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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

Tracking Information
First Submitted Date  ICMJE August 3, 2018
First Posted Date  ICMJE August 8, 2018
Last Update Posted Date August 13, 2018
Actual Study Start Date  ICMJE October 15, 2016
Actual Primary Completion Date January 17, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
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 (Eppendorff tubes) for serum Trefoil Factor 3.
Change History Complete list of historical versions of study NCT03620396 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
  • 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
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
  • 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 gingitis 2.1-3.0:Severe gingivitis
  • Change in Modified Plaque Index [ Time Frame: 3 months ]
    Examination of all the srufaces 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 [ Time Frame: 3 months ]
    The distance from the gingival margin to the depth of the pocket is measured using Williams periodontal probe.
  • Change in Clinical Attachment loss [ Time Frame: 3 months ]
    The distace from the cemento enamel junction to the tip of the alveolar crest is measures using Williams periodontal probe.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Serum Trefoil Factor 3 in Patients With Gingivitis and Periodontitis After Scaling and Root Planing
Official Title  ICMJE Comparison of Serum Levels of Trefoil Factor 3 in Patients With Gingivitis and Periodontitis Following Non Surgical Periodontal Therapy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Gingivitis and Periodontal Diseases
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Scaling and root planing
  • 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.
    Intervention: Procedure: Scaling and root planing
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2018)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 19, 2017
Actual Primary Completion Date January 17, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03620396
Other Study ID Numbers  ICMJE Panineeya Mahavidyalaya
D159206045 ( Other Identifier: Dr.NTR University of Health Sciences )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr.K.Sai Priyanka, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Study Sponsor  ICMJE Dr.K.Sai Priyanka
Collaborators  ICMJE Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Investigators  ICMJE Not Provided
PRS Account Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP