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

NCT ID: NCT06031116

Last Updated: 2023-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-10

Study Completion Date

2023-05-10

Brief Summary

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

Detailed Description

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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.

Conditions

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Hyperpigmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

split mouth (dental arches)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ceramic soft tissue bur

Eight dental arches were treated by ceramic soft tissue bur

Group Type EXPERIMENTAL

depigmentation

Intervention Type PROCEDURE

gingival depigmentation

scalpel

Eight dental arches were treated by conventional scalpel technique

Group Type ACTIVE_COMPARATOR

depigmentation

Intervention Type PROCEDURE

gingival depigmentation

Interventions

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depigmentation

gingival depigmentation

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Sally Nassar

Dentist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasmine El sayed, Phd

Role: STUDY_DIRECTOR

Ain Shams University

Hala Abu elela, Phd

Role: STUDY_CHAIR

Ain Shams University

Sally Nassar, Bds

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Ainshams university

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ceramic v blade depigmentation

Identifier Type: -

Identifier Source: org_study_id

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