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Salivary Bacterial Profiles in Relation to Periodontal Treatment

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Conventional periodontal treatment
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Periodontitis focused on measuring periodontitis, saliva, bacteria

Eligibility Criteria

40 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Copenhagen, Department of Odontology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Conventional periodontal treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Changes in α-diversity in saliva samples collected .
Comparison of α-diversity in saliva samples collected before periodontal treatment and 12 weeks after treatment

Secondary Outcome Measures

Specis specific changes in saliva samples collected
Comparison of relative abundance of bacterial species in saliva samples collected before periodontal treatment to samples collected 12 weeks after treatment

Full Information

First Posted
September 20, 2016
Last Updated
February 2, 2017
Sponsor
University of Copenhagen
Collaborators
The Forsyth Institute, Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02913248
Brief Title
Salivary Bacterial Profiles in Relation to Periodontal Treatment
Official Title
Short and Long Term Alterations of Subgingival and Salivary Microbiota in Relation to Periodontal Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
January 2, 2017 (Actual)
Study Completion Date
January 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
The Forsyth Institute, Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
periodontitis, saliva, bacteria

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional periodontal treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional periodontal treatment
Intervention Description
Non-surgical periodontal treatment including thorough instruction in self-performed oral hygiene
Primary Outcome Measure Information:
Title
Changes in α-diversity in saliva samples collected .
Description
Comparison of α-diversity in saliva samples collected before periodontal treatment and 12 weeks after treatment
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Specis specific changes in saliva samples collected
Description
Comparison of relative abundance of bacterial species in saliva samples collected before periodontal treatment to samples collected 12 weeks after treatment
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Belstrøm, DDS, PhD
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Copenhagen, Department of Odontology
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All individual participant data will be handled anonymously
Citations:
PubMed Identifier
32681659
Citation
Grande MA, Belstrom D, Damgaard C, Holmstrup P, Thangaraj SS, Nielsen CH, Palarasah Y. Complement split product C3c in saliva as biomarker for periodontitis and response to periodontal treatment. J Periodontal Res. 2021 Jan;56(1):27-33. doi: 10.1111/jre.12788. Epub 2020 Jul 18.
Results Reference
derived
PubMed Identifier
31893018
Citation
Grande MA, Belstrom D, Damgaard C, Holmstrup P, Kononen E, Gursoy M, Gursoy UK. Salivary concentrations of macrophage activation-related chemokines are influenced by non-surgical periodontal treatment: a 12-week follow-up study. J Oral Microbiol. 2019 Dec 9;12(1):1694383. doi: 10.1080/20002297.2019.1694383. eCollection 2020.
Results Reference
derived

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Salivary Bacterial Profiles in Relation to Periodontal Treatment

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