Gingival DisplacementNCT07122297
Evaluation of Gingival Displacement Methods
A study testing Retraction cord, Retraction paste in capsule form and Retraction paste in injector form in people with Gingival Displacement, run by Zonguldak Bulent Ecevit University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Displacement
- What is being tested?
- Retraction cord, Retraction paste in capsule form and Retraction paste in injector form
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Clinical Evaluation of Different 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.
Read the 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
- Being tested
- Retraction cord, Retraction paste in capsule form, Retraction paste in injector form, Diode Laser
- Keywords
- Cord, Diode laser, Paste, Retraction
- Medical subject headings
- Cone-Rod Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retraction cordProcedure or surgery
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 formProcedure or surgery
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 formProcedure or surgery
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 LaserProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group K | Experimental | Retraction cord impregnated with 15% ferric sulfate is used for gingival displacement Receives: Procedure: Retraction cord |
| Group P1 | Experimental | A retraction paste in capsule form, containing 15% aluminum chloride is used for gingival displacement. Receives: Procedure: Retraction paste in capsule form |
| Group P2 | Experimental | A retraction paste in injector form is used for gingival displacement. Receives: Procedure: Retraction paste in injector form |
| Group L | Experimental | A diode laser is used for gingival displacement. Receives: Procedure: Diode Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 1 week post-displacement
Secondary outcomes (1)
Gingival Hemorrhage
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
Measured: Immediately post-displacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study startDec 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival DisplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GAYE SAĞLAM, Zonguldak Bulent Ecevit University
- Investigators
- Seda CENGİZ, DDS, Phd, Study director, Professor, Counsellor for Education of Turkish Embassy in Vienna, Prinz-Eugen, Vienna, Austria.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122297
- Sponsor's protocol ID
- 2015/121
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Different Gingival Displacement Methods
- ClinicalTrials.gov ID
- NCT07122297
- Acronym / sponsor ID
- 2015/121
- Conditions
- Gingival Displacement
- Keywords
- Cord, Diode laser, Paste, Retraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group K | Experimental | Procedure: Retraction cordRetraction cord impregnated with 15% ferric sulfate is used for gingival displacement |
| Group P1 | Experimental | Procedure: Retraction paste in capsule formA retraction paste in capsule form, containing 15% aluminum chloride is used for gingival displacement. |
| Group P2 | Experimental | Procedure: Retraction paste in injector formA retraction paste in injector form is used for gingival displacement. |
| Group L | Experimental | Procedure: Diode LaserA diode laser is used for gingival displacement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retraction cordA 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. | Procedure or surgery | Group K |
| Retraction paste in capsule formA 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. | Procedure or surgery | Group P1 |
| Retraction paste in injector formRetractrion 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. | Procedure or surgery | Group P2 |
| Diode LaserA 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. | Procedure or surgery | Group L |
Primary outcome
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.
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.
1 secondary outcome
Gingival Hemorrhage
Time frame: Immediately post-displacement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Gingival Displacement
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
Enrolling by invitation
Efficacy of Three Gingival Displacement Methods
Tooth Defect, Teeth Restoration
RecruitingPhase 4
Comparison of Effectiveness of Gingival Displacement Using Retraction Cord and Aluminum Chloride Gel
Gingival Bleeding, Prosthesis Failure, Dental
Recruiting
The Use of Coronary Displaced Flap and Deepithelialized Free Graft in the Treatment of Multiple Gingival Recessions
Gingival Recession Generalized Moderate
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seda CENGİZ, DDS, Phd study director
Professor, Counsellor for Education of Turkish Embassy in Vienna, Prinz-Eugen, Vienna, Austria.
Questions about this trial
What is this clinical trial studying?
A study testing Retraction cord, Retraction paste in capsule form and Retraction paste in injector form in people with Gingival Displacement, run by Zonguldak Bulent Ecevit University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal Gingival Displacement (time frame: Baseline and 1 week post-displacement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.