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

Not Applicable

Completed

• Conditions: Gingivitis and Periodontal Diseases
• Interventions: Procedure: Scaling and root planing

• Registration Number: NCT03620396
• Lead Sponsor: Dr.K.Sai Priyanka

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 Timeline

• Study Start: 2016-10-15
• Primary Completion: 2017-01-17
• Study Completion: 2017-02-19
• Status Verified: 2018-08
• Study First Submitted: 2018-08-03
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Interventional	Scaling and root planing	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.
Experimental: Interventional	Scaling and root planing	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.

Primary Outcome Measures

Name	Time	Method
Trefoil factor 3	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

Name	Time	Method
Change in the Gingival Index.	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 Clinical Attachment loss	3 months	The distance from the cementoenamel junction to the tip of the alveolar crest is measures using Williams periodontal probe.
Change in Modified Plaque Index	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	3 months	The distance from the gingival margin to the depth of the pocket is measured using Williams periodontal probe.