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

NCT04299386 | Unknown DMC

• 1 other identifier: CERC-19-084-P
• Study Type: interventional
• Target: 390
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Dental implants; Infection control; Bone Healing; professional cleaning

Outcome Measures

Primary Outcomes (2)

• Change in Bleeding on probing index

  semi-quantitative assessment of bleeding after probing around each implant 0 = No bleeding 1. Isolated minimal bleeding spots 2. Blood forming a confluent red line on the margin 3. Heavy or profuse bleeding

  4 weeks, 6 months, 1 year

• Change in Probing depth (PD)

  probing depth in mm of peri-implant tissues around each implant

  4 weeks, 6 months, 1 year

Secondary Outcomes (4)

• Modified Gingival Index

  4 weeks, 6 months, 1 year

• modified plaque index

  4 weeks, 6 months, 1 year

• gingival suppuration after probing

  4 weeks, 6 months, 1 year

• Crestal bone level (CBL)

  6 months, 1 year

Study Arms (4)

NeoPhylaxis

EXPERIMENTAL

Nanocrystalline gel for nonsurgical cleaning of implants

Device: NeoPhylaxis

ImplanTreat

EXPERIMENTAL

Nanocrystalline gel for surgical cleaning of Implants

Device: ImplanTreat

Nonsurgical cleaning without gel

NO INTERVENTION

Cleaning dental implants non-surgically using the electric brush without the gel

Surgical cleaning without gel

NO INTERVENTION

Cleaning dental implants surgically using the electric brush without the gel

Interventions

NeoPhylaxis DEVICE

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.

NeoPhylaxis

ImplanTreat DEVICE

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.

ImplanTreat

Eligibility Criteria

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

You may qualify if:

• Male or female patients aged 18 years and older.
• Patients with upper or lower implant-supported/retained prostheses.
• The implant should be in function for 12 months or more.
• To be included in group I, peri-implant mucositis should be diagnosed.
• To be included in group II, peri-implantitis should be diagnosed.

You may not qualify if:

• Patients who have undergone radiotherapy in the head and neck region, chemotherapy or systemic long-term corticosteroid treatment;
• Patients receiving medications known to induce gingival hyperplasia;
• Patients who have taken systemic antibiotics less than 3 months prior to baseline;
• Patients with prosthetic factors that prevent clinical measurements
• Implants with technical complications, such as poor marginal contour or any type of prosthetic complication that would be a local contributing factor to chronic inflammation.
• Peri-implant bone loss 50% \[47\]
• Presence of any acute oral infection.
• Presence of uncontrolled diabetes or other systemic diseases.
• Intravenous bisphosphonates
• Oral bisphosphonate intake for more than 3 years.

Sponsors & Collaborators

• Université de Montréal: lead

Study Officials

• Robert Durand

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Durand, DMD, MS

CONTACT

514-343-7464; robert.durand@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Double-masked parallel-arm randomized clinical trial

Study Record Dates

• First Submitted: March 1, 2020
• First Posted: March 6, 2020
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 5, 2023

Record last verified: 2023-07