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Completed

NCT Number: NCT04215432

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

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

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Key information

Conditions

Peri-implant Mucositis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Complutense de Madrid

Madrid, 28005, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Changes in bleeding on probing

    Time frame: baseline and 1-month follow-up

    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 outcomes

  1. Changes in probing depth

    Time frame: baseline and 1-month follow-up

    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).

  2. Changes in plaque index

    Time frame: baseline and 1-month follow-up

    It was recorded after using a disclosing dye, as the presence of dental plaque at the gingival margin at six sites in each implant.

  3. Changes in microbilogical sample

    Time frame: baseline and 1-month follow-up

    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.

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Collaborators

  • Bio Nature Essences S.L

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2020
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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