuracy, Bleeding Control

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medial University of South Carolina, Charleston, South Carolina, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Smokers
Systemic conditions affecting periodontal status
Attachment loss, bleeding on probing, or plaque accumulation

Treatment and study plan

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

Procedure

Chemical gingival retraction method

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

Procedure

Chemical gingival retraction method

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

Procedure

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

Mechanical and chemical gingival retraction method will be used.

Primary outcomes

gingival displacement

Time frame: 30 days

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

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Effect of Retraction Techniques on Scan Accuracy

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Aug 13, 2025
Registry last updated: Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.