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

Universidad Complutense de Madrid46 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Peri-implant Mucositis

Interventions

Gel containing propolis extract, nanovitamin C and nanovitamin EDEVICE

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.

PlaceboDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Universidad Complutense de Madrid

Madrid, Spain

Outcomes

Primary Outcomes

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.

Time frame: baseline and 1-month follow-up

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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.

Time frame: baseline and 1-month follow-up

Data from ClinicalTrials.gov

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