NCT02583841

Brief Summary

Aim: To evaluate effect of non- surgical periodontal therapy on liver function in systemically healthy chronic periodontitis (CP) subjects. Materials and methods: The study is non surgical interventional trial, includes 50 CP subjects in the age group of 35- 60 years selected from the OPD (Out Patient Department) of department of periodontology Tatyasaheb Kore Dental College and Research center (TKDC and RC), Kolhapur. CP subjects were equally divided into test group and control group. Liver function test- aspartate aminotransferase (AST), alanine aminotransferase (ALT) were checked at baseline and at 1 month after treatment. Clinical examination includes plaque index, gingival index, sulcus bleeding index, probing depth, clinical attachment loss.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_4

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

February 1, 2015

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed
Last Updated

October 22, 2015

Status Verified

October 1, 2015

Enrollment Period

28 days

First QC Date

October 17, 2015

Last Update Submit

October 21, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • Alanine aminotransferase

    1month

  • Aspartate aminotransferase

    1 month

Secondary Outcomes (5)

  • plaque index

    1month

  • gingival index

    1 month

  • sulcus bleeding index

    1month

  • probing depth

    1month

  • Clinical attachment loss

    1 month

Study Arms (2)

Scaling and Root Planing( SRP)

ACTIVE COMPARATOR

This was an interventional study in which scaling and root planing was done in systemically healthy patients with chronic periodontitis

Procedure: Scaling and root planing

Control Group

NO INTERVENTION

Scaling and root planing was not done , that is no intervention is carried out in the patients of this group.

Interventions

scaling and root planing as an intervention was done in patients of the test group

Scaling and Root Planing( SRP)

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects with CP (moderate and severe) as per Centers for disease control and prevention (CDC) criteria 2007.
  • Patients without any known systemic diseases

You may not qualify if:

  • Patients who have taken anti-inflammatory/antibiotic/antioxidant within 3 months of beginning of study.
  • Subjects who have undergone periodontal treatment within six months of inception of study.
  • Smokers, tobacco habits in any form and alcoholics.
  • Pregnant and lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post graduate student

Study Record Dates

First Submitted

October 17, 2015

First Posted

October 22, 2015

Study Start

February 1, 2015

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

October 22, 2015

Record last verified: 2015-10