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

Hyperpigmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06031116
• Other study ID #: ceramic v blade depigmentation
• Status: Completed
• Phase: N/A
• Start date: October 10, 2022
• Est. completion date: May 10, 2023

Study information

• Verified date: September 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 10, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperpigmentation
• Hypopigmentation

Intervention

Procedure:
• depigmentation
gingival depigmentation

Locations

Country	Name	City	State
Egypt	Ainshams university	Cairo	???????

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 month postoperative
Primary	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	3 months postoperative
Primary	Percieved pain	postoperative pain will be assessed using visual analoque scale (VAS): 1= being the least pain and 10= being the most severe	7 days
Secondary	operating time	time taken from the beginning of the procedure to its end by stopwatch	during surgery
Secondary	Wound healing	Complete reepithelialization; Incomplete reepithelialization; ulcer; tissue defect or necrosis Dummet 1966	7 days postoperative