NCT02515929

Prospective Double-Blind Randomized Controlled Clinical Trial in the Gingivitis Prevention With an Oligomeric Proanthocyanidins Nutritional Supplement

Completed Phase 4 Last updated 4 August 2015

What this trial tests

Phase 4 trial testing Oligomeric Proanthocyanidins in Gingivitis in 20 participants. Completed in 1 February 2014.

Timeline

1 September 2013

Primary endpoint
1 December 2013

1 February 2014

Quick facts

Lead sponsor	University of Seville
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	20
Start date	1 September 2013
Primary completion	1 December 2013
Estimated completion	1 February 2014

Drugs / interventions tested

• Oligomeric Proanthocyanidins
• Placebo

Conditions studied

• Gingivitis — all drugs for Gingivitis →

Sponsor

University of Seville

Who can join

Adults 18 to 50, any sex, with Gingivitis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Silness and Löe index
  Time frame: 21days
  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.
• Gingival Bleeding index
  Time frame: 21 days
  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
• Turesky Plaque Index
  Time frame: 21 days
  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
• Inflammatory crevicular fluid study (IL6)
  Time frame: 21 days
  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
• Brightness of the Gingiva
  Time frame: 21 days
  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.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Proanthocyanidins and hydrolysable tannins: occurrence, dietary intake and pharmacological effects.
   Smeriglio A, Barreca D, Bellocco E, Trombetta D. · · 2017 · cited 323× · PMID 27646690 · DOI 10.1111/bph.13630
2. A Prospective, Double-Blind, Randomized, Controlled Clinical Trial in the Gingivitis Prevention with an Oligomeric Proanthocyanidin Nutritional Supplement.
   Díaz Sánchez RM, Castillo-Dalí G, Fernández-Olavarría A, Mosquera-Pérez R, et al · · 2017 · cited 11× · PMID 29375198 · DOI 10.1155/2017/7460780