Clinical trial NCT05930366: Comparative Evaluation of Microsurgery vs Diode Laser Technique of Gingival Depigmentation
Official title: Comparative Evaluation of Microsurgery vs Diode Laser Technique of Gingival Depigmentation on Pink Esthetics and Patient-related Outcomes: A Split-mouth Randomised Controlled Clinical Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Pigmentation
Melanosis
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gingiva being the most frequently pigmented tissue of the oral cavity challenges a lot of people with an esthetic concern. Increased production of melanin, a pigment produced by the melanocytes present in the basal and suprabasal cell layers of the epithelium leads to the hyper-pigmented appearance of these tissues. Over the decades many non-surgical as well as surgical techniques have been developed to remove the melanin induced hyper-pigmentation of gingival tissue with comparable efficacies. The surgical treatment modalities include use of scalpel, laser ablation, bur abrasion, electrocautery, cryosurgery, radio-surgery, free gingival grafts and acellular dermal matrix allograft etc. Diode lasers have frequently been used in a variety of soft tissue surgical procedures and have many advantages such as less pain, bleeding, scar formation and infection. Examined histologically, laser wounds have been resulted in less wound contracture or scarring, and ultimately improved healing. Depigmentation with lasers has become popular in recent times due to good results but requires sophisticated equipment and occupies a large space. Therefore the most practical gingival depigmentation procedure, both patient and operator wise, with satisfactory results remains the conventional scalpel (#15 blade) method. Nowadays, minimally traumatising the surgical field and gaining maximum outputs with help of microscopy and microsurgical instruments has attained a level of utmost importance in surgical procedures including periodontal therapy. Improved results in terms of increased vascularization of the grafts, relatively better percentages of root coverage a significant increase in width and thickness of keratinized tissue, an improved esthetic outcome and decreased patient morbidity in cases of gingival recession treated via microsurgical approach have been observed and well documented. However, perusal of the literature available suggests that clinical outcomes and esthetic potential of the results of gingival depigmentation using principles of microsurgery is an area of interest that still needs to be explored further. This study is therefore aimed at evaluating and comparing the clinical, esthetic and patient-related outcomes of gingival depigmentation performed using microsurgery vs diode laser technique.

Detailed description: AIM: To evaluate and compare the clinical, esthetic and patient-related outcomes of gingival depigmentation performed via Microsurgery vs Diode Laser technique.

OBJECTIVES:

To evaluate and compare melanin pigmentation using Dummett Oral Pigmentation Index (DOPI), Hedin melanin index (HMI) between both the treatment modalities at baseline, 1 week, 1 month and 3 months post-operatively.

To assess a) patient-related outcome measures (PROMs) such as post-operative pain perception/discomfort on a visual analog scale (VAS) , patient's preference of the mode of treatment /esthetic satisfaction and b) clinical parameters13 such as bleeding, redness, swelling, wound healing, gingival colour, gingival morphology at baseline, within 24 hours, 1 week, 1 month and 3 months.

To evaluate the effect of different treatment modalities on melanocyte histopathologic count (MHC).

SETTING: Department of Periodontology and Oral Implantology, PGIDS, Rohtak, Haryana.

STUDY DESIGN: Split-mouth Comparative Randomised Controlled Clinical Study. TIME FRAME: 3 months SAMPLE SIZE: To achieve a power of 80%, level of significance of 5% and assuming an effect size of 0.8, a minimum sample size of 18 patients is needed in each group. Accounting for a 20% drop out rate, 22 patients are needed in each group.

METHODOLOGY: Patients with a chief complaint of unpleasant appearance of gingival tissue will be recruited from the outpatient Department of Periodontology, PGIDS, Rohtak. Patients fulfilling the eligibility criteria will be enrolled in the study after obtaining an informed written consent. A split-mouth design with maxillary and mandibular anteriors being randomly allocated into test (Microsurgery) and control (Diode laser technique) group to each patient using a chit method.

STATISTICAL ANALYSIS: Data recorded will be processed by standard statistical analysis. The normality of distribution of data will be examined by Shapiro Wilk test. Statistical analysis will be performed according to distribution of data. If it is in normal distribution, intra group comparison will be done by paired t-test between two time points and inter group comparison will be done by using unpaired t-test between two groups. If it is in non-normal distribution, intra group comparison will be done by Wilcoxon signed rank test and inter group comparison will be done by Mann-Whitney U test.

Eligibility criteria: INCLUSION CRITERIA:

1) Systemically healthy patients seeking treatment for gingival hyper-pigmentation.

EXCLUSION CRITERIA:

1. Gingival index (Leo and silliness 1963) of greater than or equal to 1 at any site of surgical field.
2. Patients with periodontitis
3. Patients with pathologic or drug-induced gingival hyper-pigmentation
4. Patients with history of systemic illness with the potential to influence the
5. Periodontal status or outcome of periodontal intervention;
6. Patients with Miller Grade II /Grade III tooth mobility;
7. Patients taking medications such as NSAIDS, corticosteroids, statins or calcium 8
8. Channel blockers, which are known to influence periodontal status;
9. Pregnant or lactating women;
10. History of use of tobacco;

Primary outcomes:
measure: CLINICAL PARAMETER- BLEEDING
timeFrame: 3 MONTHS
measure: CLINICAL PARAMETER- REDNESS
timeFrame: 3 MONTHS
measure: CLINICAL PARAMETERS- SWELLING
timeFrame: 3 MONTHS
measure: CLINICAL PARAMETER- WOUND HEALING
timeFrame: 3 MONTHS
measure: CLINICAL PARAMETER- GINGIVAL COLOR
timeFrame: 3 MONTHS
measure: DUMMETT ORAL PIGMENTATION INDEX (DOPI)
timeFrame: 3 MONTHS
measure: HEDIN MELANIN INDEX (HMI)
timeFrame: 3 MONTHS
measure: Patient-related outcome measures (PROMs) - POST-OPERATIVE PAIN PERCEPTION
timeFrame: 3 MONTHS
measure: Patient-related outcome measures (PROMs) - ESTHETIC SATISFACTION
timeFrame: 3 MONTHS
Secondary outcomes:
measure: MELANOCYTE HISTOPATHOLOGIC COUNT (MHC)
timeFrame: 3 MONTHS
measure: PERIODONTAL PARAMETER- PLAQUE INDEX (PI)
timeFrame: 3 MONTHS
measure: PERIODONTAL PARAMETER - GINGIVAL INDEX (GI)
timeFrame: 3 MONTHS
measure: PERIODONTAL PARAMETER- BLEEDING ON PROBING (BOP)
timeFrame: 3 MONTHS
measure: PERIODONTAL PARAMETER - PROBING POCKET DEPTH (PPD)
timeFrame: 3 MONTHS
measure: PERIODONTAL PARAMETER - CLINICAL ATTACHMENT LEVEL (CAL)
timeFrame: 3 MONTHS
measure: PERIODONTAL PARAMETER - GINGIVAL RECESSION (GR)
timeFrame: 3 MONTHS
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post graduate institute of dental sciences
state: Haryana
Study officials:
affiliation: PGIDS ROHTAK
name: AANCHAL SAHNI, BDS
role: PRINCIPAL_INVESTIGATOR
References: