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

Effect of Propolis Extract, Nanovitamin C and Nanovitamin E in Clinical and Microbiological Parameters of Peri-implant Mucositis: A Double-blind, Randomized, Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Peri-implant Mucositis
• Intervention / Treatment: Device: Gel containing propolis extract, nanovitamin C and nanovitamin E; Device: Placebo

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28005
    • Universidad Complutense de Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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%).	Device: 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_COMPARATOR: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in probing depth	It was recorded at six sites of each implant with PM, using a probe with a force of 0.2N (PCV12; HuFriedy, Chicago, IL, EEUU).	baseline and 1-month follow-up
Changes in plaque index	It was recorded after using a disclosing dye, as the presence of dental plaque at the gingival margin at six sites in each implant.	baseline and 1-month follow-up
Changes in microbilogical sample	Microbiological samples were obtained at the deepest peri-implant pocket. Firstly, the area was isolated using cotton rolls and dried with a gentle air blow. Then, three sterile paper tips (#30, Maillefer, Ballaigues, Switzerland) were left for 10 seconds at the point with the greatest peri-implant pocket depth. Finally, the papers were introduced in a vial containing 1.5 ml of reduced transport fluid. The vials were sent to the microbiology laboratory of the School of Dentistry, at Complutense University of Madrid for an anaerobic culture within 24 hours. Total counts and counts of target periodontal pathongens [Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia, Parvimonas micra, Fusobacterium nucleatum, Campylobacter rectus, Eikenella corrodens, Capnocytophaga sp., Actinomyces odontolyticus] were determined after 7-14 days of anaerobic incubation. Then, those results were converted in colony-forming units per ml.	baseline and 1-month follow-up

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Collaborators: Bio Nature Essences S.L

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2018
• Primary Completion (ACTUAL): October 25, 2019
• Study Completion (ACTUAL): December 21, 2019

Study Registration Dates

• First Submitted: December 21, 2019
• First Submitted That Met QC Criteria: December 31, 2019
• First Posted (ACTUAL): January 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 31, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: dental implants; propolis; toothpaste; peri-implant mucosits; nanovitamin
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Anti-Infective Agents; Propolis
• Other Study ID Numbers: 0004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes