Clinical trial NCT02214095: Glucosamine Periodontal Adjunctive Therapy
Official title: Glucosamine Sulphate as an Adjunctive Therapy to Closed Mechanical Debridement Reduced Gingival Cervicular Fluid IL-1β in Patients With Chronic Periodontitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Chronic Periodontitis
Keywords: Cytokines
interleukin-1β
chronic periodontitis
host modulation
glucosamine sulphate.
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2014-08-12
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: gingival crevicular fluid IL-1β level
timeFrame: 0-3 months
Secondary outcomes:
measure: probing depth
timeFrame: 0-3 months
measure: clinical attachment level
timeFrame: 0-3 months
measure: gingival index
timeFrame: 0-3 months
measure: plaque index
timeFrame: 0-3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams University
Study officials:
affiliation: Ainshams University
name: Ahmaed Y Gamal
role: PRINCIPAL_INVESTIGATOR
affiliation: Ainshams University
name: Hala A Elela, professer
role: PRINCIPAL_INVESTIGATOR
affiliation: Al-Azhar University
name: Mai S Attia, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: