Evaluation of Gingival Displacement Methods
- Conditions
- Gingival Displacement
- Registration Number
- NCT07122297
- Lead Sponsor
- Zonguldak Bulent Ecevit University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Horizontal Gingival Displacement 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.
Vertical Gingival Displacement Baseline and 1 week post-displacement The amount of tissue movement in the vertical direction (apically) after using each gingival displacement method.
- Secondary Outcome Measures
Name Time Method Gingival Hemorrhage 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
1. - Bleeding that could be controlled within 1 minute
2. - Bleeding that could not be controlled within 1 minute