Salivary Bacterial Profiles in Relation to Periodontal Treatment

NCT02913248 | Completed DMC

• 1 other identifier: UCPH_OI_001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

periodontitis; saliva; bacteria

Outcome Measures

Primary Outcomes (1)

• Changes in α-diversity in saliva samples collected .

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

  Baseline and 12 weeks

Secondary Outcomes (1)

• Specis specific changes in saliva samples collected

  Baseline and 12 weeks

Study Arms (1)

Conventional periodontal treatment

EXPERIMENTAL

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

Interventions

Conventional periodontal treatment PROCEDURE

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

Conventional periodontal treatment

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Manifest chronic periodontitis according to international classification

You may not qualify if:

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

Sponsors & Collaborators

• University of Copenhagen: lead
• The Forsyth Institute: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

University of Copenhagen, Department of Odontology

Copenhagen, Copenhagen, 2200, Denmark

Location

Related Publications (2)

• 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.

  PMID: 32681659 DERIVED

• 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.

  PMID: 31893018 DERIVED

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Daniel Belstrøm, DDS, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 23, 2016
• Study Start: October 1, 2016
• Primary Completion: January 2, 2017
• Study Completion: January 2, 2017
• Last Updated: February 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)