Prospective Double-Blind Randomized Controlled Clinical Trial in the Gingivitis Prevention With OPCs

NCT02515929 | Completed Phase 4 DMC

• 1 other identifier: USeville
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim: To evaluate the effectiveness on tissue response of the new nutritional supplement made of Oligomeric Proanthocyanidins (OPCs) in induced gingivitis after 21 days of use. Material and Methods: A double-blind randomized controlled prospective clinical trial was carried out on 20 patients divided into an experimental group treated with the OPCs pill and a control group treated with placebo, after fulfilling the selection criteria. Patients had to come 4 times during the study to register the Silness and Loe and Gingival Bleeding index, plaque index, inflammatory crevicular fluid study (IL6) and changes in brightness of the gingiva. No complementary hygiene methods were allowed during the 21 days.

Conditions

Gingivitis

Keywords

Oligomeric Proanthocyanidins; Periodontal Disease

Outcome Measures

Primary Outcomes (5)

• Silness and Löe index

  Six teeth were examined according to Ramfjord criteria (16-21-24-36-41-44 ). Four surfaces of each tooth were examined, making a total of 24 measurements taken.

  21days

• Gingival Bleeding index

  A periodontal probe was used to make this index. The values established for the examination are found below: 0 - Absence of inflammation. 1 - Mild inflammation, slight change in colour and no gingival edema. No bleeding on probing. 2 - Moderate inflammation, redness, edema and gingival hypertrophy. Bleeds to probe (after 10 seconds). 3 - Severe inflammation, marked redness and hypertrophy. There may be ulcerations. Tends to spontaneous bleeding.

  21 days

• Turesky Plaque Index

  The buccal surfaces of anterior teeth were examined using a mouthwash of basic fuchsine as developing agent plaque and a numerical scoring system from O to 5 was established. 0: There is no plaque 1: Independent streaks of plaque in the cervical margin of the tooth. 2: thin continuous band of plaque (up to 1mm) at the cervical margin. 3: Band greater than one millimetre wide, but covers less than one third of the crown. 4: The plate covers third but not more than two thirds of the crown. 5: The plate covers two thirds or more of the crown.

  21 days

• Inflammatory crevicular fluid study (IL6)

  Crevicular fluid samples were collected from interdental areas (lingual, buccal, mesial, and distal) of six teeth distributed by the four quadrants (16, 21, 24, 36, 41 and 44) by 5 strips of pressed paper 2cm long, especially for crevicular fluid. The impregnation time for each patient was 5 seconds and immediately inserted into 0.5ml Eppendorf microtubes with 50ul saline at 4 ° C for preservation. The sample transport to the biological laboratory was in a refrigerator, being stored frozen at -80°C at the laboratory until being processed.

  21 days

• Brightness of the Gingiva

  The brightness of the gingiva was taken to identify possible changes in the gingival colour. The reddening of the gingiva accompanies the inflammation of the tissue, which is a factor that may help to differentiate inflammatory changes at this level. The luminosity of the gingiva was registered with Micro SpectroShadeTM MHT Optic Research AG. This instrument is designed for taking dental colour. However, besides including colour guides, the SpectroShadeTM has the ability to measure the brightness of any colour, not just shades of white. The change in the colour of the gingiva was observed within the same patient measuring the reference colour for each patient in the same point in each evaluation visit and being able to compare the change in the coloration of the same point.

  21 days

Study Arms (2)

Oligomeric Proanthocyanidins

EXPERIMENTAL

90 mg exocian cran 408 plus 120mg Vitamin C, 1 tablet by mouth, every 24 hours for 21 days

Dietary Supplement: Oligomeric Proanthocyanidins

Placebo

PLACEBO COMPARATOR

Similar organoleptic experimental arm,1 tablet by mouth, every 24 hours for 21 days

Dietary Supplement: Placebo

Interventions

Oligomeric Proanthocyanidins DIETARY_SUPPLEMENT

Oligomeric Proanthocyanidins

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects older than 18 years, male or female, good general health, a minimum of 20 teeth (teeth that have gross caries, were crowned or extensively restored, orthodontic banded, abutments, or third molars were not included in the tooth count), signed informed consent before study initiation.

You may not qualify if:

• Periodontal disease, defined as 4 mm and / or positive bleeding on probing
• Pregnant or breastfeeding
• Subjects with fixed or removable prosthesis
• Tumor pathology in oral cavity; Use of antibiotics during 2 months period prior to the start of the trial; Hypersensitivity to red fruits in general; Xerostomia; Active Smoker; Contagious-infectious pathologies; Pathology with severe systemic repercussions; Any other judgment of the investigator if he believes endangers or risk to the subject participant; Subjects with phenylketonuria or allergy to aspartame; Use of any oral hygiene product for the duration of the study.

Sponsors & Collaborators

• University of Seville: lead

MeSH Terms

Conditions

Gingivitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DENTIST - MASTER STUDENT

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 5, 2015
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: August 5, 2015

Record last verified: 2015-08