None listed
Conditions
Brief summary
This split-mouth randomized clinical trial was conducted from January 2025 to August 2025 in patient visiting Department of Periodontology and Oral Implantology after obtaining informed written consent. Total 20 patients was included in the study (split mouth design 20 in each side). Two surgical procedure namely scalpel method and ceramic soft tissue trimming bur technique for gingival depigmentation was used. Study site (for split methods) was determined based on computer generated random number and each will be assigned. After surgical procedures level of pain will be assessed with the help of visual analog scale and was filled after 1 day, 2 days and 7days. Recurrence of gingival pigmentation was assessed at the interval of baseline, 1 month, 3 months and 6 months. Patient satisfaction score was calculated at the interval of baseline, 1 month, 3 months and 6 months. Then data was collected, entered into the Microsoft excel and further analysis will be done in SPSS version 20.
Interventions
Gingival depigmentation using ceramic soft tissue trimming bur group
Gingival depigmentation will be done with ceramic soft tissue trimming bur using airoter. It is a rotary tool used to cut and reshape the soft tissue. It is attached with airoter handpeice. For depigmentation procedure, after giving local anesthesia rotating bur was moved over the pigmented gingival tissue. Intermittent irrigation will be done with saline. After complete removal of pigmented epithelium periodontal pack will be
Gingival depigmentation using ceramic soft tissue trimming bur group Gingival depigmentation will be done with ceramic soft tissue trimming bur using airoter. It is a rotary tool used to cut and reshape the soft tissue. It is attached with airoter handpeice. For depigmentation procedure, after giving local anesthesia rotating bur was moved over the pigmented gingival tissue. Intermittent irrigation will be done with saline. After complete removal of pigmented epithelium periodontal pack will be given. Analgesics will be prescribed. Total procedure time is upto 1 hour. Follow-up will be done after 1-month and 3 months and 6 months of procedure. All the procedures were done by the periodontist. All the finding will be recorded on well structured proforma by the periodontist.
Sponsors
University Grant Commission, Nepal
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
1. Systemically healthy patients who had gingival hyperpigmentation related to the aesthetic region 2. Good oral hygiene, and 3. A desire for aesthetic improvement
Exclusion criteria
1. Patients who were smokers 2. Pregnant or lactating women 3. Experienced keloid scarring following surgery 4. Patients whose gingival hyperpigmentation was linked to another syndrome or illness
Outcome results
None listed