Glucosamine Sulphate Versus Ginger in Non-Surgical Periodontal Therapy

NCT06200415 | Completed Phase 2 DMC

• 1 other identifier: FDASU-Rec IM012013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Glucosamine (GlcN) is an N-deacetyl amino monosaccharide sugar derived from complete hydrolysis of chitosan in which it is important vector for chondroitin and keratin sulfate, while on the other hand, medicinal plants became a source of great economic benefit worldwide, ginger has been found to have biological activities such as antioxidant, anti-inflammatory, antimicrobial, and anticancer activities. So, these effects which made it a good candidate to be used in periodontal therapy. The main objective of this study is to assess and compare the effect of locally delivered glucosamine sulphate gel versus ginger gel on the clinical parameters in periodontitis patients including Plaque index (PI), Means sulcus bleeding index (MSBI), Probing depth (PD), Clinical attachment loss (CAL). and to detect the effect of locally delivered both gels on RANKL level in gingival crevicular fluid.

Conditions

Periodontal Pocket

Keywords

glucosamine sulphate; ginger; local delivery

Outcome Measures

Primary Outcomes (4)

• Assess the effect of locally delivered glucosamine sulphate gel versus ginger gel on Plaque index PI in periodontitis patients

  Assess the effect of locally delivered glucosamine sulphate gel versus ginger gel on Plaque index PI (0-3 score) in periodontitis patients

  1 month and three months

• Assess the effect of locally delivered glucosamine sulphate gel versus ginger gel on Mean Sulcus Bleeding Index MSBI in periodontitis patients

  Assess the effect of locally delivered glucosamine sulphate gel versus ginger gel on Mean Sulcus Bleeding Index MSBI (0-5 score) in periodontitis patients

  1 month and three months

• Assess the effect of locally delivered glucosamine sulphate gel versus ginger gel on Probing depth PD in periodontitis patients

  Assess the effect of locally delivered glucosamine sulphate gel versus ginger gel on Probing depth PD in millimeters in periodontitis patients

  1 month and three months

• Assess the effect of locally delivered glucosamine sulphate gel versus ginger gel on clinical attachment loss (cal) in periodontitis patients

  Assess the effect of locally delivered glucosamine sulphate gel versus ginger gel on clinical attachment loss (cal) in millimeters in periodontitis patients

  1 month and three months

Secondary Outcomes (1)

• 2. Detect the effect of locally delivered glucosamine sulphate and ginger gels on receptor activator nuclear factor kappa B ligand (RANKL) level in gingival crevicular fluid

  1 month and three months

Study Arms (2)

Glucosamine sulphate gel

EXPERIMENTAL

injecting about 2 mm of glucosamine sulphate gel in the affected periodontal pocket only once

Drug: Glucosamine Sulfate

ginger gel

EXPERIMENTAL

injecting about 2 mm of ginger gel in the affected periodontal pocket only once

Drug: Ginger Oil

Interventions

Glucosamine Sulfate DRUG

Glucosamine sulphate (GLcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of the chitosan with significant anti-inflammatory action.

Also known as: Glucosamine sulphate

Glucosamine sulphate gel

Ginger Oil DRUG

Ginger (Zingiber officinale Roscoe) has been found to have biological activities such as antioxidant, anti-inflammatory, antimicrobial, and anticancer activities.

Also known as: Ginger, Zingiber officinale, Zingiber genus

ginger gel

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Localized periodontitis, probing depth ≥5 mm. Less than 30% of teeth are involved.
• Age ranging from 25 to 50 years.
• Good compliance with the plaque control instructions following initial therapy.
• Availability for follow up and maintenance program.
• Systemically free according to the American Society of Anesthesiologists (ASA I).

You may not qualify if:

• Smokers
• Systemic diseases which could influence the outcome of the therapy (According to Cornell Medical Index-Health Questionnaire).
• Pregnant and lactating females.
• Vulnerable groups of patients' e.g. (prisoners, handicapped patients and decision ally impaired individuals).
• Unwilling patients to perform oral hygiene measures of plaque control.
• Patients with a history of allergy against any components of the two materials.
• Previous Periodontal treatment or any use of antibiotic/anti-inflammatory drugs within the last 6 months before the initiation of the study

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Related Links

• Clinical effect of subgingivally delivered simvastatin in the treatment of patients with chronic periodontitis: a randomized clinical trial
• Chondroitin and glucosamine sulfate in combination decrease the pro-resorptive properties of human osteoarthritis subchondral bone osteoblasts: a basic science study
• Gingerdione A, a polyphenol present in ginger, suppresses obesity and adipose tissue inflammation in high-fat diet-fed mice
• 6-Paradol and 6-Shogaol, the Pungent Compounds of Ginger, Promote Glucose Utilization in Adipocytes and Myotubes, and 6-Paradol Reduces Blood Glucose in High-Fat Diet-Fed Mice
• Edible ginger-derived nanoparticles: A novel therapeutic approach for the prevention and treatment of inflammatory bowel disease and colitis-associated cancer

MeSH Terms

Conditions

Periodontal Pocket

Interventions

Glucosamine; ginger extract

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hexosamines; Amino Sugars; Carbohydrates

Study Officials

• Hala A. Abuel Ela, professor

  Faculty of dentistry- Ain Shams University

  STUDY DIRECTOR

• Olfat G. Shaker, professor

  Cairo University

  STUDY DIRECTOR

• Dina A. Othman, professor

  Faculty of pharmacy- Azhar University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post graduate student, department of Oral Medicine, Periodontology, Oral Diagnosis and Radiology, Faculty of Dentistry, Ain Shams University, Egypt)

Model Details: supra and sub gingival scaling will be performed to all patients followed by application of local delivery drug within two groups to assess the effects after 1 month then 3 months.

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 11, 2024
• Study Start: November 8, 2022
• Primary Completion: June 30, 2023
• Study Completion: August 8, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

EG (1)