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OpenTrials
Completed

NCT Number: NCT06031116

Efficacy of Ceramic Soft Tissue Trimming Bur Versus Conventional Scalpel Technique in Ginigival Depigmentation Procedure

the investigator compares the clinical outcomes and pain levels after gingival depigmentation by ceramic soft tissue bur vs scalpel surgery

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Key information

Conditions

Hyperpigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ainshams university

Cairo, Cairo Governorate, 11671, Egypt

About this study

This clinical study will be carried out to compare the efficacy of ceramic soft tissue trimming bur versus the conventional surgical scraping technique in the management of gingival hyperpigmentation.

This study will be conducted to assess:

Primary objectives:

  • Clinical outcome of the gingival depigmentation procedure.
  • Assessment of postoperative pain using the visual analogue scale.
  • Patients' satisfaction will be assessed using the patient satisfaction questionnaire (short-form, PSQ-18) and the global aesthetic improvement scale.

Secondary objectives:

  • Operating time.
  • Wound healing.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females within age range of 20-50 years.
  • Systemic (medically) free individuals.
  • Gingival pigmentation score > 3 on Hedin melanin index15.
  • Patients with good oral hygiene.
  • Patients with thick gingival phenotype.

Exclusion criteria

  • Smokers.
  • Teeth with compromised periodontium.
  • Pregnant and lactating females.
  • The vulnerable group: patients with mental or physical disabilities.
  • Medications that cause gingival pigmentation.
  • Pathologies that cause gingival pigmentation.

Treatment and study plan

depigmentation

Procedure

gingival depigmentation

Primary outcomes

  1. clinical outcomes of depigmentation procedure

    Time frame: 3 month postoperative

    dummet oral pigmentation index ( DOPI): 1= pink no pigmentation (better) 4= deep brown (worse) Melanin index (MI):1= isolated pigment (better), 4= long continous ribbon (worse). reported by visual inspection.

  2. patient satisfaction

    Time frame: 3 months postoperative

    global aesthetic improvement scale 5 point likert scale 1= excellent improvement 5= worsened. patient reported outcome.

    a score from 1 to 5, 1 being better

  3. Percieved pain

    Time frame: 7 days

    postoperative pain will be assessed using visual analoque scale (VAS): 1= being the least pain and 10= being the most severe

Secondary outcomes

  1. operating time

    Time frame: during surgery

    time taken from the beginning of the procedure to its end by stopwatch

  2. Wound healing

    Time frame: 7 days postoperative

    • Complete reepithelialization
    • Incomplete reepithelialization
    • ulcer
    • tissue defect or necrosis Dummet 1966

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 11, 2023
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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