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PigmentationNCT05304624

Comparison of Er,Cr:YSGG Laser and Diode Laser in the Treatment of Gingival Melanin Pigmentation

A study testing laser in people with Pigmentation, run by Okan University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main aim of this paper is to explore the efficiancy on the extention and density of pigmentation between diode and Er,Cr:YSGG lasers. The second aim of this study was to investigate the lasers effects of patient pain and comfort. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Pigmentation
What is being tested?
laser
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2020to 10 Mar 2022
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

  • Patients with systemic healthy or not taking any medication
  • Patients who are not pregnant or breastfeeding
  • Patients between 18-40 years old
  • Physiologic gingival hyperpigmentation on the facial aspect of maxillary first right premolar to first left premolar region
  • Patients with esthetic concerns
  • Patients who have smoked at least 10 cigarettes per day for at least 5 years
  • Periodontally healthy patients

Who cannot join

  • Patients with any systemic diseases or taking any medication
  • Pregnant and lactating women
  • Patients under 18 years
  • Patients without gingival melanin pigmentation on the facial aspect of maxillary first right premolar to first left premolar region
  • Patients who smoke less than 5 years and/or less than 10 cigarettes per day
  • Non-smokers
  • Patients with any metallic restoration or undergoing orthodontic treatment

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul Okan University

    Istanbul, Tuzla, 34947

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Er,Cr:YSGG Laser and Diode Laser in the Treatment of Gingival Melanin Pigmentation: Randomised Clinical Trial

The main aim of this paper is to explore the efficiancy on the extention and density of pigmentation between diode and Er,Cr:YSGG lasers. The second aim of this study was to investigate the lasers effects of patient pain and comfort.

Read the detailed description

Recently, soft tissue aesthetics has become an important issue in dentistry. The normal physiological color of the gingiva is coral pink or pale pink. The color of gingiva is determined by several factors, including thickness of ephitelium, degree of keratinization, the number and size of underlying blood vessels and pigments within the epithelium. Gingival hyperpigmentation is caused by excessive deposition of melanin located in the basal and suprabasal cell layers of the epithelium. Many etiological factors such as smoking can stimulate melanin pigmentation. It has been reported that polycyclic amines such as nicotine and benzopyrene, which are known to penetrate melanocytes and bind to melanin, in cigarettes cause stimulation of melanocytes and as a result increase melanin production. Smoker melanocyte pigmentation was described first time by Hedin in 1977 as 'a local benign melanin pigmentation often seen in the attached gingiva'. Although physiologic melanin pigmentation and smoker melanosis are not medical problems, patients seek treatment for esthetic purposes. Various depigmentation techniques are employed to address the aesthetic concerns of individuals. Methods used for depigmentation: Chemical treatment, electrosurgery, abrasion with diamond tools, scalpel technique, gingivectomy, gingival graft, cryosurgery and lasers. Which method to choose depends on clinical experience and individual preferences. However, most researchers consider laser ablation to be more effective, convenient, and safer for gingival depigmentation. Many laser systems such as CO2 laser, Diyot laser, Neodymium Doped:Yttrium Aluminum Garnet(Nd:YAG) laser, Erbium Doped:Yttrium Aluminum Garnet(Er:YAG) laser and Erbium Chromium-Doped:Yttrium, Scandium, Gallium, Garnet(Er,Cr:YSGG) are used for this purpose. In melanin depigmentation with laser, the ability melanocytes which containing melanin to absorb the laser beam depends on the wavelength and water. The wavelength of the Er,Cr:YSGG laser is 2780nm, while the wavelength of the diode laser is 810-980nm.10 While diode laser is used for soft tissue surgery, Er,Cr:YSGG laser is used for soft and hard tissue surgery. Although there are more case reports regarding the use of diode lasers in gingival depigmentation, only a few focus on the use of Er, Cr:YSGG laser. In this study; in the treatment of gingival depigmentation by use of Er, Cr: YSGG laser and Diode laser to patients, it was aimed to evaluate the satisfaction of the patients during and after the operation, to evaluate the change in gingival tissue thickness and to evaluate the rate of repigmentation.

Conditions
Pigmentation
Being tested
laser
Keywords
Er,Cr:YSGG laser, Diode Laser, Gingival pigmentation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • laserDevice

    these lasers are routinely used in dental practice

Study groups in NCT05304624
Study groupRoleWhat they receive
Group 1: ErCr:YSGG laserActive comparatorWaterlase iPlus,Biolase-USA Er,Cr:YSGG laser (2780nm) was set at frequency 50Hz, power of 2.5W and 1562.5 W/cm2. MZ6 (400µm fiber tip) was used in contact mode for de-epitelization procedure. Another visit of laser ablation was performed after 7 days to remove the remaining pigmentation. The same laser settings were used.
Receives: Device: laser
Group 2: Diode laserExperimentalIlase, Biolase-USA Diode laser (940nm) was set at power of 1.2W and 750 W/cm2. 400µm fiber tip was used in contact mode and continuous-wave for de-epitelization procedure. Another visit of laser ablation was performed after 7 days to remove the remaining pigmentation. The same laser settings were used.
Receives: Device: laser

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. depigmentation with two different laser devices

    Dummett Oral Pigmentasyon Indeks (DOPI) tehat identifies pigmentation as score 1- no clinical pigmentation (pink tissue), score 2-mild clinical pigmentation (light brown), score 3-moderate clinical pigmentation (mixed brown and pink), and score 4-heavy clinical pigmentation (deep brown to bluish black).

    Photographic Image Assesment: All photographs were taken in a standardized environment by using a Canon EOS 700D with Macro Lens EF 100 mm with automatic focusing. All photographs were taken at a standard distance which was 30 cm as recorded from the patient's cental teeth to the edge of the camera lens. The periodontal probe was used for the calibration of intraoral photographs. Photographs were analyzed with ImageJ Software version10.2. The pigmented areas on the photograph will be calculated in mm2.

    Measured: 1 year

Secondary outcomes (2)

  1. Pain Perception

    The visual analog scale (VAS) was used at intraoperatively, 1st day and 1st week post-operative visits to measure the intensity of pain experienced during and after the treatment. The patients were asked to rate the degree of pain, on a 10 cm horizontal VAS by placing a vertical mark to assess position between the two end-points (from no-pain to severe-pain).

    Measured: 1 year

  2. Patient Esthetic Satisfaction

    Another VAS was used in the 12th month for evaluation of patient esthetic satisfaction. The patients were asked to rate the degree of esthetic satisfaction, on a 10 cm horizontal VAS by placing a vertical mark to assess position between the two end-points (from not at all to very satisfied).

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start1 Dec 2020
  3. Primary completion1 Mar 2022
  4. Study completion10 Mar 2022

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05304624
Sponsor's protocol ID
E-68869993-511
Status last verified
Mar 2022
First submitted
11 Mar 2022
Last updated
31 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Besiroglu-Turgut E, Kayaalti-Yuksek S. Comparison of Er,Cr:YSGG laser and diode laser in the treatment of gingival melanin pigmentation: a randomized clinical trial. Lasers Med Sci. 2023 Feb 27;38(1):79. doi: 10.1007/s10103-023-03738-w.

    PubMed 36847909

Questions about this trial

What is this clinical trial studying?

A study testing laser in people with Pigmentation, run by Okan 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 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 31 Mar 2022. 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?

depigmentation with two different laser devices (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05304624, which also lists 1 linked publication.

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 31 Mar 2022.

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