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

Peri-implant Mucositis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04215432
• Other study ID #: 0004
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: December 21, 2019

Study information

• Verified date: December 2019
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 21, 2019
• Est. primary completion date: October 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis

Intervention

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
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.

Locations

Country	Name	City	State
Spain	Universidad Complutense de Madrid	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Bio Nature Essences S.L

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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