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

A

Ain Shams University

Status

Completed

Conditions

Hyperpigmentation

Treatments

Procedure: depigmentation

Study type

Interventional

Funder types

Other

Identifiers

NCT06031116
ceramic v blade depigmentation

Details and patient eligibility

About

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

Full description

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:

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

Secondary objectives:

  1. Operating time.
  2. Wound healing.

Enrollment

8 patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

8 participants in 2 patient groups

ceramic soft tissue bur
Experimental group
Description:
Eight dental arches were treated by ceramic soft tissue bur
Treatment:
Procedure: depigmentation
scalpel
Active Comparator group
Description:
Eight dental arches were treated by conventional scalpel technique
Treatment:
Procedure: depigmentation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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