Glucosamine Periodontal Adjunctive Therapy

NCT02214095 | Terminated Early Phase 1 DMC

• 1 other identifier: randomized clinical trial
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Periodontitis

Keywords

Cytokines; interleukin-1β; chronic periodontitis; host modulation; glucosamine sulphate.

Outcome Measures

Primary Outcomes (1)

• gingival crevicular fluid IL-1β level

  baseline and after three months of Glucosamine Sulphate administration

  0-3 months

Secondary Outcomes (4)

• probing depth

  0-3 months

• clinical attachment level

  0-3 months

• gingival index

  0-3 months

• plaque index

  0-3 months

Study Arms (2)

glucosamine sulphate capsules

ACTIVE COMPARATOR

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

Drug: glucosamine sulphate

lactose capsules

PLACEBO COMPARATOR

lactose capsules three times daily for 3 months

Drug: lactose capsules

Interventions

glucosamine sulphate 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

Also known as: antiarthritis drugs, antiinflammatory drugs

glucosamine sulphate capsules

lactose capsules DRUG

lactose capsules

Eligibility Criteria

• Age: 35 Years - 48 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• good compliance with the plaque control instructions following initial therapy
• each subject contributed a single premolar or molar tooth with interproximal probing depth ≥ 5 mm and clinical attachment loss ≥ 4 mm
• teeth involved were all vital with score 0-1 mobility
• availability for the follow-up and maintenance program;

You may not qualify if:

• no systemic diseases which could influence the outcome of therapy as evidenced by Burket's Oral Medicine health history questionnaire
• absence of periodontal treatment for the previous year
• absence of systemic medication or antibiotic treatment for the previous six months
• absence of a smoking habit.
• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams University

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Glucosamine; Lactose

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexosamines; Amino Sugars; Carbohydrates; Disaccharides; Oligosaccharides; Polysaccharides; Sugars

Study Officials

• Ahmaed Y Gamal

  Ainshams University

  PRINCIPAL INVESTIGATOR

• Hala A Elela, professer

  Ainshams University

  PRINCIPAL INVESTIGATOR

• Mai S Attia, Lecturer

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of oral medicine and periodontology

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: August 12, 2014
• Study Start: January 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: August 12, 2014

Record last verified: 2014-07

Locations

EG (1)