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

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ClinicalTrials.gov Identifier: NCT02767115
Recruitment Status : Completed
First Posted : May 10, 2016
Last Update Posted : May 10, 2016
Sponsor:
Information provided by (Responsible Party):
Mohammad Ramadan Rayyan, Riyadh Colleges of Dentistry and Pharmacy

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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Dietary Supplement: 2% GSE mucoadhesive gel Other: GSE free mucoadhesive gel Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Grape Seeds Extract Gel as an Adjunct to Scaling and Root Planing for the Treatment of Chronic Periodontitis: A Pilot Clinical Study
Study Start Date : February 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

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Arm Intervention/treatment
Experimental: GSE mucoadhesive gel
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
2% GSE mucoadhesive gel administered in periodontal pockets of GSE group at T0 and 3, 6, and 9 days after T0

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




Primary Outcome Measures :
  1. Change from baseline Pocket depth (PD) score [ Time Frame: before application of the gel (baseline T0), 4 weeks after first application (T1), 6 months after first application (T2) ]
    PD will be measured for all sites and compared with PD scores at T0


Secondary Outcome Measures :
  1. Change from baseline Plaque index (PI)score [ Time Frame: before application of the gel (baseline T0), 4 weeks after first application (T1), 6 months after first application (T2) ]
    PI will be measured for all sites and compared with PI scores at T0

  2. Change from baseline Gingival index (GI)score [ Time Frame: before application of the gel (baseline T0), 4 weeks after first application (T1), 6 months after first application (T2) ]
    GI will be measured for all sites and compared with GI scores at T0

  3. Change from baseline Bleeding on probing (BOP) [ Time Frame: before application of the gel (baseline T0), 4 weeks after first application (T1), 6 months after first application (T2) ]
    BOP will be examined for all sites and number of sites with positive BOP will be compared with number of sites with positive BOP at T0



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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02767115


Locations
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Saudi Arabia
Riyadh colleges of dentistry and pharmacy
Riyadh, Saudi Arabia, 11681
Sponsors and Collaborators
Riyadh Colleges of Dentistry and Pharmacy
Investigators
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Principal Investigator: Mohammad Rayyan, MDS Assistant professor
Principal Investigator: Tammam S Terkawi, MSc Lecturer

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Responsible Party: Mohammad Ramadan Rayyan, Assistant professor, Riyadh Colleges of Dentistry and Pharmacy
ClinicalTrials.gov Identifier: NCT02767115     History of Changes
Other Study ID Numbers: FUGRP/2014/182
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Chronic Periodontitis
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Grape Seed Extract
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs