Characterizing the Inflammation Around Dental Implants

Peri-Implantitis Clinical Trial

Official title:

Characterizing the Inflammation Around Dental Implants: Bacterial Infection, Hypersensitivity, or Both?

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05675241
• Other study ID #: 2022-7639
• Status: Enrolling by invitation
• Start date: September 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2022
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

The main objective of this study is to:

1. Establish 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.

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.

Secondary objectives includes:

1. Measure the volume of peri-implant crevicular fluid and compare it between healthy implants and inflamed implants (peri-mucositis and peri-implantitis).

2. Investigate the association between the levels of cytokines and the severity of inflammatory responses.

3. Show how levels of cytokines influence the severity of inflammatory responses.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 177
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Received at least one functional implant (implant restored with a prothesis);

• Did not receive peri-implant mucositis and peri-implantitis treatment in the past three months.

Exclusion criteria:

• Dental records with incomplete information;

• Individuals with a weak immune system or chronic disease such as diabetes, heart, lung or kidney disease;

• Pregnant women;

• Individuals undergoing orthodontic therapy and those who have oral piercing.

• History of diseases that modify or suppress the immune and inflammatory response, including rheumatoid arthritis, diabetes, lupus, and inflammatory bowel disease and metastatic cancer;

• Taking medications that cause antiresorptive osteonecrosis of the jaw (including any dose of intravenous bisphosphonates, oral bisphosphonate intake for more than three years, receptor activator of nuclear factor kappa-B ligand inhibitors, or antiangiogenic medications);

• Taking medications known to induce gingival hyperplasia including anticonvulsants, immunosuppressants, or calcium channel blockers;

• Taking steroid medications, systemic or local antibiotics in the last three months (as this may affect the interleukins activity);

• Received radiation therapy to the head and neck or chemotherapy;

• Received treatment to manage an inflamed implant, including management of peri-implantitis and peri-implant mucositis in the last three months.

Related Conditions & MeSH terms

• Communicable Diseases
• Hypersensitivity
• Implant Infection
• Implant Site Infection
• Implant Site Reaction
• Infections
• Inflammation
• Mucositis
• Peri-implant Mucositis
• Peri-Implantitis

Intervention

Diagnostic Test:
• Clinical examination of a dental implant
Clinical examination includes bleeding on probing, pocket depth, gingival biotype, suppuration, gingival index
• Radiological Examination
A standardized periapical radiograph in parallax technique will be taken.
• Peri-implant crevicular fluid sample collection
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.

Locations

Country	Name	City	State
Canada	Montreal General Hospital - Oral & Maxillofacial Surgery Clinic	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University	McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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-?, TNF-a), 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)
Secondary	Gingival Crevicular fluid volume	Measuring the volume of peri-implant crevicular fluid using Periotron device. The measurement unit is µL.	Baseline (Cross-sectional)