Clinical trial NCT05930392: Comparative Evaluation of Microsurgery vs Conventional Surgical Technique of Gingival Depigmentation
Official title: Comparative Evaluation of Microsurgery vs Conventional Surgical 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. Over the decades many non-surgical as well as surgical techniques have been developed to manage the melanin induced hyper-pigmentation of gingival tissue with comparable efficacies. Till date, the most common gingival depigmentation procedure 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 conventional surgical technique.

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

OBJECTIVES:

1. 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.
2. 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 parameters such as bleeding, redness, swelling, wound healing, gingival colour, gingival morphology at baseline, within 24 hours, 1 week, 1 month and 3 months.
3. To evaluate the effect of different treatment modalities on melanocyte histopathologic count (MHC).

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 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 (conventional surgical depigmentation) technique to each patient using a radio-opaque box having 44 chits.

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.

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

STUDY DESIGN: Split-mouth Comparative Randomised Controlled Clinical Study.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Gingival index (Loe and Sillness 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 periodontal status or outcome of periodontal intervention;
5. patients with Miller Grade II /Grade III tooth mobility;
6. patients taking medications such as NSAIDS, corticosteroids, statins or calcium channel blockers, which are known to influence periodontal status;
7. pregnant or lactating women;
8. history of use of tobacco;

Primary outcomes:
measure: CLINICAL PARAMETER- Bleeding
timeFrame: 3 MONTHS
measure: CLINICAL PARAMETER- REDNESS
timeFrame: 3 MONTHS
measure: CLINICAL PARAMETER- 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
timeFrame: 3 MONTHS
measure: PERIODONTAL PARAMETERS - GINGIVAL INDEX,
timeFrame: 3 MONTHS
measure: PERIODONTAL PARAMETERS - 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 PARAMETERS - 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: POST GRADUATE INSTITUTE OF DENTAL SCIENCES,ROHTAK
name: AANCHAL SAHNI, BDS
role: PRINCIPAL_INVESTIGATOR
References: