The Association of the Levels of Blood Haemoglobin to the Distribution and Severity of Gingival Melanin Pigmentation at 3 Different Periodontal Health Status
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Blood Haemoglobin to Melanin pigmentation
研究概览
简要总结
AIM:
To evaluate the association of the levels of blood haemoglobin to the distribution and severity of gingival melanin pigmentation at 3 different periodontal health status
SAMPLE SIZE ESTIMATION
- Done using GPower v.3.1.9.2
- Total sample size = 60 (20 each in 3 groups)
- Effect size = 40%
- Power = 80%
- α-error = 5%
SAMPLING:
- Simple random sampling
- Subjects to be recruited from out patient pool of KLE Society's Institute of Dental Sciences, Bangalore
- Subjects to be categorised into 3 groups (20 subjects each)
- Group A - Healthy periodontium
- Group B - Gingivitis
- Group C - Periodontitis
PARAMETERS ASSESSED
- Blood Haemoglobin Concentration (in %gm/dL)
- Hedin Melanin Index Score 0: No pigmentation Score 1: one or two solitary unit(s) of pigmentation in papillary gingiva without formation of a continuous ribbon between solitary units Score 2: More than three units of pigmentation in papillary gingiva without the formation of a continuous ribbons of pigmentation Score 3: One or more short continuous ribbons of pigmentation Score 4: One continuous ribbon including the entire area between canines
STATISTICAL ANALYSIS
- SPSS for Windows Version 22.0 to be used
- Descriptive statistics: It includes expression of study parameters in terms of Mean & SD for continuous variables, whereas in terms of frequency and proportions for categorical variables.
- Inferential Statistics:
Chi Square Test will be used to compare the pigmentation index between 03 groups. And similarly, gender wise comparison of hemoglobin concentration will be done using the same test.
One-way ANOVA test followed by Tukey's HSD post hoc Analysis will be used to compare the mean hemoglobin levels based on the pigmentation index scores in each group.
The level of significance [P-Value] was set at P<0.05
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy individuals
- •Absence of pathological gingival pigmentation
- •Group A - Healthy Periodontium: Absence of clinical signs of inflammation like bleeding on probing, erythema, edema, attachment loss, bone loss, patient symptoms, (bone levels at 1-3mm apical to CEJ)
- •Group B - Gingivitis: Presence of cardinal signs of inflammation along with, bleeding and discomfort on gentle probing, loss of knife-edged margin and blunting of papilla,
- •Group C - Periodontitis: Presence of cardinal signs of inflammation along with, bleeding and discomfort on gentle probing, loss of knife-edged margin and blunting of papilla,periodontal pocketing, clinical attachment loss, radiographically assessed bone loss
排除标准
- •Tobacco associated pigmentation - smoker's melanosis, chewing/ pouching tobacco
- •Pigmentation from exogenous pigments - amalgam tattoo, cultural tattooing, beverages, food colours, betelnut/khat chewing, heavy metals ( mercury, silver, arsenic, bismuth, graphite, lead), topical medications, other foreign bodies
- •Pigmentation from endogenous pigments - jaundice, ecchymosis/ petechiae, haemochromatosis, hemosiderin
- •Long term consumption of pigmentation causing drugs - ACTH, antimalarial drugs, busulfan, doxorubicin, minocycline, oral contraceptives, phenothiazies
- •Syndromes and systemic diseases associated with pigmentation - Addison's disease. Albright's syndrome, basila melanosis, β-thalassemia, healed / healing mucocutaneous lesions, hereditary hemorrhagic Telangiectasia, HIV-associated melanosis, Neurofibromatosis, Peutz Jeghers syndrome, hamartoma, pyogenic granuloma, epulis
- •Benign or malignant lesions involving gingival - angiosarcoma, hemangioma, Kaposi's sarcoma, malignant melanoma, melanocytic nevus, pigmented vaculoe
结局指标
主要结局
Blood Haemoglobin to Melanin pigmentation
时间窗: Baseline
To assess the association of the levels of blood haemoglobin to the distribution and severity of gingival melanin pigmentation at 3 different periodontal health status by Hedin Melanin Index both by intragroup comparison within each of the 3 groups and intergroup comparison between the three groups
次要结局
未报告次要终点
研究者
Dr. Riya Achamma Daniel
Post graduate student, Principal investigator, Department of Periodontics, KLE Society's Institute of Dental Sciences, Bangalore
KLE Society's Institute of Dental Sciences