The Association of Blood Haemoglobin and Colour of Gums

NCT03791957 | Unknown

• 1 other identifier: riya2pigmentation
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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)
• Group A - Healthy periodontium
• Group B - Gingivitis
• Group C - Periodontitis
• 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

Conditions

Gingival Pigmentation; Gingivitis; Periodontitis; Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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) n=20

Other: Blood Haemoglobin

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, n=20

Other: Blood Haemoglobin

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 n=20

Other: Blood Haemoglobin

Interventions

Blood Haemoglobin OTHER

Routine haemotological investigation of blood haemoglobin levels in gm/dL will be recorded from withdrawn venous blood

Group A - Healthy Periodontium; Group B - Gingivitis; Group C - Periodontitis

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Subjects to be recruited from out patient pool of KLE Society's Institute of Dental Sciences, Bangalore, India

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KLE Society's Institute of Dental Sciences: lead

MeSH Terms

Conditions

Gingivitis; Periodontitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Riya A Daniel, BDS, PG student

CONTACT

9444140560; riyaad.rd@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post graduate student, Principal investigator, Department of Periodontics, KLE Society's Institute of Dental Sciences, Bangalore

Study Record Dates

• First Submitted: December 30, 2018
• First Posted: January 3, 2019
• Study Start: December 20, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share