Status:

UNKNOWN

The Association of Blood Haemoglobin and Colour of Gums

Lead Sponsor:

KLE Society's Institute of Dental Sciences

Conditions:

Gingival Pigmentation

Gingivitis

Eligibility:

All Genders

20-60 years

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 ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

December 20 2019

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 1 2020

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT03791957

Start Date

December 20 2019

End Date

January 1 2020

Last Update

December 17 2019

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