Post Gingival Depigmentation Assessment: Comparison of Surgical Stripping vs (Er,Cr:YSGG) Laser

NCT06075641 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-10-10

No results posted yet for this study

Summary

The appearance and health of the gingiva significantly contribute to an aesthetically pleasing smile. Pink gingiva indicates healthy gums and is generally preferred over dark or mixed colors. However, gingival color varies among individuals based on factors such as race, geography, gum health, epithelial thickness, vascular supply, keratinization level, and pigments in the epithelium layers.

Four primary pigments define mucosa color: melanin, oxygenated hemoglobin (Hb), carotenoids, and reduced Hb. Melanin notably affects excessive gingival pigmentation. Gingival melanin hyperpigmentation, sometimes called racial pigmentation, is a genetic trait present in many ethnic groups due to excess melanin deposition in the epithelial layers. While not a medical concern, this hyperpigmentation can be unattractive, especially for those with a gummy smile. As a result, many seek treatments to reduce or eliminate this pigmentation.

Various methods for gingival depigmentation exist, including surgical scraping, scalpel technique, bur abrasion, free gingival graft, gingivectomy, cryosurgery, electrosurgery, chemical treatments, and lasers. A significant challenge with these treatments is gingival repigmentation or the reappearance of melanin post-procedure.

For years, the scalpel technique was the standard. It's a straightforward and economical method that involves removing the gingival epithelium and some underlying tissue. Although it promotes quick healing, the procedure can cause bleeding, necessitating local anesthesia and post-operative dressings. Due to the associated discomfort, researchers have sought equally effective alternatives.

Laser ablation has become a popular choice among dental professionals and patients. Lasers like carbon dioxide (CO2), diode, argon, ruby, Nd:YAG (neodymium-doped yttrium aluminum garnet) , and Er:YAG (erbium-doped yttrium aluminium garnet) have been proven effective through numerous studies. Lasers present benefits such as minimal post-operative pain, ease of use, and quicker treatment times. Recurrence rates post-laser surgery (1.16%) are lower than with the scalpel technique (4.25%). However, lasers also have downsides, including high costs, potential for thermal damage, and the risk of deep penetration.

One laser, the Erbium-chromium:yttrium-scandium-gallium-garnet (Er,Cr:YSGG), has been FDA-approved for certain dental procedures but hasn't been widely used for gingival depigmentation. Preliminary findings suggest it offers advantages like reduced pain and faster healing compared to other lasers. In a case study involving two patients, the Er,Cr:YSGG laser effectively removed gingival pigmentation, with no recurrence observed after six months.

This clinical trial aimed to compare the efficacy and recurrence rates between the conventional scalpel technique and the Er,Cr:YSGG laser technique. The hypothesis suggests that the Er,Cr:YSGG laser might be a superior treatment for gingival hyperpigmentation compared to other methods.

Conditions

  • Pigmentation
  • Gingiva

Interventions

PROCEDURE

Gingival depigmentation

Gingival depigmentation is the most widely used periodontal procedure to remove or reduce the melanotic areas. Various techniques can be employed to effectively carry out the depigmentation procedure, including surgical scraping, scalpel technique, bur abrasion, free gingival graft, gingivectomy, cryosurgery, electrosurgery, chemical therapies, and different types of lasers

Sponsors & Collaborators

  • King Abdulaziz University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2021-01-01
Completion
2021-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06075641 on ClinicalTrials.gov