Gingival EnlargementNCT04304391
Evaluation of Healing Process After Laser Asissted Gingivectomy Techniques
A study testing Resective Gingival Surgery in people with Gingival Enlargement, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The aim of this study was to evaluate and determine clinical and biochemical comparison of 3 different methods including Er:YAG laser, diod laser, and conventional techniques. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Enlargement
- What is being tested?
- Resective Gingival Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 15 Feb 2020
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- systemically healthy individuals
- the existence of at least 20 functioning teeth,
- the existence of chronic inflammatory gingival enlargement
Who cannot join
- pregnancy/lactation,
- drug use,
- previous periodontal therapy within 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University
Tokat Province, 60100
About this study
Official title: The Determination of the Operative Temperature Levels Using Er:YAG Laser and Diode Laser Supported Resective Gingival Surgery and the Clinical and Biochemical Evaluation of it's Effect on Postoperative Imflammation, Epithelization and Pain
Objective: The aim of this study was to evaluate and determine clinical and biochemical comparison of 3 different methods including Er:YAG laser, diod laser, and conventional techniques.
Method: This study was conducted on 32 female, 13 male, a total of 45 individuals (study group patients) with an indication of resective gingival surgery in the anterior region of the maxillar anterior regions and 11 female, 4 men, a total of 15 individuals (negative control group patients) with a healthy gingiva. Clinical periodontal parameters, gingival crevicular fluid (GCF) KGF-2 and VEGF-A levels and gingival temperature levels were recorded before the investigation and during operations with 3 different techniques, gingival temperature was measured. Gingival temperature and epithelization levels in 3, 7, 14 and 21 days; GCF KGF-2 and VEGF-A levels in 14 and 21 days and pain levels between 1-7 days of post-operative healing process were evaluated. Preoperative anxiety and postoperative satisfaction were evaluated through questionnaires
Read the detailed description
Objective: The aim of this study was to evaluate and determine clinical and biochemical comparison of 3 different methods including Er:YAG laser, diod laser, and conventional techniques commonly used in resective gingival surgeries in terms of preoperative anxiety, postoperative satisfaction, epithelization, gingival temperature, inflammation and pain levels in post-operative healing process.
Method: This study was conducted on 32 female, 13 male, a total of 45 individuals (study group patients) with an indication of resective gingival surgery in the anterior region of the maxillar anterior regions and 11 female, 4 men, a total of 15 individuals (negative control group patients) with a healthy gingiva. Clinical periodontal parameters, gingival crevicular fluid (GCF) KGF-2 and VEGF-A levels and gingival temperature levels were recorded before the investigation and during operations with 3 different techniques, gingival temperature was measured. Gingival temperature and epithelization levels in 3, 7, 14 and 21 days; GCF KGF-2 and VEGF-A levels in 14 and 21 days and pain levels between 1-7 days of post-operative healing process were evaluated. Preoperative anxiety and postoperative satisfaction were evaluated through questionnaires
- Conditions
- Gingival Enlargement
- Being tested
- Resective Gingival Surgery
- Medical subject headings
- Gingival Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resective Gingival SurgeryProcedure or surgery
Gingivectomy and gingivoplasty:Resective gingival surgical procedured
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Conventional Gingivectomy:Technique is performed with conventional surgical instruments. Receives: Procedure: Resective Gingival Surgery |
| Group B | Experimental | Diode Laser Assisted Gingivectomy: Technique is performed with using diode laser. Receives: Procedure: Resective Gingival Surgery |
| Group C | Experimental | Er:YAG Laser Assisted Gingivectomy: Technique is performed with using Er:YAG laser. Receives: Procedure: Resective Gingival Surgery |
| Group D | No intervention | Negative Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Gingival Temperature
Operative and post operative gingival temperature levels of the application region measured and recorded with using a noncontact infrared thermometer. The temperature measurement during the process was performed by an infrared thermometer (Optris GMBH, Manuel LS, Berlin, Germany). The device had a measurement and recording range from -35 ° C to 900 ° C, optical resolution 75: 1, thermal resolution 0.1 ° C, waveband range 8-14, USB interface and graphical software program.
Measured: 6 months
Evaluation of Gingival Epithelization
Epithelization levels of resection region were measured and evaluated with using Image J software. Wound surface epithelization in the healing process was evaluated with a staining solution (Mira-2-tone, GMBH \& Co., Duisburg, Germany). The treatment area was isolated. The solution carrier was applied with cotton pellets. The excess solution was removed by air-water spray. The standardized photographs were taken and transferred to the java based analysis program (Image J 1.31o, National Institutes of Health, Bethesda, MD, USA). The dark stained areas were calculated in the computer environment
Measured: 6 months
Secondary outcomes (1)
Evaluation of Gingival Pain Levels: Visual Analog Scale
Pain levels were evaluated with Visual Analog Scale in post operative process.A visual analogue scale (VAS) was used to evaluate pain after surgeries. Patients were asked to mark the pain levels at the levels from 0 (no pain) to 10 (the most severe pain) on the scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start1 Feb 2019
- Primary completion1 Feb 2020
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival EnlargementStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mehmet murat taskan, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304391
- Sponsor's protocol ID
- TOGUGKARA
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2020
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Determination of the Operative Temperature Levels Using Er:YAG Laser and Diode Laser Supported Resective Gingival Surgery and the Clinical and Biochemical Evaluation of it's Effect on Postoperative Imflammation, Epithelization and Pain
- ClinicalTrials.gov ID
- NCT04304391
- Acronym / sponsor ID
- TOGUGKARA
- Conditions
- Gingival Enlargement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 11 Mar 2020 (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.
Objective: The aim of this study was to evaluate and determine clinical and biochemical comparison of 3 different methods including Er:YAG laser, diod laser, and conventional techniques.
Method: This study was conducted on 32 female, 13 male, a total of 45 individuals (study group patients) with an indication of resective gingival surgery in the anterior region of the maxillar anterior regions and 11 female, 4 men, a total of 15 individuals (negative control group patients) with a healthy gingiva. Clinical periodontal parameters, gingival crevicular fluid (GCF) KGF-2 and VEGF-A levels and gingival temperature levels were recorded before the investigation and during operations with 3 different techniques, gingival temperature was measured. Gingival temperature and epithelization levels in 3, 7, 14 and 21 days; GCF KGF-2 and VEGF-A levels in 14 and 21 days and pain levels between 1-7 days of post-operative healing process were evaluated. Preoperative anxiety and postoperative satisfaction were evaluated through questionnaires
Detailed description
Objective: The aim of this study was to evaluate and determine clinical and biochemical comparison of 3 different methods including Er:YAG laser, diod laser, and conventional techniques commonly used in resective gingival surgeries in terms of preoperative anxiety, postoperative satisfaction, epithelization, gingival temperature, inflammation and pain levels in post-operative healing process.
Method: This study was conducted on 32 female, 13 male, a total of 45 individuals (study group patients) with an indication of resective gingival surgery in the anterior region of the maxillar anterior regions and 11 female, 4 men, a total of 15 individuals (negative control group patients) with a healthy gingiva. Clinical periodontal parameters, gingival crevicular fluid (GCF) KGF-2 and VEGF-A levels and gingival temperature levels were recorded before the investigation and during operations with 3 different techniques, gingival temperature was measured. Gingival temperature and epithelization levels in 3, 7, 14 and 21 days; GCF KGF-2 and VEGF-A levels in 14 and 21 days and pain levels between 1-7 days of post-operative healing process were evaluated. Preoperative anxiety and postoperative satisfaction were evaluated through questionnaires
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Resective Gingival SurgeryConventional Gingivectomy:Technique is performed with conventional surgical instruments. |
| Group B | Experimental | Procedure: Resective Gingival SurgeryDiode Laser Assisted Gingivectomy: Technique is performed with using diode laser. |
| Group C | Experimental | Procedure: Resective Gingival SurgeryEr:YAG Laser Assisted Gingivectomy: Technique is performed with using Er:YAG laser. |
| Group D | No intervention | –Negative Control Group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- systemically healthy individuals
- the existence of at least 20 functioning teeth,
- the existence of chronic inflammatory gingival enlargement
Key exclusion criteria (3 listed)
- pregnancy/lactation,
- drug use,
- previous periodontal therapy within 6 months
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 |
|---|---|---|
| Resective Gingival SurgeryGingivectomy and gingivoplasty:Resective gingival surgical procedured | Procedure or surgery | Group A, Group B, Group C |
Primary outcome
Evaluation of Gingival Temperature
Time frame: 6 months
Operative and post operative gingival temperature levels of the application region measured and recorded with using a noncontact infrared thermometer. The temperature measurement during the process was performed by an infrared thermometer (Optris GMBH, Manuel LS, Berlin, Germany). The device had a measurement and recording range from -35 ° C to 900 ° C, optical resolution 75: 1, thermal resolution 0.1 ° C, waveband range 8-14, USB interface and graphical software program.
Evaluation of Gingival Epithelization
Time frame: 6 months
Epithelization levels of resection region were measured and evaluated with using Image J software. Wound surface epithelization in the healing process was evaluated with a staining solution (Mira-2-tone, GMBH \& Co., Duisburg, Germany). The treatment area was isolated. The solution carrier was applied with cotton pellets. The excess solution was removed by air-water spray. The standardized photographs were taken and transferred to the java based analysis program (Image J 1.31o, National Institutes of Health, Bethesda, MD, USA). The dark stained areas were calculated in the computer environment
1 secondary outcome
Evaluation of Gingival Pain Levels: Visual Analog Scale
Time frame: 6 months
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 11 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resective Gingival Surgery in people with Gingival Enlargement, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Evaluation of Gingival Temperature (time frame: 6 months). 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 11 Mar 2020.