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Salivary Bacterial Profiles in Relation to Periodontal Treatment

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ClinicalTrials.gov Identifier: NCT02913248
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : February 3, 2017
Sponsor:
Collaborators:
The Forsyth Institute
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Daniel Belstrøm, DDS, PhD, University of Copenhagen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Periodontitis Procedure: Conventional periodontal treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Short and Long Term Alterations of Subgingival and Salivary Microbiota in Relation to Periodontal Treatment
Study Start Date : October 2016
Actual Primary Completion Date : January 2, 2017
Actual Study Completion Date : January 2, 2017

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   40 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913248


Locations
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Denmark
University of Copenhagen, Department of Odontology
Copenhagen, Denmark, 2200
Sponsors and Collaborators
University of Copenhagen
The Forsyth Institute
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Daniel Belstrøm, DDS, PhD University of Copenhagen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniel Belstrøm, DDS, PhD, Assistant professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02913248    
Other Study ID Numbers: UCPH_OI_001
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data will be handled anonymously
Keywords provided by Daniel Belstrøm, DDS, PhD, University of Copenhagen:
periodontitis
saliva
bacteria
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases