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

Gingivitis and Periodontal Diseases Clinical Trial

— CSTF3PGPSR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620396
• Other study ID #: Panineeya Mahavidyalaya
• Secondary ID: D159206045
• Status: Completed
• Phase: N/A
• Start date: October 15, 2016
• Est. completion date: February 19, 2017

Study information

• Verified date: August 2018
• Source: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 19, 2017
• Est. primary completion date: January 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Diseases
• Gingivitis
• Gingivitis and Periodontal Diseases
• Periodontal Diseases
• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Dr.K.Sai Priyanka	Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months.
Secondary	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	3 months
Secondary	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	3 months
Secondary	Change in Probing depth	The distance from the gingival margin to the depth of the pocket is measured using Williams periodontal probe.	3 months
Secondary	Change in Clinical Attachment loss	The distance from the cementoenamel junction to the tip of the alveolar crest is measures using Williams periodontal probe.	3 months