NCT06255470

Brief Summary

The present study aimed to determine the effect of non-surgical periodontal treatment on serum and salivary SIRT-1, MMP-9, and T-SOD levels in periodontitis stage III grade B (P-III-B) and C (P-III-C) patients. 17 periodontally healthy, 16 P-III-B and 16 P-III-C subjects 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 3 months after treatment. Serum and salivary SIRT-1, MMP-9, and T-SOD 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
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

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

September 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
Last Updated

February 13, 2024

Status Verified

January 1, 2024

Enrollment Period

1.2 years

First QC Date

February 4, 2024

Last Update Submit

February 4, 2024

Conditions

Periodontal HealthPeriodontitis

Keywords

periodontitisperiodontal treatment

Outcome Measures

Primary Outcomes (3)

  • Salivary SIRT-1 (ng/mL) level

    change in salivary SIRT-1 levels from baseline to 3 months after treatment

    baseline to 3 months after treatment

  • Salivary MMP-9 (ng/mL) level

    change in salivary MMP-9 levels from baseline to 3 months after treatment

    baseline to 3 months after treatment

  • Salivary T-SOD (U/mL) level

    change in salivary T-SOD levels from baseline to 3 months after treatment

    baseline to 3 months after treatment

Secondary Outcomes (3)

  • Serum SIRT-1 (ng/mL) level

    baseline to 3 months after treatment

  • Serum MMP-9 (ng/mL) level

    baseline to 3 months after treatment

  • Serum T-SOD (U/mL) level

    baseline to 3 months after treatment

Study Arms (3)

Periodontally Healthy

NO INTERVENTION

Periodontally healthy patients received no intervention.

Periodontitis Stage III Grade B

ACTIVE COMPARATOR

The patients were subjected to quadrant-wise full-mouth subgingival scaling and root planning under local anesthesia by the use of ultrasonic scalers and curettes. 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

Periodontitis Stage III Grade C

ACTIVE COMPARATOR

The patients were subjected to quadrant-wise full-mouth subgingival scaling and root planning under local anesthesia by the use of ultrasonic scalers and curettes. 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

Non-surgical periodontal treatment involves the removal of microbial dental plaque and calculus by mechanical debridement using manual and ultrasonic instruments. Motivating and educating patients about oral hygiene procedures is another important part of the treatment. The aim is to stop the progression of the disease and to prevent the occurrence of active clinical inflammation.

Periodontitis Stage III Grade BPeriodontitis Stage III Grade C

Eligibility Criteria

Age23 Years - 50 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, periodontitis stage III grade B and C diagnoses

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

Related Publications (1)

  • Iyigun S, Gorgulu NG, Dogan B. Changes in MMP-9, T-SOD and SIRT-1 levels after non-surgical periodontal treatment. BMC Oral Health. 2025 Feb 19;25(1):262. doi: 10.1186/s12903-025-05610-5.

    PMID: 39972299DERIVED

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

February 4, 2024

First Posted

February 13, 2024

Study Start

September 1, 2022

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

February 13, 2024

Record last verified: 2024-01

Locations

TU(1)