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Glucosamine Periodontal Adjunctive Therapy

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ClinicalTrials.gov Identifier: NCT02214095
Recruitment Status : Terminated (had been finished)
First Posted : August 12, 2014
Last Update Posted : August 12, 2014
Sponsor:
Information provided by (Responsible Party):
Mai Shafik Attia, Ain Shams University

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

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: glucosamine sulphate Drug: lactose capsules Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Glucosamine Sulphate as an Adjunctive Therapy to Closed Mechanical Debridement Reduced Gingival Cervicular Fluid IL-1β in Patients With Chronic Periodontitis
Study Start Date : January 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: glucosamine sulphate capsules
500 mg Glucosamine Compound, three times daily for 3 months following initial cause related therapy.
Drug: glucosamine sulphate
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
Other Names:
  • antiarthritis drugs
  • antiinflammatory drugs

Placebo Comparator: lactose capsules
lactose capsules three times daily for 3 months
Drug: lactose capsules



Primary Outcome Measures :
  1. gingival crevicular fluid IL-1β level [ Time Frame: 0-3 months ]
    baseline and after three months of Glucosamine Sulphate administration


Secondary Outcome Measures :
  1. probing depth [ Time Frame: 0-3 months ]
    the distance from the gingival margin to the base of the pocket was measured at baseline and 3 months after drug administration

  2. clinical attachment level [ Time Frame: 0-3 months ]
    distance from cemento-enamel junction and base of the pocket was measured at baseline and 3 months after drug administration

  3. gingival index [ Time Frame: 0-3 months ]
    gingival inflammation was measured by gingival index at baseline and 3 months after drug administration.

  4. plaque index [ Time Frame: 0-3 months ]
    plaque deposits was measured by plaque index at baseline and 3 months after drug therapy



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Ages Eligible for Study:   35 Years to 48 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. good compliance with the plaque control instructions following initial therapy
  2. each subject contributed a single premolar or molar tooth with interproximal probing depth ≥ 5 mm and clinical attachment loss ≥ 4 mm
  3. teeth involved were all vital with score 0-1 mobility
  4. availability for the follow-up and maintenance program;

Exclusion Criteria:

  1. no systemic diseases which could influence the outcome of therapy as evidenced by Burket's Oral Medicine health history questionnaire
  2. absence of periodontal treatment for the previous year
  3. absence of systemic medication or antibiotic treatment for the previous six months
  4. absence of a smoking habit.
  5. 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.

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): NCT02214095


Locations
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Egypt
Ainshams University
Cairo, Egypt, 11566
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Ahmaed Y Gamal Ainshams University
Principal Investigator: Hala A Elela, professer Ainshams University
Principal Investigator: Mai S Attia, Lecturer Al-Azhar University

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Responsible Party: Mai Shafik Attia, lecturer of oral medicine and periodontology, Ain Shams University
ClinicalTrials.gov Identifier: NCT02214095     History of Changes
Other Study ID Numbers: randomized clinical trial
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: August 12, 2014
Last Verified: July 2014

Keywords provided by Mai Shafik Attia, Ain Shams University:
Cytokines
interleukin-1β
chronic periodontitis
host modulation
glucosamine sulphate.

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Inflammatory Agents