NCT05952895

Brief Summary

This study aims to investigate salivary proteome changes in periodontitis patients before and after non-surgical treatment. Ten systemically healthy and non-smoker individuals with stage III, grade C periodontitis underwent non-surgical periodontal treatment. Saliva was collected at baseline, and one and six months post-treatment. Whole-mouth plaque and gingival index, probing depth, bleeding on probing and clinical attachment loss were measured. The saliva proteome was investigated by label-free quantitative proteomics. Normalized protein intensities were measured and protein changes were modeled over time with significant protein regulation considered at false discovery rate (FDR)\<0.05.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

12 months

First QC Date

July 6, 2023

Last Update Submit

July 18, 2023

Conditions

Keywords

PeriodontitisSalivaProteome

Outcome Measures

Primary Outcomes (1)

  • Saliva protein content change

    pg/ml

    Change from baseline to 1 month and 6 months after treatment

Study Arms (1)

Stage III, Grade C Periodontitis

Conventional quadrant-wise scaling and root planing (SRP)

Procedure: Conventional quadrant-wise scaling and root planing (SRP)

Interventions

SRP was conducted at baseline, after saliva collection and periodontal assessment, starting with the upper right quadrant and continuing clockwise over four visits at weekly intervals. SRP was performed under local anesthesia by the same periodontist (B.A.) by use of ultrasonic instruments (Mini Piezon, EMS, Nyon, CH) and manual periodontal curettes (Gracey curets, scaler Hu-Friedy, Chicago, IL). All present teeth were instrumented until the root surface was visually and tactilely clean and smooth. Self-performed plaque control measures consisted of toothbrushing using the modified Bass technique with a medium toothbrush and a regular toothpaste with fluoride twice a day and interdental cleaning using dental floss and/or interdental brushes once a day.

Stage III, Grade C Periodontitis

Eligibility Criteria

Age32 Years - 43 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

A total of 10 systemically healthy and non-smoker individuals with stage III, grade C periodontitis (5 males/5 females; aged 32 to 43 years) were consecutively included.

You may qualify if:

  • Non-smokers
  • Having at least 20 natural teeth.

You may not qualify if:

  • Having any chronic inflammatory or immunological conditions such as diabetes mellitus, cardiovascular diseases, rheumatoid arthritis and mucocutaneous diseases,
  • Pregnant or lactating
  • Intake of antimicrobials, anti-inflammatory drugs and immunosuppressive agents within the last 6 months
  • Non-surgical/surgical periodontal therapy within 12 months
  • Having orthodontic appliances, removable partial dentures and restorative and endodontic treatment requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adnan Menderes University, Faculty of Dentistry, Department of Periodontology

Aydin, 09100, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Unstimulated whole saliva

MeSH Terms

Conditions

Periodontitis

Interventions

Root Planing

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • Angelika Silbereisen

    Department of Dental Medicine, Karolinska Institutet, Stockholm, Sweden

    PRINCIPAL INVESTIGATOR
  • Kai Bao

    Department of Dental Medicine, Karolinska Institutet, Stockholm, Sweden

    PRINCIPAL INVESTIGATOR
  • Witold Wolski

    Functional Genomics Center Zurich, ETH Zurich and University of Zurich, Switzerland

    PRINCIPAL INVESTIGATOR
  • Paolo Nanni

    Functional Genomics Center Zurich, ETH Zurich and University of Zurich, Switzerland

    PRINCIPAL INVESTIGATOR
  • Laura Kunz

    Functional Genomics Center Zurich, ETH Zurich and University of Zurich, Switzerland

    PRINCIPAL INVESTIGATOR
  • Beral Afacan

    Department of Periodontology, Faculty of Dentistry, Adnan Menderes University, Aydın, Turkey

    PRINCIPAL INVESTIGATOR
  • Gülnur Emingil

    Department of Periodontology, School of Dentistry, Ege University, İzmir, Turkey

    PRINCIPAL INVESTIGATOR
  • Nagihan Bostanci

    Department of Dental Medicine, Karolinska Institutet, Stockholm, Sweden

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 19, 2023

Study Start

July 1, 2018

Primary Completion

June 30, 2019

Study Completion

December 30, 2019

Last Updated

July 19, 2023

Record last verified: 2023-07

Locations