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Completed

NCT Number: NCT06715176

TREM-1 Pathway in Predicting Treatment Outcomes in Periodontitis

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.

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Key information

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Aydin, 90100, Turkey (Türkiye)

About this study

Study population and design: For this 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 recruited at the Department of Periodontology, School of Dentistry, Aydın Adnan Menderes University, Aydın, Turkey.

Clinical examination and saliva collection: All participants were clinically examined at baseline (T0) and whole mouth plaque (PI) and gingival index (GI), probing depth (PD), bleeding on probing (BOP) and clinical attachment loss (CAL) were measured. Prior to clinical examinations, unstimulated whole saliva was collected from all participants at baseline (T0). Additionally, saliva sampling and clinical examinations were performed for all periodontitis patients (grade B and C) one (T1), three (T3) and six (T6) months after non-surgical periodontal treatment.

Non-surgical periodontal treatment protocol: The patients underwent non-surgical periodontal therapy including quadrant-based scaling and root planning (SRP) using ultrasonic instruments and periodontal curettes until the root surfaces were visibly and tactically clean and smooth. All participants were given routine oral hygiene instructions and asked to abstain from any anti-inflammatory drugs, antibiotics, or mouthwashes containing chlorhexidine throughout the study period. At every visit, oral hygiene instructions were reinforced, and the sites that did not respond to treatment at T1 underwent additional re-instrumentation at T3 and T6. While non-surgical treatment efficacy is often reported in terms of mean values of PD reduction and CAL gain, these metrics may not fully capture treatment success or periodontal stability.

Triggering receptor expressed on myeloid cells (TREM)-1, peptidoglycan recognition protein 1 (PGLYRP1) and interleukin (IL)-1β immunoassays and total protein determination: 249 saliva samples were included for the analysis of TREM-1, PGLYRP1 and IL-1β. Levels of those cytokines in saliva were measured by commercial enzyme-linked immunosorbent assays according to manufacturer's instructions. Total protein levels in saliva were measured by the BCA Protein Assay according to the manufacturer's guidelines.

Statistical analysis: Group comparisons were performed with Mann-Whitney, Kruskal-Wallis with Dunn-Bonferroni post-hoc, or Chi-square tests, whenever appropriate. Group comparisons before and after treatment were performed with Friedman with Dunn-Bonferroni post-hoc test. Differences were deemed statistically significant at p ≤0.05.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • systemically healthy
  • non-smoker individuals

Exclusion criteria

  • 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.

Treatment and study plan

Clinical periodontal measurements at baseline (T0)

Other

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.

Saliva collection at baseline (T0)

Other

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.

Scaling and root planing

Other

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.

Clinical periodontal measurements at T1, T3, and T6.

Other

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.

Saliva collection at T1, T3, and T6.

Other

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.

Primary outcomes

  1. Salivary TREM-1 level

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

    Salivary TREM-1 concentration (pg/ml)

  2. Salivary PGLYRP1 level

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

    Salivary PGLYRP1 concentration (ng/ml)

  3. Salivary IL-1β level

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

    Salivary IL-1β concentration (pg/ml)

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

Prognostic Utility of TREM-1 Pathway in Predicting Treatment Outcomes in Patients With Grades B and C Periodontitis

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Dec 4, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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