Comparative Evaluation of Microsurgery vs Conventional Surgical Technique of Gingival Depigmentation

NCT ID: NCT05930392

Last Updated: 2023-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2023-10-10

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.

Conditions

Gingival Pigmentation; Melanosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

GINGIVAL DEPIGMENTATION USING MICROSURGERY

Surgical excision of hyper-pigmented gingival tissue using microsurgical blade (keratome 2.2) and magnification loupes under local anaesthesia. Application of periodontal dressing followed by post-operative instructions.

Group Type: ACTIVE_COMPARATOR

Gingival depigmentation using microsurgery

Intervention Type: PROCEDURE

GINGIVAL DEPIGMENTATION USING MICROSURGICAL BLADE AND MAGNIFICATION LOUPES

Conventional surgical technique of gingival depigmentation

Surgical excision of hyper-pigmented gingival tissue using conventional surgical blade (#15) under local anaesthesia. Application of periodontal dressing followed by post-operative instructions.

Group Type: ACTIVE_COMPARATOR

Conventional surgical depigmentation

Intervention Type: PROCEDURE

GINGIVAL DEPIGMENTATION USING CONVENTIONAL SURGICAL TECHNIQUE

Interventions

Gingival depigmentation using microsurgery

GINGIVAL DEPIGMENTATION USING MICROSURGICAL BLADE AND MAGNIFICATION LOUPES

Intervention Type: PROCEDURE

Conventional surgical depigmentation

GINGIVAL DEPIGMENTATION USING CONVENTIONAL SURGICAL TECHNIQUE

Intervention Type: PROCEDURE

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;

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AANCHAL SAHNI, BDS

Role: PRINCIPAL_INVESTIGATOR

POST GRADUATE INSTITUTE OF DENTAL SCIENCES,ROHTAK

Locations

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, India

Countries

India

Central Contacts

RAJINDER KR SHARMA, MDS

Role: CONTACT

rksharmamds@yahoo.in

9416358222

Facility Contacts

RAJINDER KR SHARMA, MDS

Role: primary

rksharmamds@yahoo.in

9416358222

Other Identifiers

AANCHALSAHNIPERIO2

Identifier Type: -

Identifier Source: org_study_id