NCT05832541 Expression of Epithelial-Mesenchymal Transition Associated Markers in Peri-implant Tissues
| NCT ID | NCT05832541 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Baghdad |
| Condition | Peri-implantitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-08-18 |
| Primary Completion | 2024-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2022-08-18 with a primary completion date of 2024-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Peri-implantitis is an inflammation of bacterial etiology characterized by inflammation of mucous membranes and bone loss around the dental implant. A specific dental plaque bacteria could stimulate host cells, including the junctional epithelium, to secrete a range of pro-inflammatory cytokines involved in initiating the epithelial-mesenchymal transition (EMT) process. EMT has been described as the transdifferentiation of epithelial cells into motile mesenchymal cells. Moreover, cytokines and bacterial products have been highlighted as EMT-predisposing factors. The EMT process could render epithelial cells to lose their cell-cell adhesion and cell polarity that lend these cells to lose their function as an integrated epithelial barrier. E-cadherin is a calcium-dependent cell adhesion molecule that establishes cell-cell adhesion that plays a critical role in maintaining a barrier function in the human epithelium, including gingiva. The loss of E-cadherin is one of the most common biological indicators for EMT. In contrast, vimentin is an intermediate filament expressed in mesenchymal cells and is a canonical marker for EMT, which also promotes cell motility and an invasive phenotype. It is largely reported that EMT is regulated by various transcriptional factors such as Snail Family Transcriptional Repressor SNAIL1 and SNAIL2, zinc-finger E-box-binding (ZEB)1 and ZEB2 and TWIST transcription factors that suppress epithelial marker genes, and activate genes related with the mesenchymal phenotype. Recently, in vivo study has investigated the level of EMT markers in the gingival tissues of periodontitis patients. It was found that the expression of E-cadherin was downregulated while vimentin expression was upregulated. Despite the similarities and differences between the pathogenesis of periodontal and peri-implant diseases, the role of dental biofilm in the etiopathogenesis of the aforementioned diseases was studied largely. While it is now accepted that EMT may potentially play a role in periodontal disease pathogenicity, the possible role of EMT in the disintegration of the peri-implant epithelial barrier and the pathogenesis of peri-implant disease has not yet been investigated.
Eligibility Criteria
Inclusion Criteria: * For test group: adult patient age ≥18 years old presented having at least one dental implant with the following criteria for test group 1: (a) be in function for \>12 months; (b) clinically diagnosed as peri-implantitis with probing pocket depth ≥ 6 mm, bleeding on probing and/or suppuration; (c) presence of radiographic bone loss when compared to previous radiographs or with bone loss ≥ 3 mm apical to the 1st thread of the fixture; (d) presence of visual signs of inflammation. * For the control group: adult patient age ≥18 years old presented with: (a) one or more adjacent missing teeth in the posterior maxilla or mandible (positions premolar to molar); (b) adequate bone quality and availability for an implant placement of 4.5- 5.0 mm diameter and 8.5-13 mm length; (c) keratinized mucosa (KT) width of at least 3 mm. for both groups the patients give written consent to participate and attend the planned follow-up visits Exclusion Criteria: * For the test group: the exclusion criteria will be as follows: (a) patients with a history of chronic diseases such as diabetes mellitus; (b) currently smokers; (c) pregnant or lactating women; (d) patients who received peri-implant surgical therapy within 6 months before sampling; (e) patients who received antimicrobial therapy (systemic or local) within 3 months before sampling. * For the control group: the exclusion criteria will be as follows: (a) medical condition contraindicating implant surgery; (b) local inflammation (including untreated periodontitis); (c) post-extraction sites with less than 6 weeks of healing; (d) persistent intraoral infection; (e) absence of keratinized tissue; (f) history of chronic diseases such as diabetes mellitus; (g) currently a smoker and former smoker
Contact & Investigator
Talib A Alnajaty
PRINCIPAL INVESTIGATOR
University of Baghdad
Frequently Asked Questions
Who can join the NCT05832541 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peri-implantitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05832541 currently recruiting?
Yes, NCT05832541 is actively recruiting participants. Contact the research team at taleb.ali1105a@codental.uobaghdad.edu.iq for enrollment information.
Where is the NCT05832541 trial being conducted?
This trial is being conducted at Karbala, Iraq.
Who is sponsoring the NCT05832541 clinical trial?
NCT05832541 is sponsored by University of Baghdad. The principal investigator is Talib A Alnajaty at University of Baghdad. The trial plans to enroll 40 participants.