Glucosamine Periodontal Adjunctive Therapy

NCT ID: NCT02214095

Last Updated: 2014-08-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-02-28

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.

Conditions

Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

glucosamine sulphate capsules

500 mg Glucosamine Compound, three times daily for 3 months following initial cause related therapy.

Group Type: ACTIVE_COMPARATOR

glucosamine sulphate

Intervention Type: DRUG

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

lactose capsules three times daily for 3 months

Group Type: PLACEBO_COMPARATOR

lactose capsules

Intervention Type: DRUG

Interventions

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

Intervention Type: DRUG

lactose capsules

Intervention Type: DRUG

Other Intervention Names

antiarthritis drugs; antiinflammatory drugs

Eligibility 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mai Shafik Attia

lecturer of oral medicine and periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmaed Y Gamal

Role: PRINCIPAL_INVESTIGATOR

Ainshams University

Hala A Elela, professer

Role: PRINCIPAL_INVESTIGATOR

Ainshams University

Mai S Attia, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Locations

Ainshams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

randomized clinical trial

Identifier Type: -

Identifier Source: org_study_id