NCT05262153

Brief Summary

The present study aimed to assess the effect of smoking on non-surgical periodontal treatment on serum and salivary RANKL, OPG and IL34 levels in periodontitis stage III grade C (P-III-C) patients. 20 periodontally healthy, 20 P-III-C and 20 P-III-C with smoking (P-III-CS) participants were enrolled. At baseline, serum and saliva samples were collected and the whole mouth clinical periodontal parameters were recorded. Periodontitis patients received non-surgical periodontal treatment. Clinical parameters were re-measured and samples were re-collected at 1 and 3 months after treatment. Serum and salivary RANKL, OPG and IL34 levels 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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

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

January 25, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

1.6 years

First QC Date

February 21, 2022

Last Update Submit

March 1, 2022

Conditions

Periodontal DiseasesSmoking

Keywords

PeriodontitisSmokingPeriodontal treatment

Outcome Measures

Primary Outcomes (7)

  • Salivary IL-34 (pg/ml) level

    change in salivary IL-34 levels from baseline to 1 month and 3 months after treatment

    baseline to 1 month and 3 months after treatment

  • Salivary OPG (pg/ml) level

    change in salivary OPG levels from baseline to 1 month and 3 months after treatment

    baseline to 1 month and 3 months after treatment

  • Salivary RANKL (pg/ml) level

    change in salivary RANKL levels from baseline to 1 month and 3 months after treatment

    baseline to 1 month and 3 months after treatment

  • Serum IL-34 (pg/ml) level

    change in serum IL-34 levels from baseline to 1 month and 3 months after treatment

    baseline to 1 month and 3 months after treatment

  • Serum OPG (pg/ml) level

    change in serum OPG levels from baseline to 1 month and 3 months after treatment

    baseline to 1 month and 3 months after treatment

  • Serum RANKL (pg/ml) level

    change in serum RANKL levels from baseline to 1 month and 3 months after treatment

    baseline to 1 month and 3 months after treatment

  • Sites initially PD≥5mm

    PD reduction in sites initially PD≥5mm

    baseline to 1 month and 3 months after treatment

Study Arms (3)

Periodontally healthy

NO INTERVENTION

Periodontitis III-C

ACTIVE COMPARATOR

The patients were subjected to quadrant-wise full-mouth subgingival scaling and root planning 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-surgically performed scaling and root planing

Periodontitis III-C Smoking

ACTIVE COMPARATOR

The patients were subjected to quadrant-wise full-mouth subgingival scaling and root planning 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-surgically performed scaling and root planing

Interventions

Non-surgically performed scaling and root planingPROCEDURE

Treatment of patients with periodontitis was performed using manual and ultrasonic instruments.

Periodontitis III-CPeriodontitis III-C Smoking

Eligibility Criteria

Age24 Years - 56 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • systemically healthy individuals
  • having ≥20 teeth present (except third molars)
  • individuals with periodontally healthy, periodontitis stage III grade C diagnoses
  • Smokers were smoking 10 cigarettes per day more than 5 years while non-smokers were never smoked.

You may not qualify if:

  • having any diagnosed medical disorders such as diabetes mellitus, cardiovascular diseases, rheumatoid arthritis, immunological and mucocutaneous diseases
  • usage of antibiotics, non-steroidal anti-inflammatory drugs and immunosuppressive agents within the past 6 months
  • having any non-inflammatory destructive periodontal disease
  • nonsurgical/surgical periodontal therapy received in the past year
  • pregnant/ lactating/ postmenopausal females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University, Faculty of Dentistry, Department of Periodontology

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal DiseasesSmokingPeriodontitis

Interventions

Root Planing

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Dental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Design

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

Study Record Dates

First Submitted

February 21, 2022

First Posted

March 2, 2022

Study Start

January 25, 2019

Primary Completion

September 15, 2020

Study Completion

September 15, 2020

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations

TU(1)