Propolis Extract, Nanovitamin C and Nanovitamin E in Peri-implant Mucositis
NCT ID: NCT04215432
Last Updated: 2020-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2018-05-01
2019-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Test group
Gel contained in tubes with the same appearance (30g), identical in colour, flavour and density, with the following components: Sodium-Monofluorophosphate, Silicon Dioxide, Glycerin, D-sorbitol, Polyethylene glycol, Sodium Carboxymethylcellulose, Xylitol, Sterol Glycoside, Peppermint Oil, L-Menthol, Methyl Hydroxybenzoate, Deionized Water, Propolis Extract (2%), Ascorbic Acid (0.2%) and Tocopherol Acetate (0.2%).
Gel containing propolis extract, nanovitamin C and nanovitamin E
The patient had to use the gel as a toothpaste and apply it with an interdental brush in mesial and distal aspects of the implant with peri-implant mucositis. during 1 month.
Placebo group
Gel contained in tubes with the same appearance (30g), identical in colour, flavour and density, with the following components: Sodium-Monofluorophosphate, Silicon Dioxide, Glycerin, D-sorbitol, Polyethylene glycol, Sodium Carboxymethylcellulose, Xylitol, Sterol Glycoside, Peppermint Oil, L-Menthol, Methyl Hydroxybenzoate, Deionized Water and E155/151 coloring.
Placebo
The patient had to use the gel as a toothpaste and apply it with an interdental brush in mesial and distal aspects of the implant with peri-implant mucositis.
Interventions
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Gel containing propolis extract, nanovitamin C and nanovitamin E
The patient had to use the gel as a toothpaste and apply it with an interdental brush in mesial and distal aspects of the implant with peri-implant mucositis. during 1 month.
Placebo
The patient had to use the gel as a toothpaste and apply it with an interdental brush in mesial and distal aspects of the implant with peri-implant mucositis.
Eligibility Criteria
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Inclusion Criteria
* with one or more implants with peri-implant mucositis, and
* presenting at least 18 months of functional loading.
Exclusion Criteria
* patients who had implants with peri-implantitis (BOP and/or suppuration together with progressive radiographic marginal bone loss),
* patients with uncontrolled periodontitis (presence of nine or more sites with PD ≥ 5 mm and with full-mouth bleeding score (FMBS) \> 25%),
* systemic diseases or conditions that could alter the results of the study (diabetes mellitus, immunosuppression, infectious diseases, rheumatoid disease, history of bisphosphonate treatment, radiotherapy, chemotherapy, etc.),
* patients who had taken local and/or systemic antibiotics less than 2 months ago,
* pregnant or breastfeeding women, and
* patients with history of allergies to the test and/or placebo components administered.
18 Years
ALL
No
Sponsors
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Bio Nature Essences S.L
UNKNOWN
Universidad Complutense de Madrid
OTHER
Responsible Party
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Rosa María López-Pintor Muñoz
Associate professor
Locations
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Universidad Complutense de Madrid
Madrid, , Spain
Countries
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Other Identifiers
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0004
Identifier Type: -
Identifier Source: org_study_id
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