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

NCT04215432 | Completed FDA Device

• 1 other identifier: 0004
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peri-implant Mucositis

Keywords

dental implants; peri-implant mucosits; toothpaste; propolis; nanovitamin

Outcome Measures

Primary Outcomes (1)

• Changes in bleeding on probing

  It was present when it appeared bleeding at the gingival margin after recording probing depths at six sites in each implant. Modified bleeding index was also collected.

  baseline and 1-month follow-up

Secondary Outcomes (3)

• Changes in probing depth

  baseline and 1-month follow-up

• Changes in plaque index

  baseline and 1-month follow-up

• Changes in microbilogical sample

  baseline and 1-month follow-up

Study Arms (2)

Test group

EXPERIMENTAL

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%).

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

Placebo group

PLACEBO COMPARATOR

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.

Device: Placebo

Interventions

Gel containing propolis extract, nanovitamin C and nanovitamin E DEVICE

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.

Test group

Placebo DEVICE

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.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Bio Nature Essences S.L: collaborator

Study Sites (1)

Universidad Complutense de Madrid

Madrid, 28005, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 21, 2019
• First Posted: January 2, 2020
• Study Start: May 1, 2018
• Primary Completion: October 25, 2019
• Study Completion: December 21, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Locations

ES (1)