Effect of Periodontal Therapy on Biomarkers in Periodontitis

NCT05005923 | Completed

• 1 other identifier: SAG-A-230119-0014
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aimed to assess the effect of non-surgical periodontal treatment on serum and salivary MMP-8, MAF, MIP-1α, M-CSF, and IL34 levels in periodontitis stage III grade B (P-III-B) and C (P-III-C) patients. 20 periodontally healthy, 20 P-III-B and 25 P-III-C 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 MMP-8, MAF, MIP-1α, M-CSF, and IL34 levels were analyzed by ELISA. Data were analyzed using appropriate statistical tests.

Conditions

Periodontal Health; Periodontitis

Keywords

periodontitis; periodontal treatment

Outcome Measures

Primary Outcomes (5)

• Salivary MMP-8 (ng/ml) level

  change in salivary MMP-8 levels from baseline to 1 month and 3 months after treatment

  baseline to 1 month and 3 months after treatment

• Salivary MAF (ng/ml) level

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

  baseline to 1 month and 3 months after treatment

• Salivary MIP-1α (pg/ml) level

  change in salivary MIP-1α levels from baseline to 1 month and 3 months after treatment

  baseline to 1 month and 3 months after treatment

• Salivary M-CSF (pg/ml) level

  change in salivary M-CSF levels from baseline to 1 month and 3 months after treatment

  baseline to 1 month and 3 months after treatment

• Salivary IL-34 (pg/ml) level

  change in salivary M-CSF levels from baseline to 1 month and 3 months after treatment

  baseline to 1 month and 3 months after treatment

Secondary Outcomes (5)

• Serum MMP-8 (ng/ml) level

  baseline to 1 month and 3 months after treatment

• Serum MAF /ng/ml) level

  baseline to 1 month and 3 months after treatment

• Serum MIP-1α (pg/ml) level

  baseline to 1 month and 3 months after treatment

• Serum M-CSF (pg/ml) level

  baseline to 1 month and 3 months after treatment

• Serum IL-34 (pg/ml) level

  baseline to 1 month and 3 months after treatment

Study Arms (3)

Periodontal healthy

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. 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 Stage III Grade 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

Interventions

Non-surgically performed scaling and root planing PROCEDURE

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

Periodontitis Stage III Grade B; Periodontitis Stage III Grade C

Eligibility Criteria

• Age: 23 Years - 51 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University, Faculty of Dentistry, Department of Periodontology

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

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: July 29, 2021
• First Posted: August 16, 2021
• Study Start: January 23, 2019
• Primary Completion: July 24, 2020
• Study Completion: July 24, 2020
• Last Updated: August 16, 2021

Record last verified: 2021-08

Locations

TU (1)