NCT05995067

Brief Summary

Periodontitis is a polymicrobial, inflammatory condition affecting tooth-supporting tissues. It is characterized by a progressive loss of epithelial attachment and resorption of alveolar bone, which can lead to tooth loss. Epithelial-mesenchymal transition (EMT) has been proposed as a reversible process that shifts the cell phenotype from epithelial to mesenchymal-like and may be involved in the process of periodontal inflammation either completely or partially. Long non-coding RNAs (lncRNAs) are a large class of regulatory transcripts longer than 200 nucleotides lacking evident protein-coding potential. Studies have shown that lncRNA dysregulation plays key roles in human diseases, including cancer, by modulating the epithelial-mesenchymal transition (EMT). The involvement of lncRNAs markers in the pathogenesis of periodontal disease induced EMT has not been studied thoroughly and have created a gap in the knowledge.

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
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

August 8, 2023

Last Update Submit

December 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • determining the relative expression of lncRNAs (NEAT1 and MALAT1) in healthy and diseased periodontal tissue.

    reverse transcription real time polymerase chain reaction

    one year

Secondary Outcomes (1)

  • determine the expression of EMT-related genes (E-cadherin, Vimentin, β-catenin, and Snail1), in healthy and diseased tissues, and their correlation with lncRNAs and clinical parameters.

    one year

Study Arms (2)

control group

-healthy groups/without the condition

study group

-diseased group-/with the condition (periodontitis)

Other: periodontitis challenge

Interventions

control will be compared to diseased group suffering from periodontal disease.

study group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with periodontitis, and healthy periodontal tissues will be recruited at the College of Dentistry/University of Baghdad and Al Sadir specialized dental center/Al-Risafa directorate/ Ministry of Health. No age or gender restriction.

You may qualify if:

  • Patients with no history of systemic disease e.g., diabetes.
  • Both males and females will be included in the study.
  • Control group: patients fit the case definition of gingival health2, and confirmed by Histopathological inflammatory cell infiltration analysis.
  • Periodontitis group: patients fit the case definition of periodontal disease referred for periodontal flap surgery (modified Widman's flap).
  • Patients radiographically confirmed with infrabony pocket eligible for periodontal flap surgery.

You may not qualify if:

  • Patients not willing to participate or consent.
  • Patient taking medications that affect or modify immunity (e.g., corticosteroid), for the last 3 months.
  • Patient taking NSAIDs for the last 3 months.
  • Active smoker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

saif mohammed T AL Mufti

Baghdad, 964, Iraq

Location

Biospecimen

Retention: SAMPLES WITH DNA

gingival tissue byproduct of resective periodontal surgery

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor- department of periodontics-college of dentistry- Baghdad university

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 16, 2023

Study Start

February 14, 2022

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

December 12, 2023

Record last verified: 2023-12

Locations