Evaluation of Gingival Displacement Methods

NCT ID: NCT07122297

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-03-31

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.

Detailed Description

This study was designed to compare four different gingival displacement techniques in terms of their effectiveness in achieving both vertical and horizontal gingival retraction. The aim was to evaluate the extent of gingival tissue displacement and the associated clinical outcomes, such as bleeding, for each intervention, thereby helping clinicians select the most appropriate method in various clinical scenarios.

Systemically healthy individuals over 18 years of age requiring fixed prosthodontic treatment with abutment teeth in the canine, premolar, or molar regions were included in this study. Fifty-two teeth were randomly assigned to four groups (n=13) and prepared with an epigingival margin and chamfer finish line.

Group K: 15% ferric sulfate-impregnated retraction cord Group P1: Retraction paste in capsule form containing 15% aluminum chloride Group P2: Retraction paste in injector form containing 15% aluminum chloride with a compression cap Group L: 810-nm diode laser All teeth were prepared with an epigingival margin and chamfer finish line to standardize clinical conditions. Gingival displacement was evaluated in two dimensions: Vertical displacement was measured using a periodontal probe before and one week after gingival displacement. Horizontal displacement was assessed by taking polyvinyl siloxane impressions at the same time points. These impressions were analyzed under a stereomicroscope, and displacement was quantified using calibrated image analysis software.

Each intervention was applied following standardized protocols: In Groups K, P1, and P2, materials were applied for 3 minutes. In Group L, the diode laser was used in contact mode to ablate the sulcular epithelium using specific pulse and power settings (1.0 W, 1 ms pulse length). In addition to displacement measurements, post-displacement hemorrhage was clinically evaluated as a secondary outcome to assess tissue trauma and hemostatic effectiveness. All clinical procedures and measurements were performed by the same calibrated operator to ensure consistency.

Statistical analysis was conducted using SPSS software. The distribution of data was tested with the Shapiro-Wilk test. Inter-group comparisons were analyzed with the Kruskal-Wallis and Dunn's post hoc tests; intra-group comparisons used paired t-tests or Wilcoxon Signed Rank tests, depending on data distribution. A p-value < 0.05 was considered statistically significant.

The results are intended to guide clinicians in selecting gingival displacement techniques based on quantitative performance and clinical behavior under standardized conditions.

Conditions

Gingival Displacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group K

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

Group Type: EXPERIMENTAL

Retraction cord

Intervention Type: 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 P1

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

Group Type: EXPERIMENTAL

Retraction paste in capsule form

Intervention Type: 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 P2

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

Group Type: EXPERIMENTAL

Retraction paste in injector form

Intervention Type: 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 L

A diode laser is used for gingival displacement.

Group Type: EXPERIMENTAL

Diode Laser

Intervention Type: 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.

Interventions

Retraction cord

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.

Intervention Type: PROCEDURE

Retraction paste in capsule form

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.

Intervention Type: PROCEDURE

Retraction paste in injector form

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.

Intervention Type: PROCEDURE

Diode Laser

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zonguldak Bulent Ecevit University

OTHER

Sponsor Role: lead

Responsible Party

GAYE SAĞLAM

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seda CENGİZ, DDS, Phd

Role: STUDY_DIRECTOR

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

Other Identifiers

2015/121

Identifier Type: -

Identifier Source: org_study_id