Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-24 @ 10:54 AM
Study NCT ID:
NCT03791957
Status:
UNKNOWN
Last Update Posted:
2019-12-17
First Post:
2018-12-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Association of Blood Haemoglobin and Colour of Gums
Sponsor:
KLE Society's Institute of Dental Sciences
Organization:
Study Overview
Official Title:
The Association of the Levels of Blood Haemoglobin to the Distribution and Severity of Gingival Melanin Pigmentation at 3 Different Periodontal Health Status
Status:
UNKNOWN
Status Verified Date:
2019-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: