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

NCT ID: NCT04215432

Last Updated: 2020-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-12-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peri-implant Mucositis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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%).

Group Type EXPERIMENTAL

Gel containing propolis extract, nanovitamin C and nanovitamin E

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bio Nature Essences S.L

UNKNOWN

Sponsor Role collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rosa María López-Pintor Muñoz

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidad Complutense de Madrid

Madrid, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0004

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dental Implants and Mouth Rinse
NCT02002442 COMPLETED PHASE2