Interleukin-34 in Stage I and II Periodontitis

NCT06052774 | Completed

• 1 other identifier: FDASU-Rec IR 092303
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Interleukin 34 (IL-34) is the second active component of (colony-stimulating factor receptor) CSF-1R. With regards to periodontal disease, It is debatable whether IL-34 is a pro-inflammatory cytokine (as seen in rheumatic arthritis and Sjogren syndrome) or an anti-inflammatory cytokine( as seen in Alzheimer's disease) so further studies could be conducted to better understand whether IL-34 is a proinflammatory or anti-inflammatory cytokine in the pathogenesis of periodontal diseases and to evaluate the change of its levels in Gingival crevicular fluid (GCF) in patients with periodontal disease after non-surgical periodontal therapy (NSPT).

Conditions

Cytokine Storm

Outcome Measures

Primary Outcomes (1)

• To measure the IL - 34 levels in GCF before &after NSPT of stage I and II grade B periodontitis patients in comparison to periodontally healthy individuals

  To measure the IL - 34 levels in ng/L before \&after NSPT of stage I and II grade B periodontitis patients in comparison to periodontally healthy individuals

  3 months

Secondary Outcomes (4)

• To evaluate Plaque index before & after NSPT in Stage I and II grade B periodontitis patients

  3 months

• To evaluate Gingival index before & after NSPT in Stage I and II grade B periodontitis patients

  3 months

• To evaluate probing depth before & after NSPT in Stage I and II grade B periodontitis

  3 months

• To evaluate Clinical attachment Level before & after NSPT in Stage I and II grade B periodontitis

  3 months

Study Arms (3)

Stage I grade B periodontitis patients

ACTIVE COMPARATOR

Nonsurgical periodontal debridement was performed on patients using an ultrasonic scaler and universal curettes (2R - 2L and 4R- 4L). Oral Hygiene measures were instructed following treatment and maintenance visits were given to them.

Procedure: Non-Surgical periodontal therapy

Stage II grade B periodontitis patients

ACTIVE COMPARATOR

Nonsurgical periodontal debridement was performed on patients using an ultrasonic scaler and universal curettes (2R - 2L and 4R- 4L). Oral Hygiene measures were instructed following treatment and maintenance visits were given to them.

Procedure: Non-Surgical periodontal therapy

Periodontally healthy individuals

NO INTERVENTION

No intervention

Interventions

Non-Surgical periodontal therapy PROCEDURE

Supra and Subgingival debridement for all patients except periodontally healthy individuals

Stage I grade B periodontitis patients; Stage II grade B periodontitis patients

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with stage I and II grade B Periodontitis in addition to periodontally healthy individuals.
• Both genders aged from 20-50 years
• Minimum 20 natural teeth excluding third molars.
• Good compliance with the plaque control instructions following initial therapy.
• Availability for follow-up and maintenance program.

You may not qualify if:

• Smokers.
• Pregnant and lactating females.
• Systemic diseases that could affect the outcome of the therapy (According to the Cornell Medical Index-Health Questionnaire).
• Patients taking antibiotics, anti-inflammatory drugs, and immunosuppressive therapy during the preceding 6 months before the start of the trial and during the study.
• Patients who have undergone any periodontal therapy in the last 6 months.
• Vulnerable groups of patients' e.g. (handicapped patients).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry-Ain Shams University

Cairo, Egypt

Location

Related Links

• Serum cytokine levels in periodontitis patients in relation to the bacterial load
• Gingival Crevicular Fluid (GCF): A Diagnostic Tool for the Detection of Periodontal Health and Diseases
• Emerging roles of Interleukin-34 together with receptor activator of nuclear factor-kB ligand and
• Tooth loss in complying and non-complying periodontitis patients with different periodontal risk levels during supportive periodontal care
• Diagnostic potential and future directions of biomarkers in gingival crevicular fluid and saliva of periodontal diseases: Review of the current evidence
• Effect of nonsurgical periodontal therapy on interleukin-34 levels in periodontal health and disease
• Periodontitis: A Multifaceted Disease of Tooth-Supporting Tissues
• Discovery of a cytokine and its receptor by functional screening of the extracellular proteome
• Levels of myeloid-related proteins in saliva for screening and monitoring of periodontal disease
• Salivary Colony Stimulating Factor-1 and Interleukin-34 in Periodontal Disease
• Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions
• Staging and grading of periodontitis: Framework and proposal of a new classification and case definition
• Cytokines, inflammation, and pain

MeSH Terms

Conditions

Cytokine Release Syndrome

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• hala A. Abuel Ela, Professor

  Professor of Oral Medicine, Periodontology, Oral Diagnosis, Faculty of Dentistry, ASU

  STUDY DIRECTOR

• Doaa Adel-Khattab, Asso.Prof.

  Associate Prof. of oral medicine, Periodontology and Oral diagnosis Faculty of dentistry ASU

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: teaching assistant in periodontology department- Ain shams University

Model Details: Nonsurgical periodontal debridement was performed on patients using an ultrasonic scaler and universal curettes (2R - 2L and 4R- 4L). Oral Hygiene measures were instructed following treatment and follow-up after 3 months.

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 25, 2023
• Study Start: January 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

EG (1)