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Effect of Non-surgical Periodontal Therapy on Gingival Crevicular Fluid Interleukin-21 Levels

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ClinicalTrials.gov Identifier: NCT02861937
Recruitment Status : Completed
First Posted : August 10, 2016
Results First Posted : August 26, 2020
Last Update Posted : September 2, 2020
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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A total of 34 patients with 19 males and 15 females in the age group of 20-60 years were included. Patients were divided into 3 groups to collect Gingival Crevicular Fluid (GCF) samples for the study.
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

Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present.

As there was no attachment loss, it was not necessary for us to calculate RAL ( Relative Attachment Level)

Active Comparator: chronic gingivitis

Chronic gingivitis was defined as having probing depth (PD) less than or equal to 4mm and more than to 25% sites with the gingival bleeding present (BOP)

As there was no attachment loss, it was not necessary for us to calculate RAL ( Relative Attachment Level)

Non surgical periodontal therapy (SRP) was concluded in 3 weeks. Within the duration of the study, all subjects received supportive therapy

Procedure: non surgical periodontal therapy
and root planing (SRP) was performed in two to four appointments lasting approximately 60 minutes each under local anaesthesia (2% lignocaine hydrochloride with 1:2,00,000 adrenaline) using area specific Gracey periodontal curettes and an ultrasonic device. The treatment was concluded in 3 weeks. Within the duration of the study, all subjects received supportive therapy, which included professional plaque control and reinstruction of oral hygiene.

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.

Non surgical periodontal therapy (SRP) was concluded in 3 weeks. Within the duration of the study, all subjects received supportive therapy

Procedure: non surgical periodontal therapy
and root planing (SRP) was performed in two to four appointments lasting approximately 60 minutes each under local anaesthesia (2% lignocaine hydrochloride with 1:2,00,000 adrenaline) using area specific Gracey periodontal curettes and an ultrasonic device. The treatment was concluded in 3 weeks. Within the duration of the study, all subjects received supportive therapy, which included professional plaque control and reinstruction of oral hygiene.




Primary Outcome Measures :
  1. Pocket Depth [ Time Frame: 6 weeks ]
    Probing pocket depth (PPD) was recorded using University of North Carolina {UNC}-15 Periodontal probe and customized occlusal stent. Pocket depth was recorded from the crest of the gingival margin to the base of the pocket. The deepest probing pocket depth in the patient"s mouth was considered.

  2. Gingival Index [ Time Frame: 6 weeks ]

    The severity of Gingivitis was scored on the distolabial papillae, facial margins, mesiolabial papillae and entire lingual gingival margin of each tooth. A blunt instrument such as Periodontal probe was used to assess the bleeding.

    0-Absence of inflammation/normal gingival

    1. Mild inflammation, slight change in color, slight edema; no bleeding on probing
    2. Moderate inflammation; moderate glazing, redness, edema and hypertrophy. Bleeding on probing.The higher the score,worst the outcome
    3. Severe inflammation; marked redness, hypertrophy and ulceration. Tendency to spontaneous bleeding.

    Gingival Score Degree of gingivitis 0.1-1.0-Mild gingivitis 1.1-2.0-Moderate gingivitis 2.1-3.0-Severe gingivitis


  3. Plaque Index [ Time Frame: 6 weeks ]

    The surfaces examined are the four gingival areas of the tooth i,e the distolabial, facial, mesiolabial, and lingual surfaces. Mouth mirror, a light source, a dental explorer, and air drying of the teeth and gingiva were used.

    SCORE CRITERIA 0 No plaque in gingival area

    1. No plaque can be observed by naked eye. A film of plaque adhering to the free gingival margin and adjacent area of the tooth recognized only by running a probe across the tooth surface.
    2. Moderate accumulation of soft deposits within the gingival pockets or on the tooth and gingival margin, which can be seen with naked eye.
    3. Abundance of soft matter within the gingival pocket and or on the tooth surface and gingival margin. The interdental area is stuffed with soft debris.

    Plaque Score:Oral Hygiene Status 0:Excellent 0.1-0.9:Good 1.0-1.9:Fair 2.0-3.0:Poor. The higher the value,worst is the outcome.


  4. Relative Attachment Level: [ Time Frame: 6 weeks ]

    RAL was measured using UNC-15 periodontal probe and customized acrylic stent. This measurement was made from a fixed reference point from the occlusal surface of the acrylic stent to the base of the periodontal pocket.

    No Relative Attachment Level (RAL) :healthy No Relative Attachment Level (RAL) : chronic gingivitis Relative Attachment Level (RAL) more than or equal to 8mm : chronic periodontitis


  5. Interleukin-21(IL-21) Cytokine Levels [ Time Frame: 6 weeks ]
    IL-21 levels in Gingival crevicular fluid {GCF} was determined by using ELISA kit. Quantikine human IL-21 immunoassay was done according to manufacturer"s instructions (MABTECH SWEDEN)®. ELISA reader was used to record the optical density of the tested samples.



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Ages Eligible for Study:   20 Years to 60 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861937


Sponsors and Collaborators
Krishnadevaraya College of Dental Sciences & Hospital
Investigators
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Study Director: Rudrakshi Chickanna, MDS Krishnadevaraya college of dental sciences
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Responsible Party: Krishnadevaraya College of Dental Sciences & Hospital
ClinicalTrials.gov Identifier: NCT02861937    
Other Study ID Numbers: 02-D012-36773
First Posted: August 10, 2016    Key Record Dates
Results First Posted: August 26, 2020
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases