An interventional study of Diode laser and Scalpel No 15 in Melanin Hyperpigmentation, sponsored by Thamar University. Completed at 1 site in Yemen. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Thamar University · Not applicable, Interventional, and Treatment
This study aimed to compare melanin pigmentation recurrence, pain perception and wound healing between laser and scalpel surgeries in thin and thick gingival phenotypes.Thirty patients (60 sites) were included in this study. They had bilateral physiologic melanin hyperpigmentation in the upper anterior segment with severe grade II melanin hyperpigmentation. The patients were divided into two groups: each with fifteen patients with severe grade II melanin pigmentation, one with thin gingiva and another with thick gingiva. Melanin depigmentation was done in one side using scalpel no. 15 and other side with diode laser.
Background: Removal of unsightly pigmented gingiva is the need for a pleasant and confident smile. Many studies were done to study the melanin recurrence in both surgical and laser melanin depigmentation. To best of our knowledge, there is no published article regarding comparison of melanin recurrence between both techniques taking in consideration the gingival phenotype. So this study aimed to compare melanin pigmentation recurrence, pain perception and wound healing between laser and scalpel surgeries in thin and thick gingival phenotypes.
Methods: Thirty patients (60 sites) were included in this study. They had bilateral physiologic melanin hyperpigmentation in the upper anterior segment with severe grade II melanin hyperpigmentation. The patients were divided into two groups: each with fifteen patients with severe grade II melanin pigmentation, one with thin gingiva and another with thick gingiva. Melanin depigmentation was done in one side using scalpel no. 15 and other side with diode laser.
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This study's enrollment of 30 is below the median of 36 across 265 interventional studies indexed under Vitiligo.
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(i) Be aged at least 20 years, (ii) had bilateral physiologic melanin hyperpigmentation of gingiva (dark gums) in the anterior segment with severe grade II melanin hyperpigmentation (according to modification of melanin index categories 1977), (iii) periodontally healthy with good oral hygiene, (iv) had esthetic concern, (v) systemically healthy, (vi) no dental crowding and (vii) those willing to undergo minor surgical procedures.
Exclusion Criteria:
(i) any systemic disease associated with pathological hyperpigmentation), (ii) non-treated periodontal disease, (iii) chronic smokers, (iv) subjects with a mouth breathing habit (ii) subjects with crown restorations or fillings involving the incisal edge on anterior maxillary teeth, (v) non-compliant patients (vi) missing any of the six maxillary anterior teeth and having Millers Class III or Class IV recession (vii) pregnant or lactating females and (viii) (ix) gingival pigmentation of , melanoid, melanoma and carotene , (x) Gingival pigmentation adjacent to amalgam restoration, and (xi) Long-term usage of antimalarial drugs and minocycline.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Thin gingival phenotypes are delicate, highly scalloped and translucent in appearance (Fig. 3). The soft tissue appears delicate and friable with a minimal amount of the attached gingiva.
Device: Diode laser · Device: Scalpel No 15
. The thick biotype is dense and fibrotic with a wide zone of attachment, thus making it more resistant to recession. Thin gingival biotype is a delicate, highly scalloped soft tissue and is more prone to recession, bleeding, and inflammation.
Device: Diode laser · Device: Scalpel No 15
Diode Laser is a semiconductor device similar to a light-emitting diode in which a diode pumped directly with electrical current can create lasing conditions at the diode's junction. It is used in periodontal surgery as melanin depigmentation
The No.15 blade has a small curved cutting edge and is the most popular blade shape ideal for making short and precise incisions.
Melanin recurrence
It is the reappearance of melanin pigmentation following a period of time after depigmentation.
Time frame: One week, three months, and six months postoperatively
Wound healing
Wound healing was evaluated as per the list of clinical observations and patient responses as: Complete epithelization, incomplete epithelization, ulcer or tissue defect or necrosis.
Time frame: One week and one month after surgery.
Pain perception (VAS)
Pain perception via the Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be' (Fig. 1) \[1\]. The patient is asked to mark his pain level on the line between the two endpoints.
Time frame: Immediately after surgery, one day, one week and one month postoperatively
Plan to share: Undecided — Because I do not understand exactly what do you mean by sharing individual participant data (IPD)
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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