NCT05962567

Brief Summary

Aim of the study:

  1. 1.To investigate changes in the levels of Interleukin 34 (IL-34) in the Gingival crevicular fluid(GCF) of patients with stage II periodontitis patients before and after nonsurgical periodontal therapy and compare it with healthy individuals
  2. 2.To correlate changes in Gingival crevicular fluid level of Interleukin 34 with changes in periodontal parameters after nonsurgical periodontal therapy

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

May 12, 2023

Last Update Submit

July 25, 2023

Conditions

Periodontal Disease Stage 2

Outcome Measures

Primary Outcomes (1)

  • 1- To measure the IL - 34 levels in ng/L in GCF before &after Non-Surgical Periodontal Therapy of stage II periodontitis patients and compare it to healthy individuals

    1- To measure the IL - 34 levels in ng/L in GCF before \&after Non-Surgical Periodontal Therapy of stage II periodontitis patients and compare it to healthy individuals

    3 months

Secondary Outcomes (4)

  • To evaluate Plaque index before & after Non-Surgical Periodontal Therapy of stage II periodontitis patients

    3 months

  • To evaluate Gingival index before & after Non-Surgical Periodontal Therapy of stage II periodontitis patients

    3 months

  • To evaluate Probing depth before & after Non-Surgical Periodontal Therapy of stage II periodontitis patients

    3 months

  • To evaluate Clinical attachment level before & after Non-Surgical Periodontal Therapy of stage II periodontitis patients

    3 months

Study Arms (2)

Healthy individuals

NO INTERVENTION

No intervention

Stage II periodontitis patients

ACTIVE COMPARATOR

Non-surgical periodontal therapy by ultrasonic and universal curettes

Other: Non surgical periodontal therapy

Interventions

Non surgical periodontal therapyOTHER

scaling and subgingival debridement

Stage II periodontitis patients

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with stage II Periodontitis.
  • 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 Cornell Medical Index-Health Questionnaire).
  • Patients taking antibiotics, anti-inflammatory, and immunosuppressive therapy during the preceding 3 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry-Ain Shams University

Cairo, Egypt

RECRUITING

Related Publications (1)

  • Dikilitas A, Karaaslan F, Evirgen S, Ertugrul AS. Gingival crevicular fluid CSF-1 and IL-34 levels in patients with stage III grade C periodontitis and uncontrolled type 2 diabetes mellitus. J Periodontal Implant Sci. 2022 Dec;52(6):455-465. doi: 10.5051/jpis.2106260313. Epub 2022 Apr 12.

    PMID: 36468466RESULT

Related Links

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Hala A. Abuel Ela, Professor

    Professor at Faculty of Dentistry, Ain Shams University

    STUDY DIRECTOR

Central Study Contacts

Nada S. Ahmed

CONTACT

00201060041571nadazidan1271994@gmail.com

Yasmine A. Fouad, lecturer

CONTACT

00201005793929

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Supra and subgingival scaling will be performed on all patients. Oral Hygiene measures will be instructed following treatment and follow up after 3 months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc student

Study Record Dates

First Submitted

May 12, 2023

First Posted

July 27, 2023

Study Start

January 1, 2023

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

EG(1)