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Clinical Trial Summary

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)

1. Group A - Healthy periodontium

2. Group B - Gingivitis

3. 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


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03791957
Study type Observational [Patient Registry]
Source KLE Society's Institute of Dental Sciences
Contact Riya A Daniel, BDS, PG student
Phone 9444140560
Email riyaad.rd@gmail.com
Status Not yet recruiting
Phase
Start date January 2019
Completion date May 2019

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