Epithelial Mesenchymal Transition and Periodontitis

NCT05403164 | Unknown

• 1 other identifier: 241621
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontitis is a chronic inflammatory disease results is destruction of the attachment apparatus of the teeth and ultimately tooth loss. Epithelial-mesenchymal transition (EMT) is a process comprises of series of events that influence a polarized epithelial cell to undergo molecular/morphological changes leading to acquisition of mesenchymal cell phenotype. This process is responsible for suppressing epithelial-phenotype and it is known to be triggered by chronic exposure to inflammatory cytokines, Gram-negative bacteria, hypoxia, smoking, and hyperglycemia. Both periodontitis and EMT share common risk factors/promoters; however, the role of EMT in the pathogenesis of periodontitis is not fully elucidated yet. Potential induction of EMT within periodontal pockets may disrupt epithelial barrier thus facilitating invasion of pathogenic periodontal pathogens to deeper tissues resulting in further tissue breakdown and non-resolving periodontal lesion.

Conditions

Periodontitis; Periodontal Diseases; Epithelial-Mesenchymal Transition; Transcription Factors; Epithelial Attachment; Gram-Negative Bacteria

Outcome Measures

Primary Outcomes (2)

• Clinical attachment loss (CAL)

  CAL is a linear distance (in mm) from cemento-enamel junction to the base of the sulcus/periodontal pocket measured by using a periodontal probe, recorded at six sites per tooth namely; mesio-facial, mid-facial, disto-facial, mesio-oral, mid-oral, disto-oral.

  Measured at baseline only before conducting periodontal surgery

• Probing pocket depth (PPD)

  PPD is the distance (in mm) from the gingival margin to the base of the sulcus/periodontal pocket measured by using a periodontal probe, recorded at six sites per tooth namely; mesio-facial, mid-facial, disto-facial, mesio-oral, mid-oral, disto-oral.

  Measured at baseline only before conducting periodontal surgery

Secondary Outcomes (2)

• Bleeding on probing (BOP)

  Measured at baseline only before conducting periodontal surgery

• Immunohistochemical expression of EMT-related markers

  Measured at baseline

Study Arms (2)

Periodontitis

Patients with periodontitis which is defined by interdental clinical attachment loss (CAL) ≥ 2 non-adjacent teeth, or Buccal or Oral CAL ≥ 3 mm with probing pocket depth (PPD) \> 3 mm is detectable at ≥2 teeth. All patients should be indicated for periodontal surgery.

Procedure: Modified Widman flap

Healthy periodontium

Healthy periodontium is defined by absence of CAL, PPD ≤3 mm, bleeding on probing \<10%, and no evidence of radiological bone loss. Gingival samples are collected from subjects referred for gingivectomy for esthetic reasons such as crown lengthening, gummy smile or prior to teeth extraction for orthodontic treatment.

Procedure: Gingivectomy

Interventions

Modified Widman flap PROCEDURE

1. Administration of anaesthesia 2. First incision (reversed bevel incision), scalpel is placed at 45 degree, 2mm apical to gingival margin in coronal-apical direction until touching the bone and moved continuously around the teeth without any vertical releasing incisions 3. Partial mobilization of the mucoperiosteal flap (full thickness flaps both facially and orally) within the attached gingiva to the alveolar crest 4. Second incision (sulcular incision) 5. Third incision (horizontal incision), also interdentally to remove the delineated tissue and all granulation tissue which is used later for analysis. 6. Root surface debridement 7. Flap adaptation, complete coverage interdentally and suturing.

Periodontitis

Gingivectomy PROCEDURE

1. Administration of anaesthesia 2. Marking the base of the sulcus with pocket marker tweezer. 3. First incision (gingivectomy incision), scalpel blade placed 1mm apical to the bleeding points and the incision should be beveled 45 degrees coronally. 4. Second incision (interdental) to free the tissue which is used for analysis later. 5. Debriding the area and applying periodontal pack.

Healthy periodontium

Eligibility Criteria

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

Study Population

Participants involved in this study are recruited from the patient attending to the Department of Periodontics, College of Dentistry, University of Baghdad. Those patients were treated non-surgically by the residents in the department. Primary endpoint of is assessed three months after completion of non-surgical therapy. Patients with persistent pockets at posterior teeth indicated for modified Widman flap are included in the study. Prior to enrollment, aims and details of the study are clearly explained to the patients who then asked to sign the consent form. All procedures in this study followed Helsinki declaration and its later amendments for conducting human researches.

You may qualify if:

• Diagnosed with generalized periodontitis, unstable, no risk factor
• Selected site should be indicated for surgical treatment by modified Widman flap in posterior area and these sites must exhibit periodontal pockets ≥ 5mm or pockets ≥ 4mm with BOP
• Plaque index score \< 10%
• Never smoker or former smoker
• Not currently using systemic or local antimicrobials (at least in the last three months)
• Not currently using a mouth rinse
• In good general health with no evidence of any systemic disease
• Willing to consent

You may not qualify if:

• Have history of systemic disease e.g., diabetes mellitus
• Periodontal treatment in the last 6 months
• Current participation in other clinical trials
• Pregnant women
• Current smoker
• Not willing to sign the consent form

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

College of Dentistry, University of Baghdad

Baghdad, Iraq

RECRUITING

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases

Interventions

Gingivectomy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry; Periodontics

Central Study Contacts

Saif S Saliem, MSc

CONTACT

+964 7901529484; drsaifjuma@codental.uobaghdad.edu.iq

Ali A Abdulkareem, PhD

CONTACT

+964 7806866717; ali.abbas@codental.uobaghdad.edu.iq

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 3, 2022
• Study Start: July 12, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: June 3, 2022

Record last verified: 2022-05

Locations

IR (1)