Hyperpigmentation; MelaninNCT04680806
Laser-Assisted Gingival Depigmentation
A study testing Er,Cr:YSGG laser 2780 nm and Diode laser 940 nm in people with Hyperpigmentation; Melanin and Laser-Induced Hyperpigmentation, run by Academy of Laser Dentistry - Gulf Laser Chapter at 1 site in Qatar.
Trial summary
This randomized clinical trial evaluated the recurrence rates of physiological gingival pigments during 24 months follow-up and the patient perceptions after the ablative depigmentation using two laser wavelengths; Diode 940 nm and Er,Cr:YSGG 2780 nm. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperpigmentation; Melanin, Laser-Induced Hyperpigmentation
- What is being tested?
- Er,Cr:YSGG laser 2780 nm and Diode laser 940 nm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteQatar
- Study dates
- 5 Apr 2015to 20 Oct 2019
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patient exhibiting physiologic pigmentation of score2 or more according to Oral pigmentation index (DOPI)
Who cannot join
- Pathologic hyperpigmentation
- Participants with a systemic condition that could affect tissue healing (e. g., autoimmune diseases)
- Pregnancy and lactation
- History of smoking
- Previous mucogingival surgery at the region to be treated
- No contraindication for the laser treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gingival Depigmentation With Er,Cr:YSGG and Diode Laser: Randomized Clinical Trial to Evaluate the Repigmentation and Patient Perceptions
This randomized clinical trial evaluated the recurrence rates of physiological gingival pigments during 24 months follow-up and the patient perceptions after the ablative depigmentation using two laser wavelengths; Diode 940 nm and Er,Cr:YSGG 2780 nm.
Read the detailed description
This study aim to compare the clinical outcomes, the rate of repigmentation, and the patient perceptions after laser-assisted gingival depigmentation with diode 940 nm and Erbium, chromium-doped yttrium, scandium, gallium and garnet (Er,Cr:YSGG) 2780 nm. Two pigmentation index were used to compare between the treatment outcomes of using Diode laser or Er,Cr:YSGG.
The depigmentation procedure essentially involves ablation of epithelial layer of buccal gingiva containing melanin pigmentation.
Sixty healthy patients (22 males and 38 females, aged 21 to 43 years) who presented with a chief complaint of having dark-brown to black gingival hyperpigmentation between April 2015 and September 2018. Participants were randomly divided into 2 groups (30 patients each). Randomization was carried out using randomization table; by a computer-generated randomization list (SPSS v23.0) with allocation ratio 1:1.
All of the patients were selected according to the study inclusion and exclusion criteria.
Data collection was done by a dental specialist who was blinded about the provided treatment. Data collections included the clinical examination at baseline and follow up appointments. To achieve blinding, three calibrated external experts, blinded to the provided treatment classified the degree of gingival pigments and gingival topography according oral pigmentation index (DOPI) and melanin pigmentation index.
The periodontal surgery was performed by a periodontist specialised in laser dentistry. The periodontist did not interfere with the treatment option.
Descriptive statistics and statistical analysis was done by an external expert using SPSS Statistics software(SPSS v23.0) . Nonparametric tests, Kruskal-Wallis test was used to compare between the two groups according the time intervals.
The patients who did not show in all the study follow up's appointments were dropped from the data analysis.
Patients were asked to evaluate the procedure by using a self-administered questionnaire. The patients were recalled after 1 week, 1 month, 12 months and 24 months.
- Being tested
- Er,Cr:YSGG laser 2780 nm, Diode laser 940 nm
- Keywords
- Depigmentation, Gingival Hyperpigmentation, Diode laser, Er,Cr:YSGG laser, Repigmentation
- Medical subject headings
- Hyperpigmentation, Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er,Cr:YSGG laser 2780 nmDevice
The depigmentation procedure essentially involves laser ablation of epithelial layer of buccal gingiva containing melanin pigmentation.
Diode laser 940 nmDevice
The depigmentation procedure essentially involves laser ablation of epithelial layer of buccal gingiva containing melanin pigmentation.
| Study group | Role | What they receive |
|---|---|---|
| Er,Cr:YSGG laser 2780 nm | Experimental | Group A was treated by an Er,Cr:YSGG laser 2780 nm cylindrical tip (tip 600 μm, 45 millijoule /pulse, average power 2.25 W, frequency 50 Hz, pulse duration 60 µs, energy density 43 J/cm2, water 50%, and air 40%). The procedure was performed completely without anesthesia with the laser tip at angulation ~30° and distance of ~1 mm from the gingival tissue. The laser tip was advancing in scanning movement from in the cervical-apical direction in all pigmented areas. The following settings was used to achieve hemostasis in case of the bleeding was present (tip 600 μm, 30 millijoule /pulse, average power 1.5 W, frequency 50 Hz, pulse duration 700 µs, energy density 28.7 J/cm2, water 10%, and air 20%). Receives: Device: Er,Cr:YSGG laser 2780 nm |
| Diode laser 940 nm | Experimental | Group B was treated with diode 940 nm Laser. The procedure was performed with a pencil-sized handpiece containing a 400 µm lasing fiber (400 μm initiated tip, average power 0.8 watts, Pulsed mode, Duty cycle 20%, Pulse duration 10 μs, energy density 636.9 J/cm2 per second, no water or air). Infiltration anesthesia was injected for B group . The laser tip was placed in angle ~30° with the gingival surface. Short light paint brush strokes were used in the cervical-apical direction in all pigmented areas. Receives: Device: Diode laser 940 nm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral pigmentation index (DOPI)
- Score 1: No clinical pigmentation (pink-colored gingiva)
- Score 2: Mild clinical pigmentation (mild light brown color)
- Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown color)
- Score 4: Heavy clinical pigmentation (deep brown or bluish black color)
Measured: Baseline
Oral pigmentation index (DOPI)
- Score 1: No clinical pigmentation (pink-colored gingiva)
- Score 2: Mild clinical pigmentation (mild light brown color)
- Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown color)
- Score 4: Heavy clinical pigmentation (deep brown or bluish black color)
Measured: 1 month post-operative
Oral pigmentation index (DOPI)
- Score 1: No clinical pigmentation (pink-colored gingiva)
- Score 2: Mild clinical pigmentation (mild light brown color)
- Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown color)
- Score 4: Heavy clinical pigmentation (deep brown or bluish black color)
Measured: 1 year follow-up
Oral pigmentation index (DOPI)
- Score 1: No clinical pigmentation (pink-colored gingiva)
- Score 2: Mild clinical pigmentation (mild light brown color)
- Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown color)
- Score 4: Heavy clinical pigmentation (deep brown or bluish black color)
Measured: 2 years follow-up
Melanin pigmentation index:
- Score 0: No pigmentation
- Score 1: Solitary unit(s) of pigmentation in papillary gingiva without extension between neighboring solitary units
- Score 2: Formation of continuous ribbon extending from neighboring solitary units
Measured: Baseline
Melanin pigmentation index:
- Score 0: No pigmentation
- Score 1: Solitary unit(s) of pigmentation in papillary gingiva without extension between neighboring solitary units
- Score 2: Formation of continuous ribbon extending from neighboring solitary units
Measured: 1 month post-operative
Melanin pigmentation index:
- Score 0: No pigmentation
- Score 1: Solitary unit(s) of pigmentation in papillary gingiva without extension between neighboring solitary units
- Score 2: Formation of continuous ribbon extending from neighboring solitary units
Measured: 1 year follow-up
Melanin pigmentation index:
- Score 0: No pigmentation
- Score 1: Solitary unit(s) of pigmentation in papillary gingiva without extension between neighboring solitary units
- Score 2: Formation of continuous ribbon extending from neighboring solitary units
Measured: 2 years follow-up
Gingival Appearance
- Score 1:Pink vital appearance for the gingiva
- Score 2: Pale Non-vital appearance for gingiva
Measured: 1 month
Secondary outcomes (4)
Oral Hygiene Index
The Oral Hygiene Index is composed of the combined Debris Index and Calculus index, each of these index is in turn based on 12 numerical determinations representing the amount of debris or calculus found on the buccal and lingual surfaces of each of three segments of each dental arch.
Criteria for classifying debris 0 No debris or stain present
- Soft debris covering not more than one third of the tooth surface, or presence of extrinsic stains without other debris regardless of surface area covered
- Soft debris covering more than one third, but not more than two thirds, of the exposed tooth surface.
- Soft debris covering more than two thirds of the exposed tooth surface.
Measured: Baseline
Oral Hygiene Index
The Oral Hygiene Index is composed of the combined Debris Index and Calculus index, each of these index is in turn based on 12 numerical determinations representing the amount of debris or calculus found on the buccal and lingual surfaces of each of three segments of each dental arch.
Criteria for classifying debris 0 No debris or stain present
- Soft debris covering not more than one third of the tooth surface, or presence of extrinsic stains without other debris regardless of surface area covered
- Soft debris covering more than one third, but not more than two thirds, of the exposed tooth surface.
- Soft debris covering more than two thirds of the exposed tooth surface.
Measured: 1 month post-operative
Gingival Index
The Gingival Index (Löe and Silness, 1963) was created for the assessment of the gingival condition and records qualitative changes in the gingiva. It scores the marginal and interproximal tissues separately on the basis of 0 to 3. The criteria are:
0= Normal gingiva;
1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.
Measured: Baseline
Gingival Index
The Gingival Index (Löe and Silness, 1963) was created for the assessment of the gingival condition and records qualitative changes in the gingiva. It scores the marginal and interproximal tissues separately on the basis of 0 to 3. The criteria are:
0= Normal gingiva;
1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.
Measured: 1 month post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start5 Apr 2015
- Primary completion30 Sep 2018
- Study completion20 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hyperpigmentation; MelaninStudies 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
- Model description
- Participants were randomly allocated to the two treatment groups: -Group A was treated by an Er,Cr:YSGG laser 2780 nm. -Group B: was treated with diode 940 nm Laser.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academy of Laser Dentistry - Gulf Laser Chapter
- Sponsor type
- University, hospital or other
- Collaborators
- Damascus University
- Responsible party
- Sponsor
- Investigators
- Omar Hamadah, PhD, Study director, Damascus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680806
- Sponsor's protocol ID
- GulfLaserChapter
- Status last verified
- Dec 2020
- First submitted
- 15 Dec 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: there is no plan to make individual participant data (IPD) available
Publications
Simsek Kaya G, Yapici Yavuz G, Sumbullu MA, Dayi E. A comparison of diode laser and Er:YAG lasers in the treatment of gingival melanin pigmentation. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Mar;113(3):293-9. doi: 10.1016/j.tripleo.2011.03.005. Epub 2011 Jun 12.
PubMed 22676819Nammour S, El Mobadder M, Namour M, Namour A, Rompen E, Maalouf E, Brugnera Junior A, Brugnera AP, Vescovi P, Zeinoun T. A Randomized Comparative Clinical Study to Evaluate the Longevity of Esthetic Results of Gingival Melanin Depigmentation Treatment Using Different Laser Wavelengths (Diode, CO2, and Er:YAG). Photobiomodul Photomed Laser Surg. 2020 Mar;38(3):167-173. doi: 10.1089/photob.2019.4672. Epub 2020 Jan 17.
PubMed 31951510Hegde R, Padhye A, Sumanth S, Jain AS, Thukral N. Comparison of surgical stripping; erbium-doped:yttrium, aluminum, and garnet laser; and carbon dioxide laser techniques for gingival depigmentation: a clinical and histologic study. J Periodontol. 2013 Jun;84(6):738-48. doi: 10.1902/jop.2012.120094. Epub 2012 Sep 24.
PubMed 23003920
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Depigmentation With Er,Cr:YSGG and Diode Laser: Randomized Clinical Trial to Evaluate the Repigmentation and Patient Perceptions
- ClinicalTrials.gov ID
- NCT04680806
- Acronym / sponsor ID
- GulfLaserChapter
- Keywords
- Depigmentation, Gingival Hyperpigmentation, Diode laser, Er,Cr:YSGG laser, Repigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Academy of Laser Dentistry - Gulf Laser ChapterUniversity, hospital or other
- Collaborators
- Damascus University
- Study start
- 5 Apr 2015 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 20 Oct 2019 (actual)
- First posted
- 23 Dec 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.
This randomized clinical trial evaluated the recurrence rates of physiological gingival pigments during 24 months follow-up and the patient perceptions after the ablative depigmentation using two laser wavelengths; Diode 940 nm and Er,Cr:YSGG 2780 nm.
Detailed description
This study aim to compare the clinical outcomes, the rate of repigmentation, and the patient perceptions after laser-assisted gingival depigmentation with diode 940 nm and Erbium, chromium-doped yttrium, scandium, gallium and garnet (Er,Cr:YSGG) 2780 nm. Two pigmentation index were used to compare between the treatment outcomes of using Diode laser or Er,Cr:YSGG.
The depigmentation procedure essentially involves ablation of epithelial layer of buccal gingiva containing melanin pigmentation.
Sixty healthy patients (22 males and 38 females, aged 21 to 43 years) who presented with a chief complaint of having dark-brown to black gingival hyperpigmentation between April 2015 and September 2018. Participants were randomly divided into 2 groups (30 patients each). Randomization was carried out using randomization table; by a computer-generated randomization list (SPSS v23.0) with allocation ratio 1:1.
All of the patients were selected according to the study inclusion and exclusion criteria.
Data collection was done by a dental specialist who was blinded about the provided treatment. Data collections included the clinical examination at baseline and follow up appointments. To achieve blinding, three calibrated external experts, blinded to the provided treatment classified the degree of gingival pigments and gingival topography according oral pigmentation index (DOPI) and melanin pigmentation index.
The periodontal surgery was performed by a periodontist specialised in laser dentistry. The periodontist did not interfere with the treatment option.
Descriptive statistics and statistical analysis was done by an external expert using SPSS Statistics software(SPSS v23.0) . Nonparametric tests, Kruskal-Wallis test was used to compare between the two groups according the time intervals.
The patients who did not show in all the study follow up's appointments were dropped from the data analysis.
Patients were asked to evaluate the procedure by using a self-administered questionnaire. The patients were recalled after 1 week, 1 month, 12 months and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly allocated to the two treatment groups: -Group A was treated by an Er,Cr:YSGG laser 2780 nm. -Group B: was treated with diode 940 nm Laser.
| Arm | Type | Receives |
|---|---|---|
| Er,Cr:YSGG laser 2780 nm | Experimental | Device: Er,Cr:YSGG laser 2780 nmGroup A was treated by an Er,Cr:YSGG laser 2780 nm cylindrical tip (tip 600 μm, 45 millijoule /pulse, average power 2.25 W, frequency 50 Hz, pulse duration 60 µs, energy density 43 J/cm2, water 50%, and air 40%). The procedure was performed completely without anesthesia with the laser tip at angulation ~30° and distance of ~1 mm from the gingival tissue. The laser tip was advancing in scanning movement from in the cervical-apical direction in all pigmented areas. The following settings was used to achieve hemostasis in case of the bleeding was present (tip 600 μm, 30 millijoule /pulse, average power 1.5 W, frequency 50 Hz, pulse duration 700 µs, energy density 28.7 J/cm2, water 10%, and air 20%). |
| Diode laser 940 nm | Experimental | Device: Diode laser 940 nmGroup B was treated with diode 940 nm Laser. The procedure was performed with a pencil-sized handpiece containing a 400 µm lasing fiber (400 μm initiated tip, average power 0.8 watts, Pulsed mode, Duty cycle 20%, Pulse duration 10 μs, energy density 636.9 J/cm2 per second, no water or air). Infiltration anesthesia was injected for B group . The laser tip was placed in angle ~30° with the gingival surface. Short light paint brush strokes were used in the cervical-apical direction in all pigmented areas. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patient exhibiting physiologic pigmentation of score2 or more according to Oral pigmentation index (DOPI)
Key exclusion criteria (6 listed)
- Pathologic hyperpigmentation
- Participants with a systemic condition that could affect tissue healing (e. g., autoimmune diseases)
- Pregnancy and lactation
- History of smoking
- Previous mucogingival surgery at the region to be treated
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,Cr:YSGG laser 2780 nmThe depigmentation procedure essentially involves laser ablation of epithelial layer of buccal gingiva containing melanin pigmentation. | Device | Er,Cr:YSGG laser 2780 nm |
| Diode laser 940 nmThe depigmentation procedure essentially involves laser ablation of epithelial layer of buccal gingiva containing melanin pigmentation. | Device | Diode laser 940 nm |
Primary outcome
Oral pigmentation index (DOPI)
Time frame: Baseline
* Score 1: No clinical pigmentation (pink-colored gingiva) * Score 2: Mild clinical pigmentation (mild light brown color) * Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown color) * Score 4: Heavy clinical pigmentation (deep brown or bluish black color)
Oral pigmentation index (DOPI)
Time frame: 1 month post-operative
* Score 1: No clinical pigmentation (pink-colored gingiva) * Score 2: Mild clinical pigmentation (mild light brown color) * Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown color) * Score 4: Heavy clinical pigmentation (deep brown or bluish black color)
Oral pigmentation index (DOPI)
Time frame: 1 year follow-up
* Score 1: No clinical pigmentation (pink-colored gingiva) * Score 2: Mild clinical pigmentation (mild light brown color) * Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown color) * Score 4: Heavy clinical pigmentation (deep brown or bluish black color)
Oral pigmentation index (DOPI)
Time frame: 2 years follow-up
* Score 1: No clinical pigmentation (pink-colored gingiva) * Score 2: Mild clinical pigmentation (mild light brown color) * Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown color) * Score 4: Heavy clinical pigmentation (deep brown or bluish black color)
Melanin pigmentation index:
Time frame: Baseline
* Score 0: No pigmentation * Score 1: Solitary unit(s) of pigmentation in papillary gingiva without extension between neighboring solitary units * Score 2: Formation of continuous ribbon extending from neighboring solitary units
Melanin pigmentation index:
Time frame: 1 month post-operative
* Score 0: No pigmentation * Score 1: Solitary unit(s) of pigmentation in papillary gingiva without extension between neighboring solitary units * Score 2: Formation of continuous ribbon extending from neighboring solitary units
Melanin pigmentation index:
Time frame: 1 year follow-up
* Score 0: No pigmentation * Score 1: Solitary unit(s) of pigmentation in papillary gingiva without extension between neighboring solitary units * Score 2: Formation of continuous ribbon extending from neighboring solitary units
Melanin pigmentation index:
Time frame: 2 years follow-up
* Score 0: No pigmentation * Score 1: Solitary unit(s) of pigmentation in papillary gingiva without extension between neighboring solitary units * Score 2: Formation of continuous ribbon extending from neighboring solitary units
Gingival Appearance
Time frame: 1 month
* Score 1:Pink vital appearance for the gingiva * Score 2: Pale Non-vital appearance for gingiva
4 secondary outcomes
Oral Hygiene Index
Time frame: Baseline
Oral Hygiene Index
Time frame: 1 month post-operative
Gingival Index
Time frame: Baseline
Gingival Index
Time frame: 1 month post-operative
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 23 Dec 2020.
- Results publication: PubMed 22676819Simsek Kaya G, Yapici Yavuz G, Sumbullu MA, Dayi E. A comparison of diode laser and Er:YAG lasers in the treatment of gingival melanin pigmentation. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Mar;113(3):293-9. doi: 10.1016/j.tripleo.2011.03.005. Epub 2011 Jun 12.
- Results publication: PubMed 31951510Nammour S, El Mobadder M, Namour M, Namour A, Rompen E, Maalouf E, Brugnera Junior A, Brugnera AP, Vescovi P, Zeinoun T. A Randomized Comparative Clinical Study to Evaluate the Longevity of Esthetic Results of Gingival Melanin Depigmentation Treatment Using Different Laser Wavelengths (Diode, CO2, and Er:YAG). Photobiomodul Photomed Laser Surg. 2020 Mar;38(3):167-173. doi: 10.1089/photob.2019.4672. Epub 2020 Jan 17.
- Results publication: PubMed 23003920Hegde R, Padhye A, Sumanth S, Jain AS, Thukral N. Comparison of surgical stripping; erbium-doped:yttrium, aluminum, and garnet laser; and carbon dioxide laser techniques for gingival depigmentation: a clinical and histologic study. J Periodontol. 2013 Jun;84(6):738-48. doi: 10.1902/jop.2012.120094. Epub 2012 Sep 24.
- Individual participant dataSharing planned: No. there is no plan to make individual participant data (IPD) available
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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.
Omar Hamadah, PhD study director
Damascus University
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,Cr:YSGG laser 2780 nm and Diode laser 940 nm in people with Hyperpigmentation; Melanin and Laser-Induced Hyperpigmentation, run by Academy of Laser Dentistry - Gulf Laser Chapter at 1 site in Qatar.
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 1 inclusion and 6 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 23 Dec 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 Qatar. 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?
Oral pigmentation index (DOPI) (time frame: Baseline). The study lists 9 primary outcomes in all. 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 NCT04680806, which also lists 3 linked publications.
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 23 Dec 2020.