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

Primary Purpose

Hyperpigmentation

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

depigmentation

About this trial

This is an interventional treatment trial for Hyperpigmentation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Ainshams university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ceramic soft tissue bur

scalpel

Arm Description

Eight dental arches were treated by ceramic soft tissue bur

Eight dental arches were treated by conventional scalpel technique

Outcomes

Primary Outcome Measures

clinical outcomes of depigmentation procedure

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.

patient satisfaction

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

Percieved pain

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

Secondary Outcome Measures

operating time

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

Wound healing

Complete reepithelialization Incomplete reepithelialization ulcer tissue defect or necrosis Dummet 1966

Full Information

NCT ID

NCT06031116

First Posted

December 19, 2022

Last Updated

September 8, 2023

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT06031116

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

October 10, 2022 (Actual)

Primary Completion Date

April 10, 2023 (Actual)

Study Completion Date

May 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperpigmentation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

split mouth (dental arches)

Masking

Participant

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ceramic soft tissue bur

Arm Type

Experimental

Arm Description

Eight dental arches were treated by ceramic soft tissue bur

Arm Title

scalpel

Arm Type

Active Comparator

Arm Description

Eight dental arches were treated by conventional scalpel technique

Intervention Type

Procedure

Intervention Name(s)

depigmentation

Intervention Description

gingival depigmentation

Primary Outcome Measure Information:

Title

clinical outcomes of depigmentation procedure

Description

Time Frame

3 month postoperative

Title

patient satisfaction

Description

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

Time Frame

3 months postoperative

Title

Percieved pain

Description

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

Time Frame

7 days

Secondary Outcome Measure Information:

Title

operating time

Description

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

Time Frame

during surgery

Title

Wound healing

Description

Complete reepithelialization Incomplete reepithelialization ulcer tissue defect or necrosis Dummet 1966

Time Frame

7 days postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yasmine El sayed, Phd

Organizational Affiliation

Ain Shams University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Hala Abu elela, Phd

Organizational Affiliation

Ain Shams University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Sally Nassar, Bds

Organizational Affiliation

Ain Shams University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ainshams university

City

Cairo

State/Province

القاهرة

ZIP/Postal Code

11671

Country

Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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