Glucosamine Periodontal Adjunctive Therapy

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02214095
• Other study ID #: randomized clinical trial
• Status: Terminated
• Phase: Phase 0
• First received: July 8, 2014
• Last updated: August 11, 2014
• Start date: January 2012
• Est. completion date: February 2013

Study information

• Verified date: July 2014
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 48 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

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
• lactose capsules

Locations

Country	Name	City	State
Egypt	Ainshams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gingival crevicular fluid IL-1ß level	baseline and after three months of Glucosamine Sulphate administration	0-3 months	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	gingival index	gingival inflammation was measured by gingival index at baseline and 3 months after drug administration.	0-3 months	Yes
Secondary	plaque index	plaque deposits was measured by plaque index at baseline and 3 months after drug therapy	0-3 months	Yes