Genomic and Proteomic Analyses of Apoptosis Mechanisms in Diseased Peri-implant Tissue

NCT06865976 | Completed

• 2 other identifiers: E-16214662-050.01.04-85,162-21BIDEB-1059B192100836
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 72 individuals were included in the study: 23 with peri-implant mucositis, 25 with peri-implantitis, and 24 healthy controls. Clinical and radiological parameters, including keratinized mucosa width, modified bleeding index, probing depth, modified plaque index, modified gingival index, and marginal bone loss percentage, were recorded. Granulation tissues were collected during peri-implant disease treatments, while healthy control tissues were obtained during the second stage of implant surgery. Tissue levels of Bcl-2 family pro-apoptotic and anti-apoptotic proteins were measured using multiplex immunoassay, and tissue levels of P. gingivalis gingipain and T. denticola dentilisin with immunoblotting.

Conditions

Apoptosis; Apoptosis Regulatory Proteins; Proteases; Peri-Implantitis and Peri-implant Mucositis

Outcome Measures

Primary Outcomes (1)

• Bcl-2 family protein levels in peri-implant tissues

  The thawed tissue samples were first weighed and subsequently sectioned into small pieces with disposable scalpels (#11 and #15). The processed tissue fragments were transferred to 2 mL tubes containing four ultrapure zirconium microspheres (3 mm diameter) and 400 μL of lysis buffer. Homogenization was performed using a high-speed tissue homogenizer set at 2000 rpm for four cycles of 60 seconds each, with 20 second intervals on ice to prevent overheating. After homogenization, the samples were centrifuged at 10000 rpm for 4 minutes, and the zirconium beads were removed. Ultrasonication was performed at 0.5 cycle and 100% amplitude in three 5-second cycles, with 20-second intervals on ice between the cycles. The samples were then centrifuged again at 10000 rpm for 4 minutes, and the supernatants were carefully transferred to new tubes.The levels of Bcl-2 family proteins were quantified using a bead-based immunoassay system.

  From the time of clinical intervention to study completion, an average of 6 months.

Secondary Outcomes (1)

• Immunoblot analyses of P. gingivalis gingipain and T. denticola dentilisin

  From the time of clinical intervention to study completion, an average of 9 months.

Study Arms (3)

Control

peri-implant tissue health

Procedure: Second stage surgery

peri-implant mucositis

Peri-implant mucositis was diagnosed in cases of bleeding and/or suppuration upon probing, with no evidence of bone loss beyond the crestal level changes associated with initial bone remodeling, as determined by comparing follow-up and baseline radiographs.

Procedure: Non-Surgical Intervention

peri-implantitis

Peri-implantitis was diagnosed based on the presence of bleeding and/or suppuration upon probing, probing depths ≥6 mm, and radiographic bone levels ≥3 mm apical to the most coronal portion of the intraosseous part of the dental implant (Berglundh et al., 2018).

Procedure: Surgical peri-implant therapy

Interventions

Non-Surgical Intervention PROCEDURE

For non-surgical treatment of peri-implant mucositis, granulation tissues were removed by titanium curettes (Hu-Friedy, Titanium Implant Scaler Mini-Five, Chicago, IL, USA) during mechanical debridement under local anesthesia

peri-implant mucositis

Surgical peri-implant therapy PROCEDURE

In cases requiring surgical intervention for peri-implantitis, mucoperiosteal flaps were elevated on both vestibular and oral aspects after administration of local anesthesia (articaine with epinephrine 1:200,000) to expose the peri-implant defect. Granulation tissue from the bony defect area was meticulously excised using by titanium curettes (Hu-Friedy, Titanium Implant Scaler Mini-Five, Chicago, IL, USA).

peri-implantitis

Second stage surgery PROCEDURE

Healthy peri-implant mucosa samples were obtained during the second-stage surgery of implant placement procedures. These samples consisted of incisional biopsies of peri-implant mucosa in direct contact with the implant surface.

Control

Eligibility Criteria

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

Study Population

Recruitment took place between March 2021 and June 2022, involving patients who attended the clinics of the Department of Periodontology, Sakarya University. These patients were either in the maintenance phase following dental implant therapy, actively undergoing implant treatment, or presenting with complications related to dental implants placed at other centers. A total of 72 participants, encompassing 72 dental implants, were enrolled in the study. These participants were categorized as follows: 23 systemically healthy individuals with peri-implant mucositis, 25 individuals with peri-implantitis, and 24 healthy controls.

You may qualify if:

• Partially or fully edentulous patients rehabilitated with single or multiple implant-supported prostheses
• Dental implants with functional restorations in place for a minimum of one year, -at least one screw-type titanium implant (single or two-piece) diagnosed with peri-implant mucositis or peri-implantitis and requiring treatment (for diseased groups)
• Non-smokers or former smokers (individuals who had quit smoking for at least five years prior to the study)

You may not qualify if:

• Systemic contraindications to dental or surgical treatments
• Active periodontal disease
• Pregnancy or lactation
• Autoimmune or inflammatory diseases
• Uncontrolled diabetes (HbA1c \> 7)
• Ongoing corticosteroid therapy
• Current smoking

Sponsors & Collaborators

• Sakarya University: lead
• University of Turku: collaborator
• University of Helsinki: collaborator

Study Sites (1)

Sakarya University

Sakarya, 54100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

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

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 10, 2025
• Study Start: March 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2024
• Last Updated: March 10, 2025

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

TU (1)