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

Study Overview
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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: 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.

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

Conditions
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Hyperpigmentation

Intervention / Treatment
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* Procedure: depigmentation


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: split mouth (dental arches)
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

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