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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- CLINICAL PARAMETER- WOUND HEALING
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Systemically healthy patients seeking treatment for gingival hyper-pigmentation.
Exclusion Criteria
- •Gingival index (Leo and silliness 1963) of greater than or equal to 1 at any site of surgical field.
- •Patients with periodontitis
- •Patients with pathologic or drug-induced gingival hyper-pigmentation
- •Patients with history of systemic illness with the potential to influence the
- •Periodontal status or outcome of periodontal intervention;
- •Patients with Miller Grade II /Grade III tooth mobility;
- •Patients taking medications such as NSAIDS, corticosteroids, statins or calcium 8
- •Channel blockers, which are known to influence periodontal status;
- •Pregnant or lactating women;
- •History of use of tobacco;
Arms & Interventions
Gingival depigmentation using microsurgery
Surgical excision of hyper-pigmented gingival tissue using microsurgical blade (keratome 2.2) and magnification loupes under local anaesthesia.
Intervention: Gingival depigmentation using microsurgery (Procedure)
Gingival Depigmentation using Diode Laser
Ablation of hyper-pigmented gingival tissue using Diode Laser under local anaesthesia.
Intervention: Gingival Depigmentation using Diode Laser (Procedure)
Outcomes
Primary Outcomes
CLINICAL PARAMETER- WOUND HEALING
Time Frame: 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 NECROSIS
CLINICAL PARAMETER- GINGIVAL COLOR
Time Frame: 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: DETERIORATION
DUMMETT ORAL PIGMENTATION INDEX (DOPI)
Time Frame: 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)
Time Frame: 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 canines
CLINICAL PARAMETER- BLEEDING
Time Frame: 3 MONTHS
Bleeding score classification in accordance to Ishi et al and Kawashima et al A: NONE B: SLIGHT C: MODERATE D: SEVERE
CLINICAL PARAMETER- REDNESS
Time Frame: 3 MONTHS
Redness score classification in accordance to Ishi et al and Kawashima et al A: NONE B: SLIGHT C: MODERATE D: SEVERE
Patient-related outcome measures (PROMs) - ESTHETIC SATISFACTION
Time Frame: 3 MONTHS
OVERALL ESTHETIC SATISFACTION WILL BE EVALUATED AS PER PATIENTS REPSONSE TO PREFERRED CHOICE OF TREATMENT - MICROSURGICAL OR DIODE LASER
CLINICAL PARAMETERS- SWELLING
Time Frame: 3 MONTHS
Swelling score classification in accordance to Ishi et al and Kawashima et al A: NONE B: SLIGHT C: MODERATE D: SEVERE
Patient-related outcome measures (PROMs) - POST-OPERATIVE PAIN PERCEPTION
Time Frame: 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 Outcomes
- PERIODONTAL PARAMETER - PROBING POCKET DEPTH (PPD)(3 MONTHS)
- PERIODONTAL PARAMETER- PLAQUE INDEX (PI)(3 MONTHS)
- PERIODONTAL PARAMETER- BLEEDING ON PROBING (BOP)(3 MONTHS)
- MELANOCYTE HISTOPATHOLOGIC COUNT (MHC)(3 MONTHS)
- PERIODONTAL PARAMETER - GINGIVAL INDEX (GI)(3 MONTHS)
- PERIODONTAL PARAMETER - CLINICAL ATTACHMENT LEVEL (CAL)(3 MONTHS)
- PERIODONTAL PARAMETER - GINGIVAL RECESSION (GR)(3 MONTHS)