Glucosamine Periodontal Adjunctive Therapy

Glucosamine Sulphate as an Adjunctive Therapy to Closed Mechanical Debridement Reduced Gingival Cervicular Fluid IL-1β in Patients With Chronic Periodontitis

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

Study Overview

• Status: Terminated
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Drug: glucosamine sulphate; Drug: lactose capsules

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11566
    • Ainshams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gingival crevicular fluid IL-1β level	baseline and after three months of Glucosamine Sulphate administration	0-3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
probing depth	the distance from the gingival margin to the base of the pocket was measured at baseline and 3 months after drug administration	0-3 months
clinical attachment level	distance from cemento-enamel junction and base of the pocket was measured at baseline and 3 months after drug administration	0-3 months
gingival index	gingival inflammation was measured by gingival index at baseline and 3 months after drug administration.	0-3 months
plaque index	plaque deposits was measured by plaque index at baseline and 3 months after drug therapy	0-3 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Ahmaed Y Gamal, Ainshams university; Principal Investigator: Hala A Elela, professer, Ainshams university; Principal Investigator: Mai S Attia, Lecturer, Al-Azhar University

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: July 8, 2014
• First Submitted That Met QC Criteria: August 11, 2014
• First Posted (Estimate): August 12, 2014

Study Record Updates

• Last Update Posted (Estimate): August 12, 2014
• Last Update Submitted That Met QC Criteria: August 11, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Cytokines; chronic periodontitis; interleukin-1β; host modulation; glucosamine sulphate.
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Anti-Inflammatory Agents
• Other Study ID Numbers: randomized clinical trial