Gingival Retraction for Digital Scan Data

Not Applicable

Completed

• Conditions: Data Accuracy, Bleeding Control

• Registration Number: NCT07119281
• Lead Sponsor: Istanbul University

Brief 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.

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 50 systemically and periodontally healthy participants were randomly assigned to one of five groups, each using a different retraction method:

Group A: Expasyl™ paste (cordless, chemico-mechanical)

Group B: Magic FoamCord® with compression cap (cordless, mechanical)

Group C: 3M™ Astringent Retraction Paste (cordless, chemical)

Group D: Double cord + aluminum chloride (conventional, mechanical + chemical)

Group E: Single cord only (conventional, mechanical)

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 Timeline

• Study Start: 2024-02-01
• Primary Completion: 2025-05-04
• Study Completion: 2025-05-04
• Study First Submitted: 2025-07-21
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-06
• Last Update Submitted: 2025-08-06
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age 18-65
• Periodontally healthy anterior teeth (central incisor to canine)
• No gingival inflammation (Bleeding Index = 0)
• No prosthetic restorations in the region
• Thick or medium biotype based on visual assessment

Exclusion Criteria

• Systemic disease affecting soft tissue response
• History of periodontal surgery
• Anticoagulant medication use
• Smokers or patients with poor oral hygiene

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
gingival displacement	30 days	Vertical and horizontal gingival displacement before and after gingival retraction method will be measured by using digital caliper.

Trial Locations

Locations (3)

Medial University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Medical University of South Carolina, College of Dental Medicine; 🇺🇸 Charleston, South Carolina, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States