NCT05395455

Brief Summary

The present study aimed to assess the effect of non-surgical periodontal treatment on gingival crevicular fluid (GCF), saliva, and serum IL-26, IL-6, and IL-10 levels in stage III grade B periodontitis (SIII-GB-P) and C periodontitis (SIII-GC-P) patients. 25 periodontally healthy, 25 SIII-GB-P, and 25 SIII-GC-P participants were enrolled. At baseline, GCF, saliva, and serum samples were collected and the whole mouth clinical periodontal parameters were recorded. Periodontitis patients received non-surgical periodontal treatment (NSPT). Clinical parameters and samples were re-collected at 1 and 3 months after NSPT. GCF, saliva, and serum IL-26, IL-6, and IL-10 were analyzed by ELISA. Data were analyzed using appropriate statistical tests.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2020

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

1.2 years

First QC Date

May 24, 2022

Last Update Submit

May 24, 2022

Conditions

Periodontal HealthPeriodontitis

Keywords

periodontitisperiodontal treatment

Outcome Measures

Primary Outcomes (3)

  • GCF IL-26 level (ng/ml)

    Change in GCF IL-26 levels from baseline to 1 month and 3 months after treatment

    Baseline to 1 month and 3 months after treatment

  • GCF IL-6 level (ng/ml)

    Change in GCF IL-6 levels from baseline to 1 month and 3 months after treatment

    Baseline to 1 month and 3 months after treatment

  • GCF IL-10 level (ng/ml)

    Change in GCF IL-10 levels from baseline to 1 month and 3 months after treatment

    Baseline to 1 month and 3 months after treatment

Secondary Outcomes (6)

  • Saliva IL-26 level (ng/ml)

    Baseline to 1 month and 3 months after treatment

  • Saliva IL-6 level (ng/ml)

    Baseline to 1 month and 3 months after treatment

  • Saliva IL-10 level (ng/ml)

    Baseline to 1 month and 3 months after treatment

  • Serum IL-26 level (ng/ml)

    Baseline to 1 month and 3 months after treatment

  • Serum IL-6 level (ng/ml)

    Baseline to 1 month and 3 months after treatment

  • +1 more secondary outcomes

Study Arms (3)

Periodontally Healthy

NO INTERVENTION

Systemically and periodontally healthy

Stage III Grade B Periodontitis

ACTIVE COMPARATOR

The patients were subjected to quadrant-wise full-mouth subgingival scaling and root planing under local anesthesia. The entire non-surgical periodontal treatment of periodontitis groups was completed in a total of 4 sessions in two weeks.

Procedure: Non-surgical periodontal treatment

Stage III Grade C Periodontitis

ACTIVE COMPARATOR

The patients were subjected to quadrant-wise full-mouth subgingival scaling and root planing under local anesthesia. The entire non-surgical periodontal treatment of periodontitis groups was completed in a total of 4 sessions in two weeks.

Procedure: Non-surgical periodontal treatment

Interventions

Non-surgical periodontal treatmentPROCEDURE

Treatment of patients with periodontitis was performed scaling and root planing by using manual and ultrasonic instruments.

Stage III Grade B PeriodontitisStage III Grade C Periodontitis

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • systemically healthy and non-smoker individuals
  • having ≥20 teeth present (except third molars)
  • individuals with periodontally healthy, stage III grade B and C periodontitis diagnoses

You may not qualify if:

  • having any diagnosed medical disorders
  • usage of antibiotics, non-steroidal anti-inflammatory drugs, and immunosuppressive agents within the past 6 months
  • having any non-inflammatory destructive periodontal disease
  • non-surgical/surgical periodontal therapy received in the past year
  • pregnant/ lactating/ postmenopausal females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatice Selin Yıldırım

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2022

First Posted

May 27, 2022

Study Start

November 12, 2018

Primary Completion

January 23, 2020

Study Completion

January 23, 2020

Last Updated

May 27, 2022

Record last verified: 2022-05

Locations

TU(1)