Efficacy of Ceramic Soft Tissue Trimming Bur Versus Conventional Scalpel Technique in Ginigival Depigmentation Procedure
1 other identifier
interventional
8
1 country
1
Brief Summary
the investigator compares the clinical outcomes and pain levels after gingival depigmentation by ceramic soft tissue bur vs scalpel surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2022
CompletedFirst Submitted
Initial submission to the registry
December 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2023
CompletedFirst Posted
Study publicly available on registry
September 11, 2023
CompletedSeptember 11, 2023
September 1, 2023
6 months
December 19, 2022
September 8, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
operating time
during surgery
Wound healing
7 days postoperative
Study Arms (2)
ceramic soft tissue bur
EXPERIMENTALEight dental arches were treated by ceramic soft tissue bur
scalpel
ACTIVE COMPARATOREight dental arches were treated by conventional scalpel technique
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ainshams university
Cairo, Cairo Governorate, 11671, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yasmine El sayed, Phd
Ain Shams University
- STUDY CHAIR
Hala Abu elela, Phd
Ain Shams University
- PRINCIPAL INVESTIGATOR
Sally Nassar, Bds
Ain Shams University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dentist
Study Record Dates
First Submitted
December 19, 2022
First Posted
September 11, 2023
Study Start
October 10, 2022
Primary Completion
April 10, 2023
Study Completion
May 10, 2023
Last Updated
September 11, 2023
Record last verified: 2023-09