Clinical trial NCT03620396: Comparison of Serum Trefoil Factor 3 in Patients With Gingivitis and Periodontitis After Scaling and Root Planing
Official title: Comparison of Serum Levels of Trefoil Factor 3 in Patients With Gingivitis and Periodontitis Following Non Surgical Periodontal Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis and Periodontal Diseases
Lead sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Sponsor class: OTHER
Collaborators: name: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
First posted: 2018-08-08
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Trefoil factor 3
timeFrame: 3 months.
Secondary outcomes:
measure: Change in the Gingival Index.
timeFrame: 3 months
measure: Change in Modified Plaque Index
timeFrame: 3 months
measure: Change in Probing depth
timeFrame: 3 months
measure: Change in Clinical Attachment loss
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
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.