Biological Responses Affecting Early-stage Dental Implant Placement in

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05834946
Study type	Interventional
Source	University of Malaya
Contact
Status	Active, not recruiting
Phase	N/A
Start date	March 4, 2021
Completion date	May 30, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms