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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- CLINICAL PARAMETER- WOUND HEALING
研究概览
简要总结
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.
详细描述
AIM: To evaluate and compare the clinical, esthetic and patient-related outcomes of gingival depigmentation performed via microsurgery vs conventional surgical 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 parameters 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).
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy patients seeking treatment for gingival hyper-pigmentation
排除标准
- •Gingival index (Loe and Sillness 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 channel blockers, which are known to influence periodontal status;
- •pregnant or lactating women;
- •history of use of tobacco;
研究组 & 干预措施
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.
干预措施: Gingival depigmentation using microsurgery (Procedure)
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.
干预措施: Conventional surgical depigmentation (Procedure)
结局指标
主要结局
CLINICAL PARAMETER- WOUND HEALING
时间窗: 3 MONTHS
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
DUMMETT ORAL PIGMENTATION INDEX (DOPI)
时间窗: 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)
Patient-related outcome measures (PROMs) - ESTHETIC SATISFACTION
时间窗: 3 months
ESTHETIC SATISFACTION WILL BVE EVALUATED AS PER PATIENT'S RESPONSE TO PREFERRED CHOICE OF TREATMENT - CONVENTIONAL OR MICROSURGICAL
CLINICAL PARAMETER- swelling
时间窗: 3 MONTHS
swelling score classified in accordance to Ishi et al and Kawashima et al A: NONE B: SLIGHT C: MODERATE D: SEVERE
CLINICAL PARAMETER- Gingival color
时间窗: 3 MONTHS
Gingival Color A: IMPROVEMENT B: SLIGHT IMPROVEMENT C: NO CHANGE D: DETERIORATION
HEDIN MELANIN INDEX (HMI)
时间窗: 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
Patient-related outcome measures (PROMs) - post-operative pain perception
时间窗: 3 months
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.
CLINICAL PARAMETER- Bleeding
时间窗: 3 MONTHS
bleeding score classified in accordance to Ishi et al and Kawashima et al A: NONE B: SLIGHT C: MODERATE D: SEVERE
CLINICAL PARAMETER- REDNESS
时间窗: 3 MONTHS
redness score classified in accordance to Ishi et al and Kawashima et al A: NONE B: SLIGHT C: MODERATE D: SEVERE
次要结局
- MELANOCYTE HISTOPATHOLOGIC COUNT (MHC)(3 MONTHS)
- PERIODONTAL PARAMETER - CLINICAL ATTACHMENT LEVEL (CAL)(3 MONTHS)
- PERIODONTAL PARAMETER - PLAQUE INDEX(3 MONTHS)
- PERIODONTAL PARAMETER - PROBING POCKET DEPTH (PPD)(3 MONTHS)
- PERIODONTAL PARAMETERS - GINGIVAL RECESSION (GR)(3 MONTHS)
- PERIODONTAL PARAMETERS - GINGIVAL INDEX,(3 MONTHS)
- PERIODONTAL PARAMETERS - BLEEDING ON PROBING (BOP)(3 MONTHS)