Characterizing the Inflammation Around Dental Implants

NCT ID: NCT05675241

Last Updated: 2023-01-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 177 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-12-01

Brief 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.

Detailed 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.

Conditions

Peri-Implantitis; Peri-implant Mucositis; Implant Site Reaction; Implant Site Infection; Hypersensitivity; Implant Site Rash; Implant Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Functional Dental Implant

An implant restored with a prothesis and in function for a minimum of one year.

Clinical examination of a dental implant

Intervention Type: DIAGNOSTIC_TEST

Clinical examination includes bleeding on probing, pocket depth, gingival biotype, suppuration, gingival index

Radiological Examination

Intervention Type: DIAGNOSTIC_TEST

A standardized periapical radiograph in parallax technique will be taken.

Peri-implant crevicular fluid sample collection

Intervention Type: 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.

Interventions

Clinical examination of a dental implant

Clinical examination includes bleeding on probing, pocket depth, gingival biotype, suppuration, gingival index

Intervention Type: DIAGNOSTIC_TEST

Radiological Examination

A standardized periapical radiograph in parallax technique will be taken.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: collaborator

McGill University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heba Allah Madi Dr

Role: PRINCIPAL_INVESTIGATOR

McGill University

Jocelyne Feine Dr

Role: STUDY_CHAIR

McGill University

Nicholas Makhoul Dr

Role: STUDY_DIRECTOR

McGill University & McGill University Health Centre

Locations

Montreal General Hospital - Oral & Maxillofacial Surgery Clinic

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 29926491 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33376734 (View on PubMed)

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 34576463 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28478213 (View on PubMed)

Other Identifiers

2022-7639

Identifier Type: -

Identifier Source: org_study_id