NCT06715176

Brief Summary

This study investigated modulations in salivary triggering receptor expressed on myeloid cells (TREM)-1, peptidoglycan recognition protein 1 (PGLYRP1) and interleukin (IL)-1β levels between healthy, gingivitis and periodontitis patients, and in response to non-surgical periodontal treatment. Systemically healthy, non-smokers with gingivitis (n=31), stage III periodontitis (grade B: n=34, grade C: n=24) and periodontally-healthy controls (n=34) were recruited. Periodontitis patients (n=45) underwent non-surgical periodontal treatment. Saliva was collected at baseline (T0, all groups), and three times (T1, T3 and T6) post-treatment (periodontitis groups only). Salivary biomarkers and total protein were measured using commercial assays.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2018

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2019

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

November 28, 2024

Last Update Submit

December 3, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Salivary TREM-1 level

    Salivary TREM-1 concentration (pg/ml)

    Change from baseline to one, three and six months after scaling and root planing

  • Salivary PGLYRP1 level

    Salivary PGLYRP1 concentration (ng/ml)

    Change from baseline to one, three and six months after scaling and root planing

  • Salivary IL-1β level

    Salivary IL-1β concentration (pg/ml)

    Change from baseline to one, three and six months after scaling and root planing

Study Arms (4)

Periodontal Health

This group showed PD ≤ 3 mm with BOP \< 10 % in the entire mouth as well as no interproximal CAL or radiographic bone loss.

Other: Clinical periodontal measurements at baseline (T0)Other: Saliva collection at baseline (T0)

Gingivitis

This group exhibited PD ≤ 3 mm with BOP ≥ 30 % in the entire mouth as well as no interproximal CAL or radiographic bone loss.

Other: Clinical periodontal measurements at baseline (T0)Other: Saliva collection at baseline (T0)

Stage III, Grade B Periodontitis

This group had interproximal CAL ≥ 5 mm along with PD ≥ 6 mm and radiographic bone loss extending to the middle or apical third of the root radiographically at 30 % of the teeth or more. CAL was not caused by trauma-related gingival recession, dental caries extending into the cervical areas of the teeth, endodontic lesions draining through the marginal periodontium, and the distal bone loss in adjacent second molars due to extractions of third molars. They had ≤ 4 teeth lost owing to periodontitis. % of radiographic bone loss/age value was between 0.25 and 1.0.

Other: Clinical periodontal measurements at baseline (T0)Other: Saliva collection at baseline (T0)Other: Scaling and root planingOther: Clinical periodontal measurements at T1, T3, and T6.Other: Saliva collection at T1, T3, and T6.

Stage III, Grade C Periodontitis

This group had interproximal CAL ≥ 5 mm along with PD ≥ 6 mm and radiographic bone loss extending to the middle or apical third of the root radiographically at 30 % of the teeth or more. CAL was not caused by trauma-related gingival recession, dental caries extending into the cervical areas of the teeth, endodontic lesions draining through the marginal periodontium, and the distal bone loss in adjacent second molars due to extractions of third molars. They had ≤ 4 teeth lost owing to periodontitis. % of radiographic bone loss/age were value was higher than 1.0.

Other: Clinical periodontal measurements at baseline (T0)Other: Saliva collection at baseline (T0)Other: Scaling and root planingOther: Clinical periodontal measurements at T1, T3, and T6.Other: Saliva collection at T1, T3, and T6.

Interventions

Full-mouth clinical periodontal measurements, including PD, CAL, GI, and PI were recorded at 6 sites per tooth, except the third molars, at baseline (T0). A manual periodontal probe was used for PD (millimeters) and CAL (millimeters) measurements; the cemento-enamel junction was used as a reference point for the measurement of CAL.

GingivitisPeriodontal HealthStage III, Grade B PeriodontitisStage III, Grade C Periodontitis

Unstimulated whole saliva was collected from all participants at baseline (T0). The participants were instructed to refrain from mechanical or chemical oral hygiene practices, eating, drinking, and chewing gum for 2 hours prior to sample collection. Every participant rinsed the mouth with tap water for 2 minutes. Ten minutes after rinsing, they were told to allow the accumulation of the saliva in their mouths and then to drain passively the saliva pool from the lower lip into a steril container for 5 minutes.

GingivitisPeriodontal HealthStage III, Grade B PeriodontitisStage III, Grade C Periodontitis

Periodontitis patients (grade B and C) underwent a program of non-surgical periodontal therapy consisting of conventional quadrant-based scaling and root planing using ultrasonic instruments and manual periodontal curette over four visits at 1-week intervals. All present teeth were instrumented until the root surface was visually and tactilely clean and smooth. Patients who did not respond to treatment at baseline (T0) received a further round of scaling and root planing at three (T3) months post-therapy in order to eliminate residual pockets.

Stage III, Grade B PeriodontitisStage III, Grade C Periodontitis

Full-mouth clinical periodontal measurements were performed for all periodontitis patients (grade B and C) at one (T1), three (T3) and six (T6) months after scaling and root planing.

Stage III, Grade B PeriodontitisStage III, Grade C Periodontitis

Unstimulated whole saliva were collected from all periodontitis patients (grade B and C) at one (T1), three (T3) and six (T6) months after scaling and root planing.

Stage III, Grade B PeriodontitisStage III, Grade C Periodontitis

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

For this observational study, systemically healthy, non-smokers with gingivitis (n = 31), stage III, grade B periodontitis (n = 34), stage III, grade C periodontitis (n = 24), and periodontally healthy controls (n = 34) were consecutively recruited at the Department of Periodontology, School of Dentistry, Aydın Adnan Menderes University, Aydın, Turkey.

You may qualify if:

  • systemically healthy
  • non-smoker individuals

You may not qualify if:

  • pregnancies or lactation
  • to exposure to antibiotics or any other drugs that were known to affect periodontal conditions over the past 6 months prior to recruitment.
  • to receive previous surgical/nonsurgical periodontal treatment during the previous 12-months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Aydin, 90100, Turkey (Türkiye)

Location

Related Publications (1)

  • Silbereisen A, Lira-Junior R, Afacan B, Ozturk OV, Emingil G, Bostanci N. TREM-1 Pathway Biomarkers for Classification of Periodontal Diseases and Monitoring of Treatment Response in Grade B and C Periodontitis. J Clin Periodontol. 2025 Sep;52(9):1288-1297. doi: 10.1111/jcpe.14195. Epub 2025 Jun 17.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Unstimulated whole saliva

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Tooth ExfoliationRoot PlaningTriiodothyronine

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive DentistryThyroninesThyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsThyroxineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Nagihan Bostanci

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

November 28, 2024

First Posted

December 4, 2024

Study Start

December 19, 2016

Primary Completion

January 3, 2018

Study Completion

November 29, 2019

Last Updated

December 4, 2024

Record last verified: 2024-12

Locations