NCT06675474

Brief Summary

This study aimed to compare the microbiome and proteome profiles of saliva, serum and all periodontal sites in patients with periodontitis. Saliva, serum, gingival crevicular fluid and subgingival plaque were obtained from three patients with stage III, grade C periodontitis. Quantitative proteomics were performed for proteome analysis of saliva, serum and gingival crevicular fluid, whereas shotgun whole genome sequencing was performed for microbiome analysis in saliva, serum and plaque.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

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

December 4, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

November 4, 2024

Last Update Submit

November 4, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Host proteomics profiles from saliva, serum and GCF

    Concentrations

    24 hours after clinical periodontal measurements

  • Microbial profiles from subgingival plaque and saliva

    Linear discriminant analysis scores

    24 hours after clinical periodontal measurements

Study Arms (1)

Periodontitis

These patients had at least two interdental sites (at two non-adjacent teeth) with interproximal CAL ≥5 mm, along with PD ≥6 mm and RBL extending to the mid-third of the root or beyond. CAL was not originated from endodontic lesions draining through the marginal periodontium, dental caries extending into the cervical areas of the teeth, trauma-related gingival recession or distal bone loss in 2nd molars owing to extractions of 3rd molars. They had ≤4 teeth lost due to periodontitis.

Other: Clinical periodontal measurementsOther: Saliva samplingOther: Serum SamplingOther: GCF samplingOther: Subgingival plaque sampling

Interventions

Clinical periodontal measurements included PD, CAL, BOP (+/-), GI, and PI. Clinical recordings were performed at six points (mesiobuccal, buccal, distobuccal, mesiopalatal, palatal, and distopalatal) of all teeth, except the 3rd molars.

Periodontitis

The whole unstimulated saliva samples were collected. Each participant was asked first to rinse the mouth completely with tap water for 2 minutes, wait for 10 minutes. Then the participants were requested to let the saliva pool in their floor of the mouth and to allow the saliva to drain passively into a falcon tube, 5 minutes.

Periodontitis

5 ml of venous blood were taken from the antecubital vein by a standard venipuncture method.

Periodontitis

GCF was collected from the six sites (mesiobuccal, buccal, distobuccal, mesiopalatal, palatal, and distopalatal) per tooth, except the 3rd molars, via steril paper strips.

Periodontitis

Subgingival plaque was collected by inserting two standardized paper points (no:30) at six sites (mesiobuccal, buccal, distobuccal, mesiopalatal, palatal, and distopalatal) per tooth, except the 3rd molars.

Periodontitis

Eligibility Criteria

Age43 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

A total of three systemically healthy and non-smoking patients with stage III, grade C peridontitis (3 males; age range 43 to 60 years) were consecutively enrolled from the population seeking periodontal treatment for the first time at the Department of Periodontology, School of Dentistry, Aydın Adnan Menderes University, Aydın, Turkey, between December 2019 to February 2020.

You may qualify if:

  • No history of smoking
  • At least 24 natural teeth (excluding 3rd molars)

You may not qualify if:

  • Being diagnosed with diabetes mellitus, rheumatoid arthritis, cardiovascular system diseases, endocrine, immunologic, and mucocutaneous disorders
  • Use of antibiotics, antihypertensives immunosuppressive, anti-inflammatory drugs and topical antiseptic solutions within the past 6 months
  • Having periodontal treatment in the previous year
  • Wearing removable partial dentures or orthodontic appliances
  • Pregnant or nursing women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Aydin, 09100, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva, serum, gingival crevicular fluid and subgingival plaque

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Nagihan Bostanci

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

November 4, 2024

First Posted

November 5, 2024

Study Start

December 4, 2019

Primary Completion

February 12, 2020

Study Completion

May 15, 2020

Last Updated

November 5, 2024

Record last verified: 2024-11

Locations