The Association of Blood Haemoglobin and Colour of Gums

Study Overview
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Brief Summary
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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

Official Title
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The Association of the Levels of Blood Haemoglobin to the Distribution and Severity of Gingival Melanin Pigmentation at 3 Different Periodontal Health Status

Conditions
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Gingival Pigmentation, Gingivitis, Periodontitis, Healthy

Intervention / Treatment
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* Other: Blood Haemoglobin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A - Healthy Periodontium<br>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) n=20 | Other: Blood Haemoglobin<br>* Routine haemotological investigation of blood haemoglobin levels in gm/dL will be recorded from withdrawn venous blood<br>|
| Group B - Gingivitis<br>Presence of cardinal signs of inflammation along with, bleeding and discomfort on gentle probing, loss of knife-edged margin and blunting of papilla, n=20 | Other: Blood Haemoglobin<br>* Routine haemotological investigation of blood haemoglobin levels in gm/dL will be recorded from withdrawn venous blood<br>|
| Group C - Periodontitis<br>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 n=20 | Other: Blood Haemoglobin<br>* Routine haemotological investigation of blood haemoglobin levels in gm/dL will be recorded from withdrawn venous blood<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Haemoglobin to Melanin pigmentation | 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 | Baseline |