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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04299386
Other study ID # CERC-19-084-P
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date July 1, 2024

Study information

Verified date July 2023
Source Université de Montréal
Contact Robert Durand, DMD, MS
Phone 514-343-7464
Email robert.durand@umontreal.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Université de Montréal

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Bleeding on probing index semi-quantitative assessment of bleeding after probing around each implant 0 = No bleeding
Isolated minimal bleeding spots
Blood forming a confluent red line on the margin
Heavy or profuse bleeding
4 weeks, 6 months, 1 year
Primary Change in Probing depth (PD) probing depth in mm of peri-implant tissues around each implant 4 weeks, 6 months, 1 year
Secondary Modified Gingival Index semi-quantitative assessment of gingival health around each implant 0 Absence of inflammation;
Mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary
Mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary
Moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary
Severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration
4 weeks, 6 months, 1 year
Secondary modified plaque index semi-quantitative assessment of plaque around each implant(1 = Plaque only detected by running a probe along the smooth surface of the healing abutment, 2 = Plaque can be seen by the naked eye, 3 = Abundance of soft matter) 4 weeks, 6 months, 1 year
Secondary gingival suppuration after probing presence or absence of pus exudate after probing around each implant 4 weeks, 6 months, 1 year
Secondary Crestal bone level (CBL) variations in mm of the alveolar bone around each implant 6 months, 1 year
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