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Clinical Trials/NCT05952895
NCT05952895CompletedNot Applicable

Probing the Salivary Proteome for Prognostic Biomarkers in Response to Non-Surgical Management of Periodontitis

Aydin Adnan Menderes University1 site in 1 country10 target enrollmentStarted: July 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
10
Locations
1
Primary Endpoint
Saliva protein content change

Study Overview

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.

Detailed Description

Study Population and Clinical Examination

A total of 10 systemically healthy and non-smoker individuals with stage III, grade C periodontitis were recruited at the Department of Periodontology, School of Dentistry, Aydın Adnan Menderes University, Aydın, Turkey.

Full-mouth periodontal assessment included measurements of probing depth, clinical attachment loss, the percentage of sites with bleeding on probing, gingival index, and plaque index at baseline (T0) and one month (T1) and six months (T6) post-treatment. All measurements were obtained from 6 sites per tooth excluding third molars using a manual periodontal probe (William's periodontal probe, Hu-Friedy, Chicago, IL). The alveolar bone resorption was assessed on the digital panoramic radiograph in each participant. All clinical measurements were performed by an experienced periodontist (B.A.).

Diagnosis of stage III, grade C periodontitis was performed according to the criteria proposed by the 2017 International Workshop on the Classification of Periodontal and Peri-implant Diseases and Conditions.

Treatment

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
32 Years to 43 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Saliva protein content change

Time Frame: Change from baseline to 1 month and 6 months after treatment

pg/ml

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Aydin Adnan Menderes University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Beral Afacan

Principal Investigator

Aydin Adnan Menderes University

Study Sites (1)

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