Propolis Extract, Nanovitamin C and Nanovitamin E in Peri-implant Mucositis

Universidad Complutense de Madrid

Status: Completed

Conditions: Peri-implant Mucositis

Treatments: Device: Gel containing propolis extract, nanovitamin C and nanovitamin E; Device: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04215432

0004

Details and patient eligibility

About

The objective of this study was to perform the first clinical trial to evaluate the effectiveness of propolis extract, nanovitamin C and nanovitamin E gel as adjuvant to mechanical debridement in clinical and microbiological parameters of implants with peri-implant mucositis

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• cooperative adult patients,
• with one or more implants with peri-implant mucositis, and
• presenting at least 18 months of functional loading.

Exclusion criteria

• refuse to participate in the study,
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups, including a placebo group

Test group

Experimental group

Description:

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%).

Treatment:

Device: Gel containing propolis extract, nanovitamin C and nanovitamin E

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Device: Placebo