NCT05304624

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 11, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

March 11, 2022

Last Update Submit

March 30, 2022

Conditions

Pigmentation

Keywords

Er,Cr:YSGG laserDiode LaserGingival pigmentation

Outcome Measures

Primary Outcomes (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.

    1 year

Secondary Outcomes (2)

  • Pain Perception

    1 year

  • Patient Esthetic Satisfaction

    1 year

Study Arms (2)

Group 1: ErCr:YSGG laser

ACTIVE COMPARATOR

Waterlase 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.

Device: laser

Group 2: Diode laser

EXPERIMENTAL

Ilase, 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.

Device: laser

Interventions

laserDEVICE

these lasers are routinely used in dental practice

Group 1: ErCr:YSGG laserGroup 2: Diode laser

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Okan University

Istanbul, Tuzla, 34947, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 36847909DERIVED

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Ekin Beşiroğlu

    Istanbul Okan University, Istanbul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant profesor

Study Record Dates

First Submitted

March 11, 2022

First Posted

March 31, 2022

Study Start

December 1, 2020

Primary Completion

March 1, 2022

Study Completion

March 10, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)