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Estimation of Interleukin-21 Levels in Gingival Crevicular Fluid in Patients With Periodontal Health and Disease Following Non-surgical Periodontal Therapy: A Clinico-biochemical Study

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ClinicalTrials.gov Identifier: NCT02861937
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Krishnadevaraya College of Dental Sciences & Hospital

Brief Summary:
Human IL-21 is present in gingival crevicular fluid in periodontal health, gingivitis and chronic periodontitis. A significant increase in the concentration of IL-21 in gingival crevicular fluid is observed with an increase in the amount of periodontal destruction. Non- surgical periodontal therapy aided in decrease of GCF IL-21 levels in clinical gingivitis and chronic periodontitis

Condition or disease Intervention/treatment Phase
Chronic Peridontitis Patients Chronic Gingivitis Healthy Procedure: non surgical periodontal therapy Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Estimation of Interleukin-21 Levels in Gingival Crevicular Fluid in Patients With Periodontal Health and Disease Following Non-surgical Periodontal Therapy: A Clinico-biochemical Study
Study Start Date : April 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
No Intervention: healthy
Active Comparator: chronic gingivitis
Chronic gingivitis was defined as having probing depth (PD) less than or equal to 4mm, relative attachment loss (RAL) ) less than or equal to 3mm and more than to 25% sites with gingival bleeding present (BOP)
Procedure: non surgical periodontal therapy
Active Comparator: chronic periodontitis
Chronic periodontitis was defined as having probing depth more than or equal to 5mm, RAL more than or equal to 8mm, with more than or equal to 10% sites with BOP positive and evidence of bone loss determined radiographically.
Procedure: non surgical periodontal therapy



Primary Outcome Measures :
  1. pocket dept [ Time Frame: 6 weeks ]
    evaluated for all the teeth excluding 3rd molars, at all the six sites for each tooth (mesio-buccal, disto-buccal, disto-lingual, mid-lingual and mesiolingual

  2. assessment of gingival bleeding i.e gingival index [ Time Frame: 6 weeks ]
    evaluated for all the teeth excluding 3rd molars, at all the six sites for each tooth (mesio-buccal, disto-buccal, disto-lingual, mid-lingual and mesiolingual

  3. plaque index [ Time Frame: 6 weeks ]
    evaluated for all the teeth excluding 3rd molars, at all the six sites for each tooth (mesio-buccal, disto-buccal, disto-lingual, mid-lingual and mesiolingual

  4. bleeding on probing [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   20 Years to 20 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients having more than or equal to 14 functional teeth, systemically healthy patients who had not received any form of surgical and non surgical periodontal therapy or received antibiotics or non-steroidal anti-inflammatory

Exclusion Criteria:

  • smokers pregnant females

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Responsible Party: Krishnadevaraya College of Dental Sciences & Hospital
ClinicalTrials.gov Identifier: NCT02861937     History of Changes
Other Study ID Numbers: 02-D012-36773
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
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Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases