Efficacy of Three Gingival Displacement Methods

NCT07282977 | Enrolling By Invitation

• 1 other identifier: HenanPPH
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to find the best gingival displacement method for taking impressions of artificial full crowns with subgingival margins. The main question it aims to answer is: Which of the three common gingival displacement methods works best? Researchers will compare three methods: gingival retraction cord, gingival retraction paste, and gingival retraction cord + hemostatic gel, to see which is optimal. Participants will: Receive one of the three gingival displacement treatments during impression taking. Fill out a VAS form to rate their pain.

Conditions

Tooth Defect; Teeth Restoration

Keywords

gingival displacement; gingival retraction; gingival retraction cord; gingival retraction paste; hemostatic gel

Outcome Measures

Primary Outcomes (1)

• horizontal sulcus width of gingival displacement

  After tooth preparation, gingival displacement material was applied to each group and then silicone impressions were taken using the two-step impression technique, and die stone models were poured.The horizontal displacement width of the sulcus was measured on the cast, defined as the linear distance between the margin of the prepared tooth and the adjacent gingival replica on the cast. The mearsurement procedure was carried out with an optical microscope.

  baseline

Secondary Outcomes (2)

• gingival sulcus bleeding

  baseline

• patient- reported pain

  baseline

Study Arms (3)

gingival retration cord

EXPERIMENTAL

give the patients in this group the gingival displacemet treatment with retraction cord

Procedure: gingival retraction cord

gingival retraction paste

EXPERIMENTAL

give the patients in this group the gingival displacemet treatment with retraction paste

Procedure: gingival retraction paste

gingival retration cord+ hemostatic gel

EXPERIMENTAL

give the patients in this group the gingival displacemet treatment with retraction cord impregnated with hemostatic gel

Procedure: gingival retraction cord+hemostatic gel

Interventions

gingival retraction cord PROCEDURE

After tooth preparation, the prepared abutment tooth was rinsed and dried. A preliminary impression was taken using heavy-body silicone. An appropriately sized retraction cord (Ultrapak, #000-#0) was selected and gently packed into the gingival sulcus of the prepared tooth using a cord packer. The cord was left in the gingival sulcus for 7-8 minutes. Following cord removal, light-body silicone was immediately injected around the gingival sulcus of the prepared abutment tooth and into the preliminary impression tray, followed by seating of the preliminary impression tray to obtain the final impression.

gingival retration cord

gingival retraction paste PROCEDURE

After tooth preparation, the prepared abutment tooth was rinsed and dried. A preliminary impression was taken using heavy-body silicone. Retraction paste was injected into the gingival sulcus surrounding the prepared abutment tooth. The retraction paste was left in place for 2 minutes per the manufacturer's instructions, then thoroughly rinsed, and the prepared abutment tooth was air-dried. Light-body silicone was immediately injected around the gingival sulcus and into the preliminary impression tray, followed by seating of the preliminary impression tray to obtain the final impression.

gingival retraction paste

gingival retraction cord+hemostatic gel PROCEDURE

Appropriately sized retraction cords (Ultrapak, sizes #000-#0) were pre-soaked in hemostatic gel prior to use. After tooth preparation, the prepared abutment tooth was rinsed and dried. A preliminary impression was taken using heavy-body silicone. The gel-soaked retraction cords were gently packed into the gingival sulcus using a cord packer. After 7-8 minutes, the cords were removed, followed by rinsing and drying of the prepared abutment tooth. Light-body silicone was immediately injected around the gingival sulcus and into the preliminary impression tray, followed by seating of the preliminary impression tray to obtain the final impression.

gingival retration cord+ hemostatic gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• need for single crown restoration of maxillary anterior teeth, healthy periodontal status, and subgingival preparation margins on the buccal surface of the affected teeth.

You may not qualify if:

• requirement for more than one restoration, restoration in other dental quadrants, and supragingival preparation margins.

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Study Sites (1)

department of stomatology, Henan provincial people's hospital, People's hospital Henan university.

Zhengzhou, Henan, 450000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 15, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)