Evaluation of Gingival Displacement Methods

NCT07122297 | Completed

• 1 other identifier: 2015/121
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical study is being conducted to compare four different methods used to temporarily push the gums away from the teeth during dental procedures. This process, called gingival displacement, is important for dentists to clearly see and work around the tooth when placing crowns or taking impressions. The four methods being studied include: A retraction cord soaked in a special solution, A retraction paste in a capsule, A retraction paste applied with a cap, A soft tissue laser (called a diode laser). Each method is applied to teeth that need crown treatment. The goal is to find out which method moves the gum tissue the most effectively, and which one causes the least bleeding. Fifty-two teeth in total were treated using one of these four methods. Before and after treatment, gum measurements were taken to evaluate how much the gums moved and how much bleeding occurred. By studying these methods, the researchers hope to help dentists choose the most effective and least invasive technique for each patient's needs.

Conditions

Gingival Displacement

Keywords

Cord, Diode laser, Paste, Retraction

Outcome Measures

Primary Outcomes (2)

• Horizontal Gingival Displacement

  The amount of tissue movement away from the tooth surface (laterally). Measured by comparing stereomicroscopic images of polyvinyl siloxane (PVS) impressions taken before and after displacement. The horizontal gap is measured in millimeters.

  Baseline and 1 week post-displacement

• Vertical Gingival Displacement

  The amount of tissue movement in the vertical direction (apically) after using each gingival displacement method.

  Baseline and 1 week post-displacement

Secondary Outcomes (1)

• Gingival Hemorrhage

  Immediately post-displacement

Study Arms (4)

Group K

EXPERIMENTAL

Retraction cord impregnated with 15% ferric sulfate is used for gingival displacement

Procedure: Retraction cord

Group P1

EXPERIMENTAL

A retraction paste in capsule form, containing 15% aluminum chloride is used for gingival displacement.

Procedure: Retraction paste in capsule form

Group P2

EXPERIMENTAL

A retraction paste in injector form is used for gingival displacement.

Procedure: Retraction paste in injector form

Group L

EXPERIMENTAL

A diode laser is used for gingival displacement.

Procedure: Diode Laser

Interventions

Retraction cord PROCEDURE

A thin cord (type "00") was soaked in 15% ferric sulfate ferric sulfate hemostatic solution and carefully packed into the gingival sulcus. After 3 minutes, the cord was removed and the sulcus was rinsed. This is a traditional mechanical gingival displacement method.

Group K

Retraction paste in capsule form PROCEDURE

A retraction paste was applied using a capsule tip placed around the gingival margin. The paste remained in place for 3 minutes and was then rinsed off with air-water spray. This is a non-traumatic chemical displacement technique.

Group P1

Retraction paste in injector form PROCEDURE

Retractrion paste in injector form with compression cap (15% aluminum chloride) was injected into the sulcus, and a cotton compression cap was placed over the tooth. Patients gently bit on the cap for 3 minutes to apply pressure. Afterward, the paste and cap were removed and the area was rinsed. This method combines chemical and slight mechanical displacement.

Group P2

Diode Laser PROCEDURE

A 810-nm diode laser with a 400-micron fiber optic tip was used in contact mode to ablate the sulcular epithelium. The laser was operated at 1.0 W with pulsed settings. The procedure was completed by wiping the area with saline to remove residues. This technique enables precise, bloodless gingival retraction with minimal trauma.

Group L

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being over 18 years of age
• Having clinically and radiographically healthy periodontal tissues (probing depth not exceeding 3 mm, no bleeding on probing, no gingival recession, no bone loss)
• Having completed Phase I periodontal therapy
• Having no systemic disease that could affect periodontal health
• Having abutment teeth located in the canine, premolar, or molar regions
• Absence of any developmental anomalies in the abutment teeth
• Absence of age-related degenerative changes in the abutment teeth

You may not qualify if:

• Being under 18 years of age
• Having an uncontrolled or periodontal-health-affecting systemic disease
• Not having periodontally healthy tissues
• Having adjacent abutment teeth
• Having previously prepared abutment teeth
• Presence of any developmental anomaly in the abutment teeth
• Presence of age-related degenerative changes in the abutment teeth

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

MeSH Terms

Conditions

Cone-Rod Dystrophies

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Seda CENGİZ, DDS, Phd

  Professor, Counsellor for Education of Turkish Embassy in Vienna, Prinz-Eugen, Vienna, Austria.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 14, 2025
• Study Start: December 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share