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

Primary Purpose

Peri-implant Mucositis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Gel containing propolis extract, nanovitamin C and nanovitamin E
Placebo
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-implant Mucositis focused on measuring dental implants, peri-implant mucosits, toothpaste, propolis, nanovitamin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Universidad Complutense de Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Test group

Placebo group

Arm 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%).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.

Full Information

First Posted
December 21, 2019
Last Updated
December 31, 2019
Sponsor
Universidad Complutense de Madrid
Collaborators
Bio Nature Essences S.L
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1. Study Identification

Unique Protocol Identification Number
NCT04215432
Brief Title
Propolis Extract, Nanovitamin C and Nanovitamin E in Peri-implant Mucositis
Official Title
Effect of Propolis Extract, Nanovitamin C and Nanovitamin E in Clinical and Microbiological Parameters of Peri-implant Mucositis: A Double-blind, Randomized, Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
October 25, 2019 (Actual)
Study Completion Date
December 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
Collaborators
Bio Nature Essences S.L

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implant Mucositis
Keywords
dental implants, peri-implant mucosits, toothpaste, propolis, nanovitamin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Experimental
Arm 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%).
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Gel containing propolis extract, nanovitamin C and nanovitamin E
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in bleeding on probing
Description
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.
Time Frame
baseline and 1-month follow-up
Secondary Outcome Measure Information:
Title
Changes in probing depth
Description
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).
Time Frame
baseline and 1-month follow-up
Title
Changes in plaque index
Description
It was recorded after using a disclosing dye, as the presence of dental plaque at the gingival margin at six sites in each implant.
Time Frame
baseline and 1-month follow-up
Title
Changes in microbilogical sample
Description
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.
Time Frame
baseline and 1-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Universidad Complutense de Madrid
City
Madrid
ZIP/Postal Code
28005
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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