NCT03620396

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

August 3, 2018

Last Update Submit

August 9, 2018

Conditions

Gingivitis and Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in the Gingival Index.

    3 months

  • Change in Modified Plaque Index

    3 months

  • Change in Probing depth

    3 months

  • Change in Clinical Attachment loss

    3 months

Study Arms (2)

Experimental: Interventional

EXPERIMENTAL

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.

Procedure: Scaling and root planing

Experimental Interventional

EXPERIMENTAL

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.

Procedure: Scaling and root planing

Interventions

Scaling and root planingPROCEDURE

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

Experimental InterventionalExperimental: Interventional

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 22181686BACKGROUND

  • 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.

    PMID: 20121925BACKGROUND

MeSH Terms

Conditions

GingivitisPeriodontal Diseases

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

August 3, 2018

First Posted

August 8, 2018

Study Start

October 15, 2016

Primary Completion

January 17, 2017

Study Completion

February 19, 2017

Last Updated

August 13, 2018

Record last verified: 2018-08