Back to resultsGlucosamine Periodontal Adjunctive Therapy
Primary Purpose
Chronic Periodontitis
Status
Terminated
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
glucosamine sulphate
lactose capsules
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis focused on measuring Cytokines, interleukin-1β, chronic periodontitis, host modulation, glucosamine sulphate.
Eligibility Criteria
Inclusion Criteria:
- good compliance with the plaque control instructions following initial therapy
- each subject contributed a single premolar or molar tooth with interproximal probing depth ≥ 5 mm and clinical attachment loss ≥ 4 mm
- teeth involved were all vital with score 0-1 mobility
- availability for the follow-up and maintenance program;
Exclusion Criteria:
- no systemic diseases which could influence the outcome of therapy as evidenced by Burket's Oral Medicine health history questionnaire
- absence of periodontal treatment for the previous year
- absence of systemic medication or antibiotic treatment for the previous six months
- absence of a smoking habit.
- post menopausal, pregnant or breast feeding women were excluded from participating in the study. Patients with contraindications to glucosamine sulphate therapy e.g., hypersensitivity to any of the product's components or with inadequate compliance with the oral hygiene maintenance schedule were also excluded from the study.
Sites / Locations
- Ainshams University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
glucosamine sulphate capsules
lactose capsules
Arm Description
500 mg Glucosamine Compound, three times daily for 3 months following initial cause related therapy.
lactose capsules three times daily for 3 months
Outcomes
Primary Outcome Measures
gingival crevicular fluid IL-1β level
baseline and after three months of Glucosamine Sulphate administration
Secondary Outcome Measures
probing depth
the distance from the gingival margin to the base of the pocket was measured at baseline and 3 months after drug administration
clinical attachment level
distance from cemento-enamel junction and base of the pocket was measured at baseline and 3 months after drug administration
gingival index
gingival inflammation was measured by gingival index at baseline and 3 months after drug administration.
plaque index
plaque deposits was measured by plaque index at baseline and 3 months after drug therapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02214095
Brief Title
Glucosamine Periodontal Adjunctive Therapy
Official Title
Glucosamine Sulphate as an Adjunctive Therapy to Closed Mechanical Debridement Reduced Gingival Cervicular Fluid IL-1β in Patients With Chronic Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Why Stopped
had been finished
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is the first evidence based work evaluated the systemic use of glucosamine as an adjunctive therapy to closed mechanical debridement in chronic periodontitis. The use of glucosamine sulphate was correlated with clinical outcomes and IL1-β level in the GCF of patients with moderate to advanced chronic periodontitis
Detailed Description
Targeting the inflammatory response may be a rational approach to the medical treatment of chronic periodontitis. Glucosamine sulphate (GS) was proven to have anti-inflammatory actions with minimal side effect profile. Objectives; The main objectives of this study were to evaluate clinically the efficacy of GS; as a novel adjunctive host modulating agent in periodontal therapy and to investigate its effect on gingival crevicular fluid (GCF) level of IL-1β. Methods; Forty patients with moderate to severe chronic periodontitis (CP) were included in this study. They were randomly divided into two groups. Group I (G1) patients (n=20) received 500 mg GS capsules three times daily for 3 months following full mouth scaling and root planing (SRP), while group II (G2) patients (n=20) received a placebo for the same period following full mouth SRP. Clinical periodontal parameters and GCF IL-1β levels were analyzed at baseline and 3 months following therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Cytokines, interleukin-1β, chronic periodontitis, host modulation, glucosamine sulphate.
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
glucosamine sulphate capsules
Arm Type
Active Comparator
Arm Description
500 mg Glucosamine Compound, three times daily for 3 months following initial cause related therapy.
Arm Title
lactose capsules
Arm Type
Placebo Comparator
Arm Description
lactose capsules three times daily for 3 months
Intervention Type
Drug
Intervention Name(s)
glucosamine sulphate
Other Intervention Name(s)
antiarthritis drugs, antiinflammatory drugs
Intervention Description
group I (G1) patients received 500 mg glucosamine sulphate capsules (Glucosamine Compound) , three times daily for 3 months following initial cause related therapy. Group II patients were given placebo capsules( Lactose) for the same period following initial cause related therapy
Intervention Type
Drug
Intervention Name(s)
lactose capsules
Primary Outcome Measure Information:
Title
gingival crevicular fluid IL-1β level
Description
baseline and after three months of Glucosamine Sulphate administration
Time Frame
0-3 months
Secondary Outcome Measure Information:
Title
probing depth
Description
the distance from the gingival margin to the base of the pocket was measured at baseline and 3 months after drug administration
Time Frame
0-3 months
Title
clinical attachment level
Description
distance from cemento-enamel junction and base of the pocket was measured at baseline and 3 months after drug administration
Time Frame
0-3 months
Title
gingival index
Description
gingival inflammation was measured by gingival index at baseline and 3 months after drug administration.
Time Frame
0-3 months
Title
plaque index
Description
plaque deposits was measured by plaque index at baseline and 3 months after drug therapy
Time Frame
0-3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
good compliance with the plaque control instructions following initial therapy
each subject contributed a single premolar or molar tooth with interproximal probing depth ≥ 5 mm and clinical attachment loss ≥ 4 mm
teeth involved were all vital with score 0-1 mobility
availability for the follow-up and maintenance program;
Exclusion Criteria:
no systemic diseases which could influence the outcome of therapy as evidenced by Burket's Oral Medicine health history questionnaire
absence of periodontal treatment for the previous year
absence of systemic medication or antibiotic treatment for the previous six months
absence of a smoking habit.
post menopausal, pregnant or breast feeding women were excluded from participating in the study. Patients with contraindications to glucosamine sulphate therapy e.g., hypersensitivity to any of the product's components or with inadequate compliance with the oral hygiene maintenance schedule were also excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmaed Y Gamal
Organizational Affiliation
Ainshams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hala A Elela, professer
Organizational Affiliation
Ainshams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mai S Attia, Lecturer
Organizational Affiliation
Al-Azhar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ainshams University
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Glucosamine Periodontal Adjunctive Therapy
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