Gingival PigmentationNCT06167148
Gingival Depigmentation Using Diode Laser 940nm Versus 980nm
A study testing Biolase Epic X 940nm wavelength Diode laser and Doctor smile simpler 980nm wavelength Diode laser in people with Gingival Pigmentation, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
is study aimed to evaluate the effectiveness of two diode lasers of different wave lengths 940nm and 980nm for the treatment of physiologic gingival melanin hyperpigmentation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gingival Pigmentation
- What is being tested?
- Biolase Epic X 940nm wavelength Diode laser and Doctor smile simpler 980nm wavelength Diode laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 22 Nov 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of both sexes diagnosed clinically with physiologic gingival pigmentation.
- Pigmentation extending from canine to canine in either upper or lower arch.
Who cannot join
- Smokers.
- Patients with uncontrolled metabolic disease.
- Immuno-compromised patients.
- Patients with renal disease.
- Patients having coagulation disorders.
- Pregnant and lactating women.
- Evidence about the relation of pigmentation with malignancies.
- History of previous treatment of gingival pigmentation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gingival Depigmentation Using Diode Laser 940nm Versus 980nm: A Split-mouth Comparative Clinical Trial
is study aimed to evaluate the effectiveness of two diode lasers of different wave lengths 940nm and 980nm for the treatment of physiologic gingival melanin hyperpigmentation.
- Conditions
- Gingival Pigmentation
- Being tested
- Biolase Epic X 940nm wavelength Diode laser, Doctor smile simpler 980nm wavelength Diode laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biolase Epic X 940nm wavelength Diode laserDevice
Participants were treated with Biolase Epic X 940nm wavelength Diode laser set at a power of 1 W, fiber 400 µ, irradiation mode: pulsed wave (P3).
Doctor smile simpler 980nm wavelength Diode laserDevice
Participants were treated with doctor smile simpler 980nm wavelength Diode laser set at a power of 1 W, fiber 400 µ, irradiation mode: pulsed wave (SP).
| Study group | Role | What they receive |
|---|---|---|
| 940nm wavelength Diode laser | Experimental | Not described Receives: Device: Biolase Epic X 940nm wavelength Diode laser |
| 980nm wavelength Diode laser | Active comparator | Not described Receives: Device: Doctor smile simpler 980nm wavelength Diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pigmentation
Intensity of pigmentation was assessed with Dummett Oral Pigmentation Index (DOPI 1971).
DOPI was scored as:
Score 1: No clinical pigmentation (pink gingiva) Score 2: Mild clinical pigmentation (mild light brown color) Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown) Score 4: Heavy clinical pigmentation (deep brown or bluish black).
Measured: up to 12 weeks
Extension of pigmentation
Extension of pigmented area was assessed by, Hedin Melanin Index (HMI).
It was scored as:
Degree 1: Isolated-only 1 or 2 pigmented interdental papillae Degree 2: Numerous pigmented interdental papillae Degree 3: Short continuous ribbons Degree 4: Long continuous ribbon
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Oct 2021
- Primary completion20 Nov 2023
- Study completion22 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival PigmentationStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Souzy K Anwar, PhD, Principal investigator, Alexandria UniversityYasmine Y Gaweesh, PhD, Study director, Alexandria UniversityNourhan M Aly, MSc, Study director, Alexandria UniversityGillan I El-Kimary, PhD, Study chair, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167148
- Sponsor's protocol ID
- 5/23
- Status last verified
- Dec 2023
- First submitted
- 3 Dec 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Depigmentation Using Diode Laser 940nm Versus 980nm: A Split-mouth Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT06167148
- Acronym / sponsor ID
- 5/23
- Conditions
- Gingival Pigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 12 Dec 2023 (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.
is study aimed to evaluate the effectiveness of two diode lasers of different wave lengths 940nm and 980nm for the treatment of physiologic gingival melanin hyperpigmentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 940nm wavelength Diode laser | Experimental | Device: Biolase Epic X 940nm wavelength Diode laser |
| 980nm wavelength Diode laser | Active comparator | Device: Doctor smile simpler 980nm wavelength Diode laser |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of both sexes diagnosed clinically with physiologic gingival pigmentation.
- Pigmentation extending from canine to canine in either upper or lower arch.
Key exclusion criteria (8 listed)
- Smokers.
- Patients with uncontrolled metabolic disease.
- Immuno-compromised patients.
- Patients with renal disease.
- Patients having coagulation disorders.
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 |
|---|---|---|
| Biolase Epic X 940nm wavelength Diode laserParticipants were treated with Biolase Epic X 940nm wavelength Diode laser set at a power of 1 W, fiber 400 µ, irradiation mode: pulsed wave (P3). | Device | 940nm wavelength Diode laser |
| Doctor smile simpler 980nm wavelength Diode laserParticipants were treated with doctor smile simpler 980nm wavelength Diode laser set at a power of 1 W, fiber 400 µ, irradiation mode: pulsed wave (SP). | Device | 980nm wavelength Diode laser |
Primary outcome
Intensity of pigmentation
Time frame: up to 12 weeks
Intensity of pigmentation was assessed with Dummett Oral Pigmentation Index (DOPI 1971). DOPI was scored as: Score 1: No clinical pigmentation (pink gingiva) Score 2: Mild clinical pigmentation (mild light brown color) Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown) Score 4: Heavy clinical pigmentation (deep brown or bluish black).
Extension of pigmentation
Time frame: up to 12 weeks
Extension of pigmented area was assessed by, Hedin Melanin Index (HMI). It was scored as: Degree 1: Isolated-only 1 or 2 pigmented interdental papillae Degree 2: Numerous pigmented interdental papillae Degree 3: Short continuous ribbons Degree 4: Long continuous ribbon
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 12 Dec 2023.
Related trials for Gingival Pigmentation
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Influence of Adjunctive Acids Use on Esthetic Outcomes of Gingival Melanin Depigmentation: A Periodontal-Operative Pilot Randomized Clinical Trial
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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.
Souzy K Anwar, PhD principal investigator
Alexandria University
Yasmine Y Gaweesh, PhD study director
Alexandria University
Nourhan M Aly, MSc study director
Alexandria 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 Biolase Epic X 940nm wavelength Diode laser and Doctor smile simpler 980nm wavelength Diode laser in people with Gingival Pigmentation, run by Nourhan M.Aly at 1 site in Egypt.
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 8 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 12 Dec 2023. 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 Egypt. 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?
Intensity of pigmentation (time frame: up to 12 weeks). 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 12 Dec 2023.