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Comparison of Serum Trefoil Factor 3 in Patients With Gingivitis and Periodontitis After Scaling and Root Planing (CSTF3PGPSR)

Primary Purpose

Gingivitis and Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Scaling and root planing
Sponsored by
Dr.K.Sai Priyanka
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis and Periodontal Diseases

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

For Gingivitis:

  • Gingival Index: 1.1 to 2.
  • Modifies Plaque Index: 1.0 to 1.9

For Periodontitis:

  • Gingival Index: 1.1 to 2.
  • Modifies Plaque Index: 1.0 to 1.9
  • Probing depth > 4mm
  • Clinical attachment loss > 2mm

Exclusion Criteria:

For Gingivitis:

  • Presence of gingival recession.
  • Presence of clinical attachment loss.
  • Presence of furcation.
  • Presence of systemic infections like diabetes, infections.
  • Smokers.
  • Antibiotic therapy received preceding 3 months.
  • Patients who underwent periodontal therapy within 3 months.
  • Pregnant and Lactating women.

For Periodontitis:

  • Presence of any systemic conditions like diabetes, infections.
  • Smokers.
  • Antibiotic therapy received preceding 3 months.
  • Patients who underwent periodontal therapy within 3 months.
  • Pregnant and Lactating women.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Experimental: Interventional

    Experimental Interventional

    Arm Description

    Group A patients consists of Gingivitis patients whose serum is collected at base line and treated with Scaling and root planing and after three months serum is collected for assessment of Trefoil factor 3.

    Group B patients consists of Periodontitis patients whose serum is collected at base line and treated with Scaling and Root Planing and after three months serum is collected for assessment of Trefoil factor 3.

    Outcomes

    Primary Outcome Measures

    Trefoil factor 3
    Blood samples were collected by venepuncture of anti-cubital vein. 2ml of blood was collected in each test tube. 10 minutes after collection, the test tube containing 2ml blood was subjected to centrifugation at 3000rpm for 10 min. The supernatant straw colored fluid (serum) was separated into storage vials (Eppendorf tubes) for serum Trefoil Factor 3.

    Secondary Outcome Measures

    Change in the Gingival Index.
    The severity of gingivitis is scored on all surfaces of selected teeth using Williams Periodontal probe. Index teeth- 16, 12, 24, 36, 32, 44. Score around each tooth is totalled and divided by 4-score of tooth. 0.1-1.0: Mild gingivitis. 1.1-2.0:Moderate gingivitis 2.1-3.0:Severe gingivitis
    Change in Modified Plaque Index
    Examination of all the surfaces of the teeth are done using an explorer. The scores for individual teeth may be grouped and totalled and divided by the number of teeth. Excellent:0 Good:0.1-0.9 Fair:1.0-1.9 Poor:2-3
    Change in Probing depth
    The distance from the gingival margin to the depth of the pocket is measured using Williams periodontal probe.
    Change in Clinical Attachment loss
    The distance from the cementoenamel junction to the tip of the alveolar crest is measures using Williams periodontal probe.

    Full Information

    First Posted
    August 3, 2018
    Last Updated
    August 9, 2018
    Sponsor
    Dr.K.Sai Priyanka
    Collaborators
    Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03620396
    Brief Title
    Comparison of Serum Trefoil Factor 3 in Patients With Gingivitis and Periodontitis After Scaling and Root Planing
    Acronym
    CSTF3PGPSR
    Official Title
    Comparison of Serum Levels of Trefoil Factor 3 in Patients With Gingivitis and Periodontitis Following Non Surgical Periodontal Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 15, 2016 (Actual)
    Primary Completion Date
    January 17, 2017 (Actual)
    Study Completion Date
    February 19, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dr.K.Sai Priyanka
    Collaborators
    Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is intended to measure serum trefoil factor 3 at baseline and 3 months after, following nonsurgical periodontal therapy in patients with Gingivitis and Chronic Periodontitis.
    Detailed Description
    A goal of periodontal diagnostic procedure is to provide useful information to the clinician regarding the present periodontal disease type and severity. Advances in diagnostic research are moving towards methods where periodontal risk can be identified and quantified by objective measures such as Biomarkers. Trefoil factors (TFFs) are one such secreted molecules derived from mucin producing epithelial cells of the gastro intestinal tracts and other tissues such as Salivary glands, Parotid ducts and oral mucosa. Among three Trefoil factors reported, Trefoil Factor 3 (TFF3) is the modifying factor for signalling pathway involved in cell survival, cell proliferation and cell migration of oral keratinocytes. Hence assessing the marker levels would achieve beneficial effects on diagnosing the disease severity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingivitis and Periodontal Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients will be equally divided into two test groups.Group A consists of Gingivitis patients and Group B consists of Periodontitis patients. Both the group patients have been evaluated for Serum Trefoil factor 3 at baseline and treated with non surgical periodontal therapy. After three months both the group patients were again assessed for serum trefoil factor 3.
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental: Interventional
    Arm Type
    Experimental
    Arm Description
    Group A patients consists of Gingivitis patients whose serum is collected at base line and treated with Scaling and root planing and after three months serum is collected for assessment of Trefoil factor 3.
    Arm Title
    Experimental Interventional
    Arm Type
    Experimental
    Arm Description
    Group B patients consists of Periodontitis patients whose serum is collected at base line and treated with Scaling and Root Planing and after three months serum is collected for assessment of Trefoil factor 3.
    Intervention Type
    Procedure
    Intervention Name(s)
    Scaling and root planing
    Intervention Description
    After the serum collection is done from the patient for the assessment of trefoil factor 3, Non surgical periodontal therapy is carried out.
    Primary Outcome Measure Information:
    Title
    Trefoil factor 3
    Description
    Blood samples were collected by venepuncture of anti-cubital vein. 2ml of blood was collected in each test tube. 10 minutes after collection, the test tube containing 2ml blood was subjected to centrifugation at 3000rpm for 10 min. The supernatant straw colored fluid (serum) was separated into storage vials (Eppendorf tubes) for serum Trefoil Factor 3.
    Time Frame
    3 months.
    Secondary Outcome Measure Information:
    Title
    Change in the Gingival Index.
    Description
    The severity of gingivitis is scored on all surfaces of selected teeth using Williams Periodontal probe. Index teeth- 16, 12, 24, 36, 32, 44. Score around each tooth is totalled and divided by 4-score of tooth. 0.1-1.0: Mild gingivitis. 1.1-2.0:Moderate gingivitis 2.1-3.0:Severe gingivitis
    Time Frame
    3 months
    Title
    Change in Modified Plaque Index
    Description
    Examination of all the surfaces of the teeth are done using an explorer. The scores for individual teeth may be grouped and totalled and divided by the number of teeth. Excellent:0 Good:0.1-0.9 Fair:1.0-1.9 Poor:2-3
    Time Frame
    3 months
    Title
    Change in Probing depth
    Description
    The distance from the gingival margin to the depth of the pocket is measured using Williams periodontal probe.
    Time Frame
    3 months
    Title
    Change in Clinical Attachment loss
    Description
    The distance from the cementoenamel junction to the tip of the alveolar crest is measures using Williams periodontal probe.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: For Gingivitis: Gingival Index: 1.1 to 2. Modifies Plaque Index: 1.0 to 1.9 For Periodontitis: Gingival Index: 1.1 to 2. Modifies Plaque Index: 1.0 to 1.9 Probing depth > 4mm Clinical attachment loss > 2mm Exclusion Criteria: For Gingivitis: Presence of gingival recession. Presence of clinical attachment loss. Presence of furcation. Presence of systemic infections like diabetes, infections. Smokers. Antibiotic therapy received preceding 3 months. Patients who underwent periodontal therapy within 3 months. Pregnant and Lactating women. For Periodontitis: Presence of any systemic conditions like diabetes, infections. Smokers. Antibiotic therapy received preceding 3 months. Patients who underwent periodontal therapy within 3 months. Pregnant and Lactating women.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22181686
    Citation
    Chaiyarit P, Chayasadom A, Wara-Aswapati N, Hormdee D, Sittisomwong S, Nakaresisoon S, Samson MH, Pitiphat W, Giraud AS. Trefoil factors in saliva and gingival tissues of patients with chronic periodontitis. J Periodontol. 2012 Sep;83(9):1129-38. doi: 10.1902/jop.2011.110431. Epub 2011 Dec 19.
    Results Reference
    background
    PubMed Identifier
    20121925
    Citation
    Storesund T, Schreurs O, Messelt EB, Kolltveit KM, Schenck K. Trefoil factor family 3 expression in the oral cavity. Eur J Oral Sci. 2009 Dec;117(6):636-43. doi: 10.1111/j.1600-0722.2009.00679.x.
    Results Reference
    background

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    Comparison of Serum Trefoil Factor 3 in Patients With Gingivitis and Periodontitis After Scaling and Root Planing

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