The Association of Blood Haemoglobin and Colour of Gums

Healthy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03791957
• Other study ID #: riya2pigmentation
• Status: Not yet recruiting
• Start date: December 20, 2019
• Est. completion date: January 2020

Study information

• Verified date: December 2019
• Source: KLE Society's Institute of Dental Sciences
• Contact: Riya A Daniel, BDS, PG student
• Phone: 9444140560
• Email: riyaad.rd[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Systemically healthy individuals

• Absence of pathological gingival pigmentation

1. 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)

2. 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,

3. 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, ß-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

Related Conditions & MeSH terms

• Gingival Pigmentation
• Gingivitis
• Healthy
• Periodontitis

Intervention

Other:
• Blood Haemoglobin
Routine haemotological investigation of blood haemoglobin levels in gm/dL will be recorded from withdrawn venous blood

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KLE Society's Institute of Dental Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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