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

Sponsor
King Abdulaziz University (Other)
Overall Status
Completed
CT.gov ID
NCT06075641
Collaborator
(none)
40
2
48

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Gingival depigmentation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Surgical Stripping and Erbium, Chromium:Yttrium-scandium-gallium-garnet (Er,Cr:YSGG) Laser Techniques for Gingival Depigmentation Recurrence: A Randomized Clinical Trial, Four Years Follow up
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Jan 1, 2021
Actual Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Surgical Stripping

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

Experimental: Erbium, chromium:yttrium-scandium-gallium-garnet (Er,Cr:YSGG) Laser Techniques

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

Outcome Measures

Primary Outcome Measures

  1. Oral pigmentation index (DOPI) [Pre surgical, 1 month post op, 12 months post op]

    This index of oral pigmentation is the commonly used index due to its simplicity and ease of use. The scores are as follows: 0 = No clinical pigmentation (pink-colored gingiva) Mild clinical pigmentation (mild light brown color) Moderate clinical pigmentation (medium brown or mixed pink and brown color) Heavy clinical pigmentation (deep brown or bluish black color)

  2. Gingival melanosis record (GMR) [Pre surgical, 1 month post op, 12 months post op]

    A quantitative analysis method using clinical oral photographs

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Over 18 years of age

  • Periodontally healthy subjects with concerns about their esthetics and presence of gingival hyperpigmentation in the upper arch

Exclusion Criteria:
  • (1) smokers or were previous smokers

  • (2) had a systemic disease/condition,

  • (3) were pregnant/lactating

  • (4) had gingivitis, periodontitis or any other periodontal disease

  • (5) acquired amalgam pigmentation were excluded from the study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • King Abdulaziz University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Talal Zahid, Chairman of Periodontology Department, King Abdulaziz University
ClinicalTrials.gov Identifier:
NCT06075641
Other Study ID Numbers:
  • 077-16
First Posted:
Oct 10, 2023
Last Update Posted:
Oct 10, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Talal Zahid, Chairman of Periodontology Department, King Abdulaziz University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 10, 2023