Gingiival Hyperpigmentation
Conditions
Keywords
Microneedling, Glutathione, Depigmentation, Repigmentation
Brief summary
The colour of gingiva is important determinant of smile esthetics.Owing to increasing awareness and demand for cosmetic procedures over the past decade, gingival depigmentation has gained popularity among periodontal plastic surgical procedures.
Detailed description
various treatment modalities for depigmentation has been used over the decades. Microneedling is a minimally invasive procedure that creates micro pores on the gingiva which stimulates the natural healing process and improve penetration of topical agents.Glutathione when used has shown promising results in reducing pigmentation which is a major concern with the treatment. In this study 15 patients meeting the eligibility criteria has been randomly assigned to either of the arms.
Interventions
DEVICEMicroneedling using Dermapen device
Dermapen device that is being used for microneedling creates micro conuits because of whuch wound healing will bee improved and it helps penetration of agents effectively
OTHERMicroneedling with 0.5 % Glutathione gel
Usage of micreoneedling with topical application of 0.5% glutathione gel as an adjunct
Sponsors
Krishnadevaraya College of Dental Sciences & Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Patients between the age group of 18 to 45 years * Systemically healthy subjects * Maxillary or mandibular keratinised gingiva with minimum mean SEMPI score of 1(light grey / brown pigmentation) and above.
Exclusion criteria
* Patients with thin gingival phenotype(\<1mm) * Patients on drugs that cause oral pigmentation like antimalarials,minocycline, oral contraceptives etc., * Systemic disorders that cause oral pigmentation ,Pregnant and lactating women * Subjects with history of smoking.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Gingival pigmentation using SEMPI index | baseline, 1 month, 3 months, 6 months | Severity and Extension of Gingival Melanotic Pigmentation Index is used for assessing the gingival pigmentation |
| Assessment of pigment surface area using Image J analysis software | baseline, 1 month, 3 months, 6 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of repigmentation | 6 months | Repigmentation rate assessed using change in sempi score and pigment surface area on image J over the period |
| patient reported pain or discomfort | at the time of treatment , 1 month | using visual analog scale |
Countries
India
Outcome results
None listed