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the investigator compares the clinical outcomes and pain levels after gingival depigmentation by ceramic soft tissue bur vs scalpel surgery
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:
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ceramic soft tissue bur | Experimental | Eight dental arches were treated by ceramic soft tissue bur |
|
| scalpel | Active Comparator | Eight dental arches were treated by conventional scalpel technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| depigmentation | Procedure | gingival depigmentation |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| operating time | time taken from the beginning of the procedure to its end by stopwatch | during surgery |
| Wound healing |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yasmine El sayed, Phd | Ain Shams University | Study Director |
| Hala Abu elela, Phd | Ain Shams University | Study Chair |
| Sally Nassar, Bds | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ainshams university | Cairo | Cairo Governorate | 11671 | Egypt |
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| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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split mouth (dental arches)
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| 7 days postoperative |