Comparative Evaluation of Microsurgery vs Diode Laser Technique of Gingival Depigmentation
- Conditions
- MelanosisGingival Pigmentation
- Interventions
- Procedure: Gingival depigmentation using microsurgeryProcedure: Gingival Depigmentation using Diode Laser
- Registration Number
- NCT05930366
- Lead Sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 22
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gingival depigmentation using microsurgery Gingival depigmentation using microsurgery Surgical excision of hyper-pigmented gingival tissue using microsurgical blade (keratome 2.2) and magnification loupes under local anaesthesia. Gingival Depigmentation using Diode Laser Gingival Depigmentation using Diode Laser Ablation of hyper-pigmented gingival tissue using Diode Laser under local anaesthesia.
- Primary Outcome Measures
Name Time Method CLINICAL PARAMETER- WOUND HEALING 3 MONTHS wound healing score classification in accordance to Ishi et al and Kawashima et al
A: COMPLETE EPITHELIALIZATION B: INCOMPLETE OR PARTIAL EPITHELIALIZATION C: ULCER D: TRISSUE EFECT OR NECROSISCLINICAL PARAMETER- GINGIVAL COLOR 3 MONTHS gingival color score classification in accordance to Ishi et al and Kawashima et al
A: IMPROVEMENT B: SLIGHT IMPROVEMENT C: NO CHANGE D: DETERIORATIONDUMMETT ORAL PIGMENTATION INDEX (DOPI) 3 MONTHS DOPI
Score Criteria 0 Pink tissue (no clinical pigmentation)
1. Mild light brown tissue (mild clinical pigmentation)
2. Medium brown or mixed brown and pink tissue (moderate clinical pigmentation)
3. Deep brown/ blue-black tissue (heavy clinical pigmentation)HEDIN MELANIN INDEX (HMI) 3 MONTHS HMI
Score Criteria 0 No pigmentation
1. One or two solitary units of pigmentation in the papillary gingiva
2. \>3 units of pigmen- tation in the papillary gingiva without formation of a continuous ribbon
3. More than equal to 1 short continuous ribbons of pigmentation
4. One continuous ribbon including the entire area between the caninesCLINICAL PARAMETER- BLEEDING 3 MONTHS Bleeding score classification in accordance to Ishi et al and Kawashima et al
A: NONE B: SLIGHT C: MODERATE D: SEVERECLINICAL PARAMETER- REDNESS 3 MONTHS Redness score classification in accordance to Ishi et al and Kawashima et al
A: NONE B: SLIGHT C: MODERATE D: SEVEREPatient-related outcome measures (PROMs) - ESTHETIC SATISFACTION 3 MONTHS OVERALL ESTHETIC SATISFACTION WILL BE EVALUATED AS PER PATIENTS REPSONSE TO PREFERRED CHOICE OF TREATMENT - MICROSURGICAL OR DIODE LASER
CLINICAL PARAMETERS- SWELLING 3 MONTHS Swelling score classification in accordance to Ishi et al and Kawashima et al
A: NONE B: SLIGHT C: MODERATE D: SEVEREPatient-related outcome measures (PROMs) - POST-OPERATIVE PAIN PERCEPTION 3 MONTHS post-operative pain perception/discomfort and esthetic satisfaction on a visual analog scale (VAS)
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.
- Secondary Outcome Measures
Name Time Method PERIODONTAL PARAMETER - PROBING POCKET DEPTH (PPD) 3 MONTHS PROBING POCKET DEPTH (PPD)
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.PERIODONTAL PARAMETER- PLAQUE INDEX (PI) 3 MONTHS PLAQUE INDEX (PI)
" SCORE" " CRITERIA" 0 No plaque
1. 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
2. Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin, which can be seen with the naked eyes.
3. Abundance of soft matter on tooth and/or on the gingival margin.PERIODONTAL PARAMETER- BLEEDING ON PROBING (BOP) 3 MONTHS BLEEDING ON PROBING (BOP)
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 % sitesMELANOCYTE HISTOPATHOLOGIC COUNT (MHC) 3 MONTHS EFFECT ON MHC
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).PERIODONTAL PARAMETER - GINGIVAL INDEX (GI) 3 MONTHS GINGIVAL INDEX (GI)
Score Criteria 0 Absence of inflammation/normal gingiva.
1. Mild inflammation, slight change in colour, slight oedema; no bleeding on probing within 30 seconds.
2. Moderate inflammation; moderate glazing, redness, oedema, hypertrophy and bleeding on probing.
3. Severe inflammation; marked redness and hypertrophy ulceration of gingival margin. Tendency to spontaneous bleeding.PERIODONTAL PARAMETER - CLINICAL ATTACHMENT LEVEL (CAL) 3 MONTHS CLINICAL ATTACHMENT LEVEL (CAL)
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 probePERIODONTAL PARAMETER - GINGIVAL RECESSION (GR) 3 MONTHS GR 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.
Trial Locations
- Locations (1)
Post graduate institute of dental sciences
🇮🇳Rohtak, Haryana, India