Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03620396
Acronym
CSTF3PGPSR
Enrollment
40
Registered
2018-08-08
Start date
2016-10-15
Completion date
2017-02-19
Last updated
2018-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis and Periodontal Diseases

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.

Interventions

PROCEDUREScaling 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.

Sponsors

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
CollaboratorOTHER
Dr.K.Sai Priyanka
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Trefoil factor 33 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

MeasureTime frameDescription
Change in the Gingival Index.3 monthsThe 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 Index3 monthsExamination 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 depth3 monthsThe distance from the gingival margin to the depth of the pocket is measured using Williams periodontal probe.
Change in Clinical Attachment loss3 monthsThe distance from the cementoenamel junction to the tip of the alveolar crest is measures using Williams periodontal probe.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026