Salivary Bacterial Profiles in Relation to Periodontal Treatment

February 2, 2017 updated by: Daniel Belstrøm, DDS, PhD, University of Copenhagen

Short and Long Term Alterations of Subgingival and Salivary Microbiota in Relation to Periodontal Treatment

The purpose of the present investigation is to record and compare bacterial compositions in subgingival plaque samples and saliva samples in subjects receiving periodontal treatment. The hypothesis is that the composition of the salivary microbiota might reflect local bacterial alterations in relation to periodontal treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study we plan to enroll 35 subjects with manifest periodontitis, which will be treated according to national and international guidelines. Clinical registration and collection of subgingival plaque samples and saliva samples will be performed at baseline and 2, 6 and 12 weeks after treatment.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2200
        • University of Copenhagen, Department of Odontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Manifest chronic periodontitis according to international classification

Exclusion Criteria:

  • Other treatment requiring oral conditions
  • Systemic antibiotics within the latest 6 months
  • Systemic diseases and medications with known associations to periodontitis
  • Pregnancy and breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional periodontal treatment
35 subjects diagnosed with manifest periodontitis, which will all receive standardized treatment according to protocol. In brief, this treatment includes professional tooth cleaning and thorough instruction in self-performed oral hygiene procedures. Clinical registrations and collection of microbiological samples (subgingival and saliva) will performed at baseline and 2, 6 and 12 weeks after treatment.
Procedure: Conventional periodontal treatment
Non-surgical periodontal treatment including thorough instruction in self-performed oral hygiene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in α-diversity in saliva samples collected .
Time Frame: Baseline and 12 weeks
Comparison of α-diversity in saliva samples collected before periodontal treatment and 12 weeks after treatment
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specis specific changes in saliva samples collected
Time Frame: Baseline and 12 weeks
Comparison of relative abundance of bacterial species in saliva samples collected before periodontal treatment to samples collected 12 weeks after treatment
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Rigshospitalet, Denmark
The Forsyth Institute

Investigators

  • Principal Investigator: Daniel Belstrøm, DDS, PhD, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

January 2, 2017

Study Completion (Actual)

January 2, 2017

Study Registration Dates

First Submitted

September 20, 2016

First Submitted That Met QC Criteria

September 22, 2016

First Posted (Estimate)

September 23, 2016

Study Record Updates

Last Update Posted (Estimate)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCPH_OI_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All individual participant data will be handled anonymously

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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