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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-05-01', 'releaseDate': '2020-04-21'}], 'estimatedResultsFirstSubmitDate': '2020-04-21'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}, {'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '1 Week', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-12-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-13', 'studyFirstSubmitDate': '2018-12-30', 'studyFirstSubmitQcDate': '2018-12-30', 'lastUpdatePostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Haemoglobin to Melanin pigmentation', 'timeFrame': 'Baseline', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Pigmentation', 'Gingivitis', 'Periodontitis', 'Healthy']}, 'descriptionModule': {'briefSummary': "AIM:\n\nTo evaluate the association of the levels of blood haemoglobin to the distribution and severity of gingival melanin pigmentation at 3 different periodontal health status\n\nSAMPLE SIZE ESTIMATION\n\n* Done using GPower v.3.1.9.2\n* Total sample size = 60 (20 each in 3 groups)\n* Effect size = 40%\n* Power = 80%\n* α-error = 5%\n\nSAMPLING:\n\n* Simple random sampling\n* Subjects to be recruited from out patient pool of KLE Society's Institute of Dental Sciences, Bangalore\n* Subjects to be categorised into 3 groups (20 subjects each)\n\n 1. Group A - Healthy periodontium\n 2. Group B - Gingivitis\n 3. Group C - Periodontitis\n\nPARAMETERS ASSESSED\n\n* Blood Haemoglobin Concentration (in %gm/dL)\n* 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\n\nSTATISTICAL ANALYSIS\n\n* SPSS for Windows Version 22.0 to be used\n* 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.\n* Inferential Statistics:\n\nChi 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.\n\nOne-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.\n\nThe level of significance \\[P-Value\\] was set at P\\<0.05"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Subjects to be recruited from out patient pool of KLE Society's Institute of Dental Sciences, Bangalore, India", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Systemically healthy individuals\n* Absence of pathological gingival pigmentation\n\n 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)\n 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,\n 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\n\nExclusion Criteria:\n\n* Tobacco associated pigmentation - smoker's melanosis, chewing/ pouching tobacco\n* 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\n* Pigmentation from endogenous pigments - jaundice, ecchymosis/ petechiae, haemochromatosis, hemosiderin\n* Long term consumption of pigmentation causing drugs - ACTH, antimalarial drugs, busulfan, doxorubicin, minocycline, oral contraceptives, phenothiazies\n* 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\n* Benign or malignant lesions involving gingival - angiosarcoma, hemangioma, Kaposi's sarcoma, malignant melanoma, melanocytic nevus, pigmented vaculoe"}, 'identificationModule': {'nctId': 'NCT03791957', 'briefTitle': 'The Association of Blood Haemoglobin and Colour of Gums', 'organization': {'class': 'OTHER', 'fullName': "KLE Society's Institute of Dental Sciences"}, 'officialTitle': 'The Association of the Levels of Blood Haemoglobin to the Distribution and Severity of Gingival Melanin Pigmentation at 3 Different Periodontal Health Status', 'orgStudyIdInfo': {'id': 'riya2pigmentation'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A - Healthy Periodontium', 'description': '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', 'interventionNames': ['Other: Blood Haemoglobin']}, {'label': 'Group B - Gingivitis', 'description': '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', 'interventionNames': ['Other: Blood Haemoglobin']}, {'label': 'Group C - Periodontitis', 'description': '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', 'interventionNames': ['Other: Blood Haemoglobin']}], 'interventions': [{'name': 'Blood Haemoglobin', 'type': 'OTHER', 'description': 'Routine haemotological investigation of blood haemoglobin levels in gm/dL will be recorded from withdrawn venous blood', 'armGroupLabels': ['Group A - Healthy Periodontium', 'Group B - Gingivitis', 'Group C - Periodontitis']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Riya A Daniel, BDS, PG student', 'role': 'CONTACT', 'email': 'riyaad.rd@gmail.com', 'phone': '9444140560', 'phoneExt': '+91'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "KLE Society's Institute of Dental Sciences", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Post graduate student, Principal investigator, Department of Periodontics, KLE Society's Institute of Dental Sciences, Bangalore", 'investigatorFullName': 'Dr. Riya Achamma Daniel', 'investigatorAffiliation': "KLE Society's Institute of Dental Sciences"}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-04-21', 'type': 'RELEASE'}, {'date': '2020-05-01', 'type': 'RESET'}], 'unpostedResponsibleParty': "Dr. Riya Achamma Daniel, Post graduate student, Principal investigator, Department of Periodontics, KLE Society's Institute of Dental Sciences, Bangalore, KLE Society's Institute of Dental Sciences"}}}}