Glucosamine Periodontal Adjunctive Therapy

Early Phase 1

Terminated

• Conditions: Chronic Periodontitis
• Interventions: Drug: lactose capsules; Drug: glucosamine sulphate

• Registration Number: NCT02214095
• Lead Sponsor: 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

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 Timeline

• Study Start: 2012-01
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2014-07
• Study First Submitted: 2014-07-08
• Study First Submitted QC: 2014-08-11
• Last Update Submitted: 2014-08-11
• Study First Posted: 2014-08-12
• Last Update Posted: 2014-08-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lactose capsules	lactose capsules	lactose capsules three times daily for 3 months
glucosamine sulphate capsules	glucosamine sulphate	500 mg Glucosamine Compound, three times daily for 3 months following initial cause related therapy.

Primary Outcome Measures

Name	Time	Method
gingival crevicular fluid IL-1β level	0-3 months	baseline and after three months of Glucosamine Sulphate administration

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ainshams University; 🇪🇬 Cairo, Egypt