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NCT Number: NCT03620396

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

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.

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Key information

Conditions

Gingivitis and Periodontal Diseases Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scaling and Root Planing

Procedure

After the serum collection is done from the patient for the assessment of trefoil factor 3, Non surgical periodontal therapy is carried out.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Dr.K.Sai Priyanka

Other

Collaborators

  • Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Registry information

Official study title

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

Acronym: CSTF3PGPSR

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 8, 2018
Registry last updated
Aug 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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