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

NCT02515929 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-08-05

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Oligomeric Proanthocyanidins

DIETARY_SUPPLEMENT

Placebo

Sponsors & Collaborators

  • University of Seville

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-12-31
Completion
2014-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02515929 on ClinicalTrials.gov