Healthy Clinical Trial - The Association of Blood Haemoglobin & Colour of

Status Not yet recruiting

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

Clinical Trial Details

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	December 20, 2019
Completion date	January 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Association of Blood Haemoglobin and Colour of Gums

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms