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| Name | Class |
|---|---|
| Invicare Inc. | UNKNOWN |
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This study aims to evaluate a gel's potential to improve gum health around dental implants when used alongside traditional cleaning methods. The central research question is:
Does the gel reduce gum bleeding?
Researchers will compare the effects of traditional dental cleaning alone wit those of dental cleaning combined with gel administration, focusing on overall gum health around implants. The study will enroll eight participants-some with early gum issues, such as bleeding gums, and others with healthy gums. Each participant will be randomly assigned to receive either regular dental cleaning or the cleaning paired with gel application.
The study process includes the following steps:
This clinical study, conducted at Laval University's graduate periodontics clinic, investigates the efficacy and safety of a nanocrystal gel as a supplementary treatment to non-surgical mechanical debridement (professional cleaning) for managing peri-implant mucositis-a reversible inflammatory condition affecting the soft tissues around dental implants. The study enrolls eight participants, comprising individuals with either healthy peri-implant tissues or peri-implant mucositis. Participants are randomly assigned to one of two groups: the test group receives the nanocrystal gel in conjunction with standard peri-implant therapy, while the control group undergoes peri-implant therapy alone.
The primary focus of the investigation is the bleeding on probing (BoP) parameter, analyzing its progression over a four-week period and comparing outcomes between the two groups. Additionally, other clinical parameters, including the modified gingival index, modified plaque index, and pocket depth, are evaluated.
Participants receive one of the designated treatments, with the study design ensuring they are blinded to the specific treatment administered. A follow-up appointment four weeks later allows for the reassessment of all recorded clinical parameters. One week after treatment, participants complete a survey to report any discomfort or pain experienced post-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental | This group received standard mechanical debridement around the implants with a nanocrystal gel administered topically as an adjunct treatment. |
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| Control group | Active Comparator | This group only received standard mechanical debridement around implants. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Innovative Gel application | Drug | Innovative gel application: Gel is applied as an adjunct treatment to cleaning and scaling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding on probing (BOP) | A periodontal probe is gently inserted into the sulcus (the space between the implant and the surrounding gum tissue). The probe is moved around the implant in a sweeping motion, covering all surfaces (Mesial, Distal, Buccal and Palatal/Lingual). This gesture is done with light pressure to avoid causing unnecessary trauma to the tissues. After probing, the clinician observes the site for any bleeding. Bleeding that occurs within 10 to 15 seconds after probing is recorded as a positive BOP result. | First assessment is the day of the intervention and the last one is 4 weeks later at follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque index (PI) | The plaque index is calculated by assigning a score to each surface based on the presence of plaque present, after probing. It is registered on the Mesial, Distal, buccal and palatal/lingual sides of the implant. Scores are reported dichotomously. It categorizes plaque as either present or absent, using a binary scoring system: 1: Presence of plaque 0: Absence of plaque A higher overall plaque score could indicate a worse outcome with a higher risk of inflammation of the tissues surrounding the implant. |
| Measure | Description | Time Frame |
|---|---|---|
| Suppuration | Presence or Absence were noted (qualitatively) 15 seconds after probing test. | It's assessed at the 4 week follow-up appointment. |
| Irritation, Pain and Discomfort | These are subjective outcomes reported by the patient by a questionnaire sent to them. Patients have to indicate from a scale of 0 to 10 :
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Mouradian, DMD, MSc, FRCD(C), Dip.ABP | Laval University | Study Director |
| Beatrice Groleau-Asselin, DMD, MSc, FRCD(C) | Laval University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculté de Médecine dentaire de l'Université Laval | Québec | Quebec | G1V 0A6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21324383 | Background | Tamimi F, Le Nihouannen D, Bassett DC, Ibasco S, Gbureck U, Knowles J, Wright A, Flynn A, Komarova SV, Barralet JE. Biocompatibility of magnesium phosphate minerals and their stability under physiological conditions. Acta Biomater. 2011 Jun;7(6):2678-85. doi: 10.1016/j.actbio.2011.02.007. Epub 2011 Feb 13. | |
| 27280476 | Background |
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In the patient consent form, possible IPD sharing was not disclosed. This might be considered in future trial registrations.
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Test group: Received standard intervention and Gel intervention Control group: Received standard intervention
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| Mechanical Debridement | Procedure | Cleaning and scaling of the implant. |
|
| It is assessed on intervention day and at a 4 week- follow up appointment |
| Modified Gingival Index (MGI) | The testing was made similarly to the bleeding on probing, but also takes into consideration the visual evaluation of the tissues around the implant. The clinician focuses on detecting visual signs of inflammation, such as redness, swelling, and altered gingival contour. It is tested on the mesial, distal, buccal and palatal/lingual sides of the implant. Results are reported from a 0 to 4 scale with 0 indicating no bleeding and 4 indicating extreme inflammation with ulceration and tissue damage. | It is assessed on intervention day and at a 4 week- follow up appointment |
| Probing Depth | It is measured using a UNC15 periodontal probe. It is gently inserted into the sulcus or pocket surrounding the implant, following the contours of the implant and tissue. Care is taken to avoid excessive pressure, which could damage the delicate peri-implant tissue or lead to inaccurate readings. It is assessed at the mesial, distal, buccal and palatal/lingual sides. | It is assessed on intervention day and at a 4 week- follow up appointment |
| This was reported at 7 days post-op. |
| Laurenti M, Al Subaie A, Abdallah MN, Cortes AR, Ackerman JL, Vali H, Basu K, Zhang YL, Murshed M, Strandman S, Zhu J, Makhoul N, Barralet JE, Tamimi F. Two-Dimensional Magnesium Phosphate Nanosheets Form Highly Thixotropic Gels That Up-Regulate Bone Formation. Nano Lett. 2016 Aug 10;16(8):4779-87. doi: 10.1021/acs.nanolett.6b00636. Epub 2016 Jul 6. |
| 25123773 | Background | Figuero E, Graziani F, Sanz I, Herrera D, Sanz M. Management of peri-implant mucositis and peri-implantitis. Periodontol 2000. 2014 Oct;66(1):255-73. doi: 10.1111/prd.12049. |
| 39363547 | Background | Behmanesh S, Chow K, Dondani J, Al-Hashedi A, Tamimi F. Effectiveness of 2D magnesium phosphate hydrogel for surgical decontamination of dental implants: A case series. J Prosthodont. 2025 Jun;34(5):449-455. doi: 10.1111/jopr.13961. Epub 2024 Oct 3. |
| 27392811 | Background | Al-Hashedi AA, Laurenti M, Benhamou V, Tamimi F. Decontamination of titanium implants using physical methods. Clin Oral Implants Res. 2017 Aug;28(8):1013-1021. doi: 10.1111/clr.12914. Epub 2016 Jul 8. |