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

September 8, 2023 updated by: Sally Nassar, Ain Shams University
the investigator compares the clinical outcomes and pain levels after gingival depigmentation by ceramic soft tissue bur vs scalpel surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • القاهرة
      • Cairo, القاهرة, Egypt, 11671
        • AinShams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ceramic soft tissue bur
Eight dental arches were treated by ceramic soft tissue bur
Procedure: depigmentation
gingival depigmentation
Active Comparator: scalpel
Eight dental arches were treated by conventional scalpel technique
Procedure: depigmentation
gingival depigmentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 month postoperative
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 months postoperative
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
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operating time
Time Frame: during surgery
time taken from the beginning of the procedure to its end by stopwatch
during surgery
Wound healing
Time Frame: 7 days postoperative
  1. Complete reepithelialization
  2. Incomplete reepithelialization
  3. ulcer
  4. tissue defect or necrosis Dummet 1966
7 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Yasmine El sayed, Phd, Ain Shams University
  • Study Chair: Hala Abu elela, Phd, Ain Shams University
  • Principal Investigator: Sally Nassar, Bds, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2022

Primary Completion (Actual)

April 10, 2023

Study Completion (Actual)

May 10, 2023

Study Registration Dates

First Submitted

December 19, 2022

First Submitted That Met QC Criteria

September 8, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ceramic v blade depigmentation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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