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| Name | Class |
|---|---|
| McGill University Health Centre/Research Institute of the McGill University Health Centre | OTHER |
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The use of titanium dental implants has become a common modern treatment to restore teeth. Although the success rate of dental implants is high, inflammation around the dental implant still occurs. The current study will investigate if the inflammation around the implant is due to bacterial infection, hypersensitivity or both.
The goal of this cross-sectional study is to (1) Establish the levels of cytokines in peri-implant crevicular fluid associated with bacterial infection and hypersensitivity reaction; (2) Compare the levels of cytokines associated with hypersensitivity and bacterial infection between healthy implants and inflamed implants (peri-mucositis and peri-implantitis); (3) Determine whether the difference in the levels of cytokines, if they exist, reflects the clinical diagnosis of healthy implants and inflamed implants.
The main objective of this study is to:
Secondary objectives includes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional Dental Implant | An implant restored with a prothesis and in function for a minimum of one year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical examination of a dental implant | Diagnostic Test | Clinical examination includes bleeding on probing, pocket depth, gingival biotype, suppuration, gingival index |
|
| Measure | Description | Time Frame |
|---|---|---|
| Health status of the implant | Classifying the implant into healthy implant, peri-implant mucositis and peri-implantitis according to the 2017 World Workshop (Berglundh et al. 2018). | Baseline (Cross-sectional) |
| Levels of inflammatory mediators in Periimplant crevicular fluid | Establishing the the levels of cytokines in peri-implant crevicular fluid associated with bacterial infection (Type 1 and 3: IL-1, IL-6, IL-12, IL-17, IL-23, GM-CSF, IFN-γ, TNF-α), hypersensitivity reaction (Type 2: IL-4, IL-5, and IL-13) and the level of MMPs and including MMP-1, MMP-2, MMP-3, MMP-9 and MMP-13. | Baseline (Cross-sectional) |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival Crevicular fluid volume | Measuring the volume of peri-implant crevicular fluid using Periotron device. The measurement unit is μL. | Baseline (Cross-sectional) |
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Inclusion Criteria:
Exclusion criteria:
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This cross-sectional study is carried out at McGill University Health Center (MUHC) - Montreal General Hospital Oral and Maxillofacial Clinic. The electronic dental records database at the MUHC Montreal General Hospital Oral and Maxillofacial clinic were screened to identify potentially eligible participants. Individuals who had a functional implant (implant restored with a prosthesis) placed between year 2010 and year 2016 were reviewed. Eligible individuals are contacted and invited to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Heba Allah Madi Dr | McGill University | Principal Investigator |
| Jocelyne Feine Dr | McGill University | Study Chair |
| Nicholas Makhoul Dr | McGill University & McGill University Health Centre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal General Hospital - Oral & Maxillofacial Surgery Clinic | Montreal | Quebec | H3G 1A4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29926491 | Background | Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957. | |
| 33376734 |
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There is no plan to make individual participant data (IPD) available to other researchers.
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Peri-implant crevicular fluid
| Radiological Examination | Diagnostic Test | A standardized periapical radiograph in parallax technique will be taken. |
|
| Peri-implant crevicular fluid sample collection | Diagnostic Test | A sample of the peri-implant crevicular fluid will be collected using paper strip for 60 seconds. The sample of the fluid will be a resultant of inserting six different strips at the same time in six sites of the implant including mesiobuccal, midbuccal, distobuccal, distopalatal/distolingual, midpalatal/midlingual, mesiopalatal/mesiolingual sites of the implant. |
|
| Background |
| Baseri M, Radmand F, Hamedi R, Yousefi M, Kafil HS. Immunological Aspects of Dental Implant Rejection. Biomed Res Int. 2020 Dec 9;2020:7279509. doi: 10.1155/2020/7279509. eCollection 2020. |
| 25528359 | Background | Annunziato F, Romagnani C, Romagnani S. The 3 major types of innate and adaptive cell-mediated effector immunity. J Allergy Clin Immunol. 2015 Mar;135(3):626-35. doi: 10.1016/j.jaci.2014.11.001. Epub 2014 Dec 18. |
| 34576463 | Background | Poli PP, de Miranda FV, Polo TOB, Santiago Junior JF, Lima Neto TJ, Rios BR, Assuncao WG, Ervolino E, Maiorana C, Faverani LP. Titanium Allergy Caused by Dental Implants: A Systematic Literature Review and Case Report. Materials (Basel). 2021 Sep 12;14(18):5239. doi: 10.3390/ma14185239. |
| 28478213 | Background | Lee CT, Huang YW, Zhu L, Weltman R. Prevalences of peri-implantitis and peri-implant mucositis: systematic review and meta-analysis. J Dent. 2017 Jul;62:1-12. doi: 10.1016/j.jdent.2017.04.011. Epub 2017 May 3. |
| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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