Melanin Recurrence in Scalpel and LASER Gingival Depigmentation in Thin and Thick Phenotypes.

Not Applicable

Completed

• Conditions: Melanin Hyperpigmentation

• Registration Number: NCT06886100
• Lead Sponsor: Thamar University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-03-04
• Primary Completion: 2024-12-18
• Study Completion: 2024-12-18
• Status Verified: 2025-03
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-14
• Last Update Submitted: 2025-03-14
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

(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 hemoglobin, melanoid, melanoma and carotene , (x) Gingival pigmentation adjacent to amalgam restoration, and (xi) Long-term usage of antimalarial drugs and minocycline.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Melanin recurrence	One week, three months, and six months postoperatively	It is the reappearance of melanin pigmentation following a period of time after depigmentation.

Secondary Outcome Measures

Name	Time	Method
Pain perception (VAS)	Immediately after surgery, one day, one week and one month postoperatively	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.
Wound healing	One week and one month after surgery.	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.

Trial Locations

Locations (1)

Wadhah dental center; 🇾🇪 Sanaa, Yemen