NCT05834946

Biological Responses Affecting Early-stage Dental Implant Placement in Patients With History of Periodontitis

Identification of Biological Responses as a Causal Link for the Increased Peri-implantitis in Patients With History of Periodontitis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University of Malaya · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This prospective parallel, double-blind, four-arm randomised controlled clinical study is planned to assess the difference in the level of the inflammatory biomarkers expressed following the placement of the first dental implant in patients with history of periodontitis (successfully treated) and healthy controls without the disease, during implant osseointegration period. The subjects in both groups will also be randomised to receive one of the two types of implants provided which have different surface treatment.

Detailed description

This is a prospective, parallel, double-blind, four-arm randomised clinical control study, aims to investigate the changes of clinical parameters and pro-inflammatory biomarkers expression and the shift following the first dental implant placement in patients who have been successfully treated for periodontitis, compared with healthy control without the disease. The main questions to answer are: 1. Why do patients with history of periodontitis are at a greater risk to develop peri-implantitis than patients without history of periodontitis? 2. Is there any difference in the microbial composition, histological and immunological reaction of the host's dental plaque, peri-implant soft tissue, gingival crevicular fluids (GCF) of adjacent teeth and peri-implant sulcular fluids (PISF) following implant placement in patients with and without a history of periodontitis? The test group will consist of subjects with stabilised periodontitis, whilst the control group will consist of healthy patients with no history of periodontitis, as identified via history taking and clinical screening. Periodontal condition will be determined based on the new 2017 periodontal classification. All participants in both groups will be randomised to receive one of two types of implants with different surface treatment. Clinical measurement, GCF and PISF will be collected around the single implant and adjacent teeth, at the following stages (time-point): * Baseline (pre-operative) * After implant placement (prior to the second stage surgery) * After implant exposure (prior to the crown restoration) * 3-month after the implant is restored * Soft tissue will be obtained during the first stage (baseline) and second stage implant surgery (post-operative) and analysed.

Conditions

• Periodontitis
• Peri-implant Mucositis
• Peri-Implantitis

Interventions

Type	Name	Description
OTHER	Megagen implant placement	Megagen implant with sand-blasted, large-grit, acid-etched (SLA) and nano-calcium ions incorporated surface
OTHER	Biomate-Swiss implant	Biomate-Swiss implant with precision dimension laser (PDL) surface

Timeline

• Start date: 2021-03-04
• Primary completion: 2023-05-30
• Completion: 2025-05-30
• First posted: 2023-04-28
• Last updated: 2023-10-18

Locations

1 site across 1 country: Malaysia