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

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ClinicalTrials.gov Identifier: NCT03620396
Recruitment Status : Completed
First Posted : August 8, 2018
Last Update Posted : August 13, 2018
Sponsor:
Collaborator:
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Information provided by (Responsible Party):
Dr.K.Sai Priyanka, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

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.

Condition or disease Intervention/treatment Phase
Gingivitis and Periodontal Diseases Procedure: Scaling and root planing Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Serum Levels of Trefoil Factor 3 in Patients With Gingivitis and Periodontitis Following Non Surgical Periodontal Therapy
Actual Study Start Date : October 15, 2016
Actual Primary Completion Date : January 17, 2017
Actual Study Completion Date : February 19, 2017

Arm Intervention/treatment
Experimental: Experimental: Interventional
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.
Procedure: Scaling and root planing
After the serum collection is done from the patient for the assessment of trefoil factor 3, Non surgical periodontal therapy is carried out.

Experimental: Experimental Interventional
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.
Procedure: Scaling and root planing
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 Measures :
  1. Trefoil factor 3 [ Time Frame: 3 months. ]
    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 :
  1. Change in the Gingival Index. [ Time Frame: 3 months ]

    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


  2. Change in Modified Plaque Index [ Time Frame: 3 months ]

    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


  3. Change in Probing depth [ Time Frame: 3 months ]
    The distance from the gingival margin to the depth of the pocket is measured using Williams periodontal probe.

  4. Change in Clinical Attachment loss [ Time Frame: 3 months ]
    The distance from the cementoenamel junction to the tip of the alveolar crest is measures using Williams periodontal probe.



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Publications:
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Responsible Party: Dr.K.Sai Priyanka, Student, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
ClinicalTrials.gov Identifier: NCT03620396     History of Changes
Other Study ID Numbers: Panineeya Mahavidyalaya
D159206045 ( Other Identifier: Dr.NTR University of Health Sciences )
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Gingivitis
Mouth Diseases
Stomatognathic Diseases
Gingival Diseases