Effect of Periodontal Treatment on Inflammasome Proteins in Periodontal Diseases

NCT06075680 | Unknown

• 1 other identifier: TDK-2022-10763
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aimed to assess the effect of non-surgical periodontal treatment on serum and salivary IL-1beta, IL-18, NLRP3, ASC and Caspase-1 levels in gingivitis and Stage III Grade C periodontitis. 15 periodontally healthy, 15 gingivitis and 15 Stage III Grade C periodontitis patients were enrolled. At baseline, serum and saliva samples were collected and the whole mouth clinical periodontal parameters were recorded. Periodontitis and gingivitis 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 protein levels were analyzed by ELISA. Data were analyzed using appropriate statistical tests.

Conditions

Periodontal Diseases; Gingivitis; Periodontitis

Keywords

Periodontitis; Inflammasomes; Gingivitis

Outcome Measures

Primary Outcomes (5)

• Salivary NLRP3 levels (ng/ml)

  change in salivary NLRP3 levels from baseline to 1 month and 3 months after treatment

  from baseline to 1 month and 3 months after treatment

• Salivary ASC levels (pg/ml)

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

  from baseline to 1 month and 3 months after treatment

• Salivary Caspase-1 levels (ng/ml)

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

  from baseline to 1 month and 3 months after treatment

• Salivary IL-1beta levels (pg/ml)

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

  from baseline to 1 month and 3 months after treatment

• Salivary IL-18 levels (pg/ml)

  change in salivary IL-18 levels from baseline to 1 month and 3 months after treatment

  from baseline to 1 month and 3 months after treatment

Secondary Outcomes (5)

• Serum NLRP3 levels (ng/ml)

  from baseline to 1 month and 3 months after treatment

• Serum ASC levels (pg/ml)

  from baseline to 1 month and 3 months after treatment

• Serum Caspase-1 levels (ng/ml)

  from baseline to 1 month and 3 months after treatment

• Serum IL-1beta levels (pg/ml)

  from baseline to 1 month and 3 months after treatment

• Serum IL-18 levels (pg/ml)

  from baseline to 1 month and 3 months after treatment

Study Arms (3)

Healthy

NO INTERVENTION

Periodontally healthy patients received no intervention.

Gingivitis

ACTIVE COMPARATOR

Gingivitis group received Non-Surgical Periodontal Treatment. They received Scaling and Root Planning procedure with ultrasonic scalers and hand curettes. The entire non-surgical periodontal treatment of gingivitis groups was completed in a total of 2 sessions in a week.

Procedure: Non-Surgical Periodontal Treatment

Stage III Grade C Periodontitis

ACTIVE COMPARATOR

Stage III Grade C group received Non-Surgical Periodontal Treatment. They received Scaling and Root Planning procedure with ultrasonic scalers and hand curettes. 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-Surgical Periodontal Treatment

Interventions

Non-Surgical Periodontal Treatment PROCEDURE

The primary goal of nonsurgical periodontal therapy is to control microbial periodontal infection by removing bacterial biofilm, calculus, and toxins from periodontally involved root surfaces. Performing a thorough periodontal debridement under local anesthesia will stop disease progression and result in improvement in the clinical signs and symptoms of active disease

Gingivitis; Stage III Grade C Periodontitis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• having any diagnosed medical disorders such as diabetes mellitus, cardiovascular diseases, rheumatoid arthritis...
• usage of antibiotics, non-steroidal anti-inflammatory drugs and immunosuppressive agents within the past 6 months.
• periodontal treatment within the preceding 6 months.
• pregnant/ lactating/ postmenopausal females.
• Current orthodontic treatment.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases; Gingivitis; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival 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: October 4, 2023
• First Posted: October 10, 2023
• Study Start: March 4, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)