Gingival EnlargementNCT04016064
Temperature and Healing in Treatment of Gingival Enlargement
A study testing Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgery in people with Gingival Enlargement, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
Aim: Gingival enlargement is a common clinical condition which requires surgical approaches to alleviating these enlargement areas. The aim of this study was to investigate epithelization, gingival temperature, inflammation and pain levels in post-operative healing process in 4 different gingivectomy 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?
- Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2012to 1 Dec 2013
- 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 in anterior quadrants.
Who cannot join
- pregnancy/lactation
- drug use, previous periodontal therapy within 6 months
- previous antibiotic use within 6 months, smoking
- the existence of attachment/bone loss. .
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University
Tokat Province, 60100
About this study
Official title: Evaluation of Temperature and Healing in Treatment of Gingival Enlargement Using Different Gingivectomy Techniques
Aim: Gingival enlargement is a common clinical condition which requires surgical approaches to alleviating these enlargement areas. The aim of this study was to investigate epithelization, gingival temperature, inflammation and pain levels in post-operative healing process in 4 different gingivectomy techniques including Er:YAG laser, Nd:YAG laser, electrosurgery and conventional gingivectomy in treatment of chronic inflammatory gingival enlargements.
Material and Method: A split-mouth designed study was conducted on 37 systemically healthy patients consisting of 19 females and 18 males, who had gingival enlargement areas on the left and right of maxillary and mandibular anterior regions. Gingival crevicular fluid (GCF) samples were collected, clinical periodontal parameters and gingival temperature levels were recorded at baseline and in the postoperative period. The gingival temperature was measured during surgical procedures. Gingival temperature and epithelization levels in 3rd, 7th, 10th and 15th days; GCF levels in 15th, 30th, and 90th days and pain levels in 2nd and 8th hours and between 1st-7th days of post-operative healing process were evaluated.
- Conditions
- Gingival Enlargement
- Being tested
- Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgery
- Keywords
- gingival enlargement, Er:YAG, Nd:YAG, electrosurgery
- Medical subject headings
- Gingival Hyperplasia, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgeryProcedure or surgery
- Er: YAG laser (Fotana AT Fidelis III, Ljubljana, Slovenia) 200 mj, 10 Hz, 2 Watt and VLP (long pulse, 1000 μs); 1.3 mm diameter, 8 mm long cylindrical, a sapphire tip was used with air cooling and water irrigation.
- Nd: YAG laser (Fotana AT Fidelis III, Ljubljana, Slovenia) was applied at 4 watts, 50 Hz, 300 μm microfiber tip and SP (short pulse: 180 μs) settings.
- Electrosurgical (Servotome Classic System, High Frequency Surgical Equipment, Satelec, France).
- Conventional surgical method was applied with hand instruments and gingivectomy knives.
| Study group | Role | What they receive |
|---|---|---|
| group 1; | Other | Er:YAG laser Receives: Procedure: Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgery |
| group 2 | Other | Nd:YAG laser Receives: Procedure: Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgery |
| group 3 | Other | Electrosurgery Receives: Procedure: Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epithelization
Wound surface epithelization in the healing process was evaluated with a staining solution (Mira-2-tone, GMBH \& Co., Duisburg, Germany). (O. Ozcelik et al., 2008)
Measured: Epithelization was evaluated at postoperative 7th day
Secondary outcomes (1)
Gingival temperature
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: The gingival temperature was measured during surgical procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start1 Jan 2012
- Primary completion1 May 2013
- Study completion1 Dec 2013
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study was designed as a controlled clinical study with a randomized design. The study protocol was approved by the local ethical committee of Clinical Studies of Ondokuz Mayis University. The study population consisted of 37 participants (19 women, age 23.10±2.78, 18 men age 21.11±2.63).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 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
- NCT04016064
- Sponsor's protocol ID
- OMU KAEK 2012/167
- Status last verified
- Jul 2019
- First submitted
- 8 Jul 2019
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Temperature and Healing in Treatment of Gingival Enlargement Using Different Gingivectomy Techniques
- ClinicalTrials.gov ID
- NCT04016064
- Acronym / sponsor ID
- OMU KAEK 2012/167
- Conditions
- Gingival Enlargement
- Keywords
- gingival enlargement, Er:YAG, Nd:YAG, electrosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 May 2013 (actual)
- Study completion
- 1 Dec 2013 (actual)
- First posted
- 11 Jul 2019 (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.
Aim: Gingival enlargement is a common clinical condition which requires surgical approaches to alleviating these enlargement areas. The aim of this study was to investigate epithelization, gingival temperature, inflammation and pain levels in post-operative healing process in 4 different gingivectomy techniques including Er:YAG laser, Nd:YAG laser, electrosurgery and conventional gingivectomy in treatment of chronic inflammatory gingival enlargements.
Material and Method: A split-mouth designed study was conducted on 37 systemically healthy patients consisting of 19 females and 18 males, who had gingival enlargement areas on the left and right of maxillary and mandibular anterior regions. Gingival crevicular fluid (GCF) samples were collected, clinical periodontal parameters and gingival temperature levels were recorded at baseline and in the postoperative period. The gingival temperature was measured during surgical procedures. Gingival temperature and epithelization levels in 3rd, 7th, 10th and 15th days; GCF levels in 15th, 30th, and 90th days and pain levels in 2nd and 8th hours and between 1st-7th days of post-operative healing process were evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The present study was designed as a controlled clinical study with a randomized design. The study protocol was approved by the local ethical committee of Clinical Studies of Ondokuz Mayis University. The study population consisted of 37 participants (19 women, age 23.10±2.78, 18 men age 21.11±2.63).
| Arm | Type | Receives |
|---|---|---|
| group 1; | Other | Procedure: Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgeryEr:YAG laser |
| group 2 | Other | Procedure: Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgeryNd:YAG laser |
| group 3 | Other | Procedure: Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgeryElectrosurgery |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- systemically healthy individuals
- the existence of at least 20 functioning teeth, the existence of chronic inflammatory gingival enlargement in anterior quadrants.
Key exclusion criteria (4 listed)
- pregnancy/lactation
- drug use, previous periodontal therapy within 6 months
- previous antibiotic use within 6 months, smoking
- the existence of attachment/bone loss. .
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 |
|---|---|---|
| Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgery1. Er: YAG laser (Fotana AT Fidelis III, Ljubljana, Slovenia) 200 mj, 10 Hz, 2 Watt and VLP (long pulse, 1000 μs); 1.3 mm diameter, 8 mm long cylindrical, a sapphire tip was used with air cooling and water irrigation. 2. Nd: YAG laser (Fotana AT Fidelis III, Ljubljana, Slovenia) was applied at 4 watts, 50 Hz, 300 μm microfiber tip and SP (short pulse: 180 μs) settings. 3. Electrosurgical (Servotome Classic System, High Frequency Surgical Equipment, Satelec, France). 4. Conventional surgical method was applied with hand instruments and gingivectomy knives. | Procedure or surgery | group 1;, group 2, group 3 |
Primary outcome
Epithelization
Time frame: Epithelization was evaluated at postoperative 7th day
Wound surface epithelization in the healing process was evaluated with a staining solution (Mira-2-tone, GMBH \& Co., Duisburg, Germany). (O. Ozcelik et al., 2008)
1 secondary outcome
Gingival temperature
Time frame: The gingival temperature was measured during surgical procedures
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 Jul 2019.
- Individual participant dataSharing planned: No
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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 Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional 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 2 inclusion and 4 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 Jul 2019. 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?
Epithelization (time frame: Epithelization was evaluated at postoperative 7th day). 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 Jul 2019.