Comparative Evaluation of Microsurgery vs Conventional Surgical Technique of Gingival Depigmentation

Gingival Pigmentation Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05930392
• Other study ID #: AANCHALSAHNIPERIO2
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: October 10, 2023

Study information

• Verified date: June 2023
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: RAJINDER KR SHARMA, MDS
• Phone: 9416358222
• Email: rksharmamds[@]yahoo.in
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: October 10, 2023
• Est. primary completion date: September 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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;

Related Conditions & MeSH terms

• Gingival Pigmentation
• Hypopigmentation
• Melanosis

Intervention

Procedure:
• Gingival depigmentation using microsurgery
GINGIVAL DEPIGMENTATION USING MICROSURGICAL BLADE AND MAGNIFICATION LOUPES
• Conventional surgical depigmentation
GINGIVAL DEPIGMENTATION USING CONVENTIONAL SURGICAL TECHNIQUE

Locations

Country	Name	City	State
India	Post Graduate Institute of Dental Sciences	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CLINICAL PARAMETER- Bleeding	bleeding score classified in accordance to Ishi et al and Kawashima et al; A: NONE B: SLIGHT C: MODERATE D: SEVERE	3 MONTHS
Primary	CLINICAL PARAMETER- REDNESS	redness score classified in accordance to Ishi et al and Kawashima et al; A: NONE B: SLIGHT C: MODERATE D: SEVERE	3 MONTHS
Primary	CLINICAL PARAMETER- swelling	swelling score classified in accordance to Ishi et al and Kawashima et al; A: NONE B: SLIGHT C: MODERATE D: SEVERE	3 MONTHS
Primary	CLINICAL PARAMETER- WOUND HEALING	Wound healing score classified in accordance to Ishi et al and Kawashima et al; A: COMPLETE EPITHELIALIZATION B: INCOMPLETE OR PARTIAL EPITHELIALIZATION C: ULCER D: TISSUE DEFECT OR NECROSIS	3 MONTHS
Primary	CLINICAL PARAMETER- Gingival color	Gingival Color; A: IMPROVEMENT B: SLIGHT IMPROVEMENT C: NO CHANGE D: DETERIORATION	3 MONTHS
Primary	DUMMETT ORAL PIGMENTATION INDEX (DOPI)	DOPI; Score Criteria 0 Pink tissue (no clinical pigmentation); Mild light brown tissue (mild clinical pigmentation); Medium brown or mixed brown and pink tissue (moderate clinical pigmentation); Deep brown/ blue-black tissue (heavy clinical pigmentation)	3 MONTHS
Primary	HEDIN MELANIN INDEX (HMI)	HMI; Score Criteria 0 No pigmentation; One or two solitary units of pigmentation in the papillary gingiva; >3 units of pigmen- tation in the papillary gingiva without formation of a continuous ribbon; More than equal to 1 short continuous ribbons of pigmentation; One continuous ribbon including the entire area between the canines	3 MONTHS
Primary	Patient-related outcome measures (PROMs) - post-operative pain perception	Pain will be assessed on a 100-mm horizontal, continuous interval scale with the left endpoint marked ''no pain'' and the right endpoint marked ''worst pain.'' The patient placed a mark to coincide with the level of pain. Scores were calculated as: 0 = no pain; 0.1 to 3.0 cm (1 to 30 mm) = slight pain; 3.1 to 6.0 cm (31 to 60 mm) = moderate pain; 6.1 to 10 cm (61 to 100 mm) = severe pain.	3 months
Primary	Patient-related outcome measures (PROMs) - ESTHETIC SATISFACTION	ESTHETIC SATISFACTION WILL BVE EVALUATED AS PER PATIENT'S RESPONSE TO PREFERRED CHOICE OF TREATMENT - CONVENTIONAL OR MICROSURGICAL	3 months
Secondary	MELANOCYTE HISTOPATHOLOGIC COUNT (MHC)	EFFECT ON MELANOCYTE HISTOPATHOLOGIC COUNT; The activity of the melanocytes will be measured at baseline and 3 months post-operatively, by microscopically viewing the density of melanin granules.35 The grading will be done using the following scale: 0 = absence of melanin granules (no pigmentation); 1 = rare and scattered melanin granules (mild pigmentation); 2 = dense but not aggregated melanin granules (moderate pigmentation); or 3 = dense and aggregated melanin granules (heavy pigmentation).	3 MONTHS
Secondary	PERIODONTAL PARAMETER - PLAQUE INDEX	PLAQUE INDEX; " SCORE" "CRITERIA" 0 No plaque; A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque could only be recognized by running a probe across the tooth surface area; Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin, which can be seen with the naked eyes.; Abundance of soft matter on tooth and/or on the gingival margin.	3 MONTHS
Secondary	PERIODONTAL PARAMETERS - GINGIVAL INDEX,	GINGIVAL INDEX; Score Criteria 0 Absence of inflammation/normal gingiva.; Mild inflammation, slight change in colour, slight oedema; no bleeding on probing within 30 seconds.; Moderate inflammation; moderate glazing, redness, oedema, hypertrophy and bleeding on probing.; Severe inflammation; marked redness and hypertrophy ulceration of gingival margin. Tendency to spontaneous bleeding.	3 MONTHS
Secondary	PERIODONTAL PARAMETERS - BLEEDING ON PROBING (BOP)	BLEEDING ON PROBING; BOP will be recorded as 1 (present) if it occurs within 15 secs of probing and 0 (absent) if no bleeding occurs. It will be calculated in %. After adding all the scores, total score will be divided by the total number of surfaces accessed and multiplied by 100. It will be designed as % sites	3 MONTHS
Secondary	PERIODONTAL PARAMETER - PROBING POCKET DEPTH (PPD)	PROBING POCKET DEPTH; Probing pocket depth will be measured as the distance from the gingival margin to the base of pocket. The probing depth measurements will be assessed using a calibrated manual periodontal probe (PCP-UNC 15 Hu-Friedy, Chicago, IL, USA). The probe will be inserted with a firm, gentle pressure to the bottom of the pocket and maintained parallel to the vertical axis of the tooth. Measurements will be noted at 6 sites of each tooth - mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual. Measurements will be rounded to the nearest whole millimetre.	3 MONTHS
Secondary	PERIODONTAL PARAMETER - CLINICAL ATTACHMENT LEVEL (CAL)	CLINICAL ATTACHMENT LEVEL Clinical Attachment Level will be measured as the distance between the base of the pocket and the cemento-enamel junction (CEJ). Measurements will be made at 6 sites of each tooth- mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual using UNC-15 probe.	3 MONTHS
Secondary	PERIODONTAL PARAMETERS - GINGIVAL RECESSION (GR)	GINGIVAL RECESSION; Recession will be measured as the vertical distance from the CEJ to the deepest part of gingival margin in the middle of the buccal aspect of the crown.	3 MONTHS