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

August 9, 2018 updated by: Dr.K.Sai Priyanka

Comparison of Serum Levels of Trefoil Factor 3 in Patients With Gingivitis and Periodontitis Following Non Surgical Periodontal Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months
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 months
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.
3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr.K.Sai Priyanka

Collaborators

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2016

Primary Completion (Actual)

January 17, 2017

Study Completion (Actual)

February 19, 2017

Study Registration Dates

First Submitted

August 3, 2018

First Submitted That Met QC Criteria

August 7, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Actual)

August 13, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Panineeya Mahavidyalaya
  • D159206045 (Other Identifier: Dr.NTR University of Health Sciences)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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