Hyperpigmentation
Conditions
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: 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.
Interventions
PROCEDUREdepigmentation
gingival depigmentation
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
split mouth (dental arches)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical outcomes of depigmentation procedure | 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. |
| patient satisfaction | 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 |
| Percieved pain | 7 days | postoperative pain will be assessed using visual analoque scale (VAS): 1= being the least pain and 10= being the most severe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| operating time | during surgery | time taken from the beginning of the procedure to its end by stopwatch |
| Wound healing | 7 days postoperative | 1. Complete reepithelialization 2. Incomplete reepithelialization 3. ulcer 4. tissue defect or necrosis Dummet 1966 |
Countries
Egypt
Outcome results
None listed