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Completed

NCT Number: NCT07122297

Evaluation of Gingival Displacement Methods

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. Horizontal Gingival Displacement

    Time frame: Baseline and 1 week post-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.

  2. Vertical Gingival Displacement

    Time frame: Baseline and 1 week post-displacement

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

Secondary outcomes

  1. Gingival Hemorrhage

    Time frame: Immediately post-displacement

    The amount of bleeding observed after application of the gingival displacement method.

    Gingival hemorrhage was assessed immediately after gingival displacement and removal of the applied materials from the tooth and gingiva. Bleeding was recorded using a score system:

    0 - No bleeding observed

    • - Bleeding that could be controlled within 1 minute
    • - Bleeding that could not be controlled within 1 minute

Sponsors and collaborators

Lead sponsor

Zonguldak Bulent Ecevit University

Other

Registry information

Official study title

Clinical Evaluation of Different Gingival Displacement Methods

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 14, 2025
Registry last updated
Aug 14, 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.

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