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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02913248
Other study ID # UCPH_OI_001
Secondary ID
Status Completed
Phase N/A
First received September 20, 2016
Last updated February 2, 2017
Start date October 2016
Est. completion date January 2, 2017

Study information

Verified date February 2017
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 2, 2017
Est. primary completion date January 2, 2017
Accepts healthy volunteers No
Gender All
Age group 40 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Conventional periodontal treatment
Non-surgical periodontal treatment including thorough instruction in self-performed oral hygiene

Locations

Country Name City State
Denmark University of Copenhagen, Department of Odontology Copenhagen

Sponsors (3)

Lead Sponsor Collaborator
University of Copenhagen Rigshospitalet, Denmark, The Forsyth Institute

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in a-diversity in saliva samples collected . Comparison of a-diversity in saliva samples collected before periodontal treatment and 12 weeks after treatment Baseline and 12 weeks
Secondary 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 Baseline and 12 weeks
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