Laser-induced HypopigmentationPhase 1NCT02143375
Gingival Depigmentation by Diode Laser
A Phase 1 study testing 810 Diode Laser in people with Laser-induced Hypopigmentation, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Physiologic gingival pigmentation(PGP) is the most common type of gingival pigmentation and cosmetic concern particularly in gummy smile patients. Laser therapy is an effective and noninvasive treatment option. The aim of this study was to evaluate the efficacy of diod laser on the treatment of PGP in patients. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Laser-induced Hypopigmentation
- What is being tested?
- 810 Diode Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteIran
- Study dates
- Apr 2013to Mar 2014
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 19 adult patients who had been referred to oral medicine department of Shahid Beheshti dental school with the chief complaint of melanin pigmentation were selected for inclusion in this study.
Who cannot join
- Hyperpigmentation that was associated with systemic disease or drug administration,disease that could compromise wound healing (uncontrolled diabetes, autoimmune disease)
- Pregnancy or lactation
- Evidence of relationship between hyperpigmentation and malignancy
- History of previous treatment of hyperpigmentation
- Smoking
- Periodontal problems
Trial locations and contacts
1 site in 1 country.
Iran1 site
Shahid Beheshti medical university,Dental Faculty
Tehran, Tehran Province, +98
About this study
Official title: Efficacy of810 nm Diode Laser on Gingival Pigmentation
Physiologic gingival pigmentation(PGP) is the most common type of gingival pigmentation and cosmetic concern particularly in gummy smile patients. Laser therapy is an effective and noninvasive treatment option. The aim of this study was to evaluate the efficacy of diod laser on the treatment of PGP in patients.
Read the detailed description
Preoperative and postoperative photographic and clinical observations about the gingival melanin pigmentation were made according to Dummett-Gupta Oral Pigmentation Index scoring criteria given by Dummett C.O. in 1964 The investigators classified pigmented gingiva in patients as:
- Mild:Pink to slightly brown
- Moderate:Deep brown or black
- Severe:Mixed in color Score in each tooth was taken including one full inter dental papilla. Observations were made in natural light. The assessment of the scoring of the pigmentation index were done by all the three examiners, and the agreed upon score was assigned to prevent individual variations.
The investigators compared the intensity of pigmentation in each patient in recall sessions after 1month and 3mounth postoperative.
- Conditions
- Laser-induced Hypopigmentation
- Being tested
- 810 Diode Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
810 Diode LaserDevice
The 810-nm diode laser has energy and wavelength characteristics that specially target the soft tissues. It has an affinity for hemoglobin and melanin, so it is an excellent soft tissue laser and is applicated for cutting and coagulating gingival tissue.Today,sparse studies have been published assessing physiologic gingival pigmentation using diode laser,therefore the aim of this study was to evaluate the effect of diode laser on the treatment of gingival pigmentation in adult patients.
| Study group | Role | What they receive |
|---|---|---|
| 810 Diode Laser | Experimental | 810 nm Diode Laser, contact, continuous wave,320micron, Receives: Device: 810 Diode Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of gingival pigmentation
standard digital photographs were taken preoperative,1 month after laser therapy.
Measured: 1 month
Secondary outcomes (1)
changes in pigmentation based on standard digital photographs and index of Dummett et al.
standard digital photographs were taken 3 months postoperative.
Measured: 3month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startApr 2013
- Primary completionJan 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laser-induced HypopigmentationStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Somayyeh Babaei, Shahid Beheshti University of Medical Sciences
- Investigators
- Mahin Bakhshi, DDS.MS, Study chair, Associate Professor of Oral Medicine Department ,Shahid Beheshti Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143375
- Sponsor's protocol ID
- mbakhshi
- Status last verified
- Apr 2013
- First submitted
- 28 Apr 2014
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of810 nm Diode Laser on Gingival Pigmentation
- ClinicalTrials.gov ID
- NCT02143375
- Acronym / sponsor ID
- mbakhshi
- Conditions
- Laser-induced Hypopigmentation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 21 May 2014 (estimated)
- 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.
Physiologic gingival pigmentation(PGP) is the most common type of gingival pigmentation and cosmetic concern particularly in gummy smile patients. Laser therapy is an effective and noninvasive treatment option. The aim of this study was to evaluate the efficacy of diod laser on the treatment of PGP in patients.
Detailed description
Preoperative and postoperative photographic and clinical observations about the gingival melanin pigmentation were made according to Dummett-Gupta Oral Pigmentation Index scoring criteria given by Dummett C.O. in 1964 The investigators classified pigmented gingiva in patients as:
- Mild:Pink to slightly brown
- Moderate:Deep brown or black
- Severe:Mixed in color Score in each tooth was taken including one full inter dental papilla. Observations were made in natural light. The assessment of the scoring of the pigmentation index were done by all the three examiners, and the agreed upon score was assigned to prevent individual variations.
The investigators compared the intensity of pigmentation in each patient in recall sessions after 1month and 3mounth postoperative.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 810 Diode Laser | Experimental | Device: 810 Diode Laser810 nm Diode Laser, contact, continuous wave,320micron, |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 19 adult patients who had been referred to oral medicine department of Shahid Beheshti dental school with the chief complaint of melanin pigmentation were selected for inclusion in this study.
Key exclusion criteria (6 listed)
- Hyperpigmentation that was associated with systemic disease or drug administration,disease that could compromise wound healing (uncontrolled diabetes, autoimmune disease)
- Pregnancy or lactation
- Evidence of relationship between hyperpigmentation and malignancy
- History of previous treatment of hyperpigmentation
- Smoking
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 |
|---|---|---|
| 810 Diode LaserThe 810-nm diode laser has energy and wavelength characteristics that specially target the soft tissues. It has an affinity for hemoglobin and melanin, so it is an excellent soft tissue laser and is applicated for cutting and coagulating gingival tissue.Today,sparse studies have been published assessing physiologic gingival pigmentation using diode laser,therefore the aim of this study was to evaluate the effect of diode laser on the treatment of gingival pigmentation in adult patients. | Device | 810 Diode Laser |
Primary outcome
improvement of gingival pigmentation
Time frame: 1 month
standard digital photographs were taken preoperative,1 month after laser therapy.
1 secondary outcome
changes in pigmentation based on standard digital photographs and index of Dummett et al.
Time frame: 3month
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 21 May 2014.
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.
Mahin Bakhshi, DDS.MS study chair
Associate Professor of Oral Medicine Department ,Shahid Beheshti Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 810 Diode Laser in people with Laser-induced Hypopigmentation, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 21 May 2014. 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 Iran. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
improvement of gingival pigmentation (time frame: 1 month). 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 21 May 2014.