Glucosamine Periodontal Adjunctive Therapy

Early Phase 1TerminatedNCT02214095

Ain Shams University40 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Periodontitis

Interventions

glucosamine sulphateDRUG

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 capsulesDRUG

Eligibility

Sex: ALLMin age: 35 YearsMax age: 48 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Ainshams University

Cairo, Egypt

Outcomes

Primary Outcomes

gingival crevicular fluid IL-1β level

baseline and after three months of Glucosamine Sulphate administration

Time frame: 0-3 months

Secondary Outcomes

probing depth

the distance from the gingival margin to the base of the pocket was measured at baseline and 3 months after drug administration

Time frame: 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

Time frame: 0-3 months

gingival index

gingival inflammation was measured by gingival index at baseline and 3 months after drug administration.

Time frame: 0-3 months

plaque index

plaque deposits was measured by plaque index at baseline and 3 months after drug therapy

Time frame: 0-3 months

Data from ClinicalTrials.gov

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