Effect of Nanocrystal Gels on the Management of Peri-implant Diseases

Summary

Dental implants are a well-accepted treatment for replacing missing teeth, due to excellent patient satisfaction regarding function, aesthetics, and comfort, as well as their long-term survival. However, the accumulation of bacterial biofilm on implants changes their surface biocompatibility and initiates peri-implant diseases, such as peri-implant mucositis and peri-implantitis. Professional cleaning of the implant surface is necessary to remove the biofilm and facilitate healing within the surrounding tissue. Prophylaxis pastes can be used in dental clinics to assist the mechanical removal of biofilm by dental professionals. However, these pastes can contain abrasives that detrimentally affect the surface stability and chemical properties of the implant surfaces.

ImplanTreat® and Neophylaxis® are novel nanocrystal gels designed for implants' professional cleaning, under surgical and non-surgical procedures respectively. These products present high biocompatibility proprieties that can improve peri-implant bone healing. Moreover, they don't contain abrasives, or fluoride, which preserves the implant surfaces. The researchers hypothesize that professional implant cleaning with Neophylaxis® or ImplanTreat® results in a greater reduction of peri-implant inflammation and dental plaque accumulation in comparison to cleaning without any product. Accordingly, the purpose of this study is to verify if Neophylaxis® and ImplanTreat® enhance the efficacy of professional cleaning and preserve implant surface roughness.

The researchers will randomly divide the recruited participant into two groups depending on the clinical diagnosis, each patient will be either recruited in peri-implant mucositis group (Group I), or in peri-implantitis group (Group II). Each patient in the group I will be assigned randomly to receive either implant cleaning with Neophylaxis® or cleaning without. Similarly, each patient in group II will be assigned randomly to receive either implant cleaning with ImplanTreat® or cleaning without. No participant will be aware of his allocation before the end of data collection. In each evaluation session, The researchers will examine the participants' implants and evaluate the removal of biofilm as well as the improvement of the peri-implant tissue health and bone level. The researchers will then analyze and compare the results obtained from each study group.

Conditions

• Dental Implant Failure Nos

Interventions

DEVICE

NeoPhylaxis

NeoPhylaxis® gel is designed for the non-surgical decontamination of the implant surface and can be used for professional regular implant maintenance, with or without peri-implant mucositis. It contains the same ingredients, Magnesium Phosphate (3.02% w/v) and Sodium Phosphate (8.23% w/v) in 3 mL syringe in non-sterile form.

DEVICE

ImplanTreat

ImplanTreat® gel can be used for the surgical decontamination of the implant surface and can be used to decontaminate implants with peri-implantitis. It contains the same ingredients, Magnesium Phosphate (3.02% w/v) and Sodium Phosphate (8.23% w/v) in 3 mL syringe in sterile form.

Sponsors & Collaborators

• Université de Montréal

  lead OTHER

Principal Investigators

• Robert Durand · Université de Montréal

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-07-01

Primary Completion

2024-07-01

Completion

2024-07-01