Grape Seeds Extract Gel as an Adjunct for the Treatment of Chronic Periodontitis

NCT02767115 | Completed Phase 2

• 1 other identifier: FUGRP/2014/182
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to formulate a mucoadhesive gel of grapes seed extract (GSE) followed by short-term clinical study for the effectiveness of this gel onto the pocket depth (PD), plaque index (PI), gingival index (GI), and bleeding on probing (BOP) when applied in periodontal pockets as an adjunct treatment for chronic periodontitis.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• Change from baseline Pocket depth (PD) score

  PD will be measured for all sites and compared with PD scores at T0

  before application of the gel (baseline T0), 4 weeks after first application (T1), 6 months after first application (T2)

Secondary Outcomes (3)

• Change from baseline Plaque index (PI)score

  before application of the gel (baseline T0), 4 weeks after first application (T1), 6 months after first application (T2)

• Change from baseline Gingival index (GI)score

  before application of the gel (baseline T0), 4 weeks after first application (T1), 6 months after first application (T2)

• Change from baseline Bleeding on probing (BOP)

  before application of the gel (baseline T0), 4 weeks after first application (T1), 6 months after first application (T2)

Study Arms (2)

GSE mucoadhesive gel

EXPERIMENTAL

2%GSE mucoadhesive gel administered in the periodontal pockets of GSE group at T0 and 3, 6, and 9 days after T0

Dietary Supplement: 2% GSE mucoadhesive gel

Control mucoadhesive gel

PLACEBO COMPARATOR

GSE free mucoadhesive gel administered in the periodontal pockets of Control group at T0 and 3, 6, and 9 days after T0

Other: GSE free mucoadhesive gel

Interventions

2% GSE mucoadhesive gel DIETARY_SUPPLEMENT

2% GSE mucoadhesive gel administered in periodontal pockets of GSE group at T0 and 3, 6, and 9 days after T0

GSE mucoadhesive gel

GSE free mucoadhesive gel OTHER

GSE free mucoadhesive gel administered in periodontal pockets of Control group at T0 and 3, 6, and 9 days after T0

Control mucoadhesive gel

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• being medically fit
• non-smokers
• has clinical diagnosis of chronic periodontitis with pockets depth of 5mm or greater along with evident radiographic bone Loss, and acceptance to provide an informed consent

You may not qualify if:

• pregnant patients
• breastfeeding mothers
• patients who are taking dietary supplements
• patients known to have grape's allergy
• patients with hypertension or bleeding disorders
• patients who have been under systemic or topical antibiotic treatments in the last 3 months
• smokers, and patients who are taking any medications that may interact with GSE

Sponsors & Collaborators

• Riyadh Colleges of Dentistry and Pharmacy: lead

Study Sites (1)

Riyadh colleges of dentistry and pharmacy

Riyadh, Riyadh Region, 11681, Saudi Arabia

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammad Rayyan, MDS

  Assistant professor

  PRINCIPAL INVESTIGATOR

• Tammam S Terkawi, MSc

  Lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 10, 2016
• Study Start: February 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 10, 2016

Record last verified: 2016-05

Locations

SA (1)