Chronic PeriodontitisEarly Phase 1NCT02214095
Glucosamine Periodontal Adjunctive Therapy
A Early Phase 1 study testing glucosamine sulphate and lactose capsules in people with Chronic Periodontitis, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 48 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- glucosamine sulphate and lactose capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2012to Feb 2013
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 48 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glucosamine Sulphate as an Adjunctive Therapy to Closed Mechanical Debridement Reduced Gingival Cervicular Fluid IL-1β in Patients With Chronic Periodontitis
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
Read the 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
- Being tested
- glucosamine sulphate, lactose capsules
- Keywords
- Cytokines, interleukin-1β, chronic periodontitis, host modulation, glucosamine sulphate.
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucosamine sulphateDrug
Also called antiarthritis drugs, antiinflammatory drugs
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
| Study group | Role | What they receive |
|---|---|---|
| glucosamine sulphate capsules | Active comparator | 500 mg Glucosamine Compound, three times daily for 3 months following initial cause related therapy. Receives: Drug: glucosamine sulphate |
| lactose capsules | Placebo comparator | lactose capsules three times daily for 3 months Receives: Drug: lactose capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
gingival crevicular fluid IL-1β level
baseline and after three months of Glucosamine Sulphate administration
Measured: 0-3 months
Secondary outcomes (4)
probing depth
the distance from the gingival margin to the base of the pocket was measured at baseline and 3 months after drug administration
Measured: 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
Measured: 0-3 months
gingival index
gingival inflammation was measured by gingival index at baseline and 3 months after drug administration.
Measured: 0-3 months
plaque index
plaque deposits was measured by plaque index at baseline and 3 months after drug therapy
Measured: 0-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startJan 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: had been finished
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Shafik Attia, Ain Shams University
- Investigators
- Ahmaed Y Gamal, Principal investigator, Ainshams UniversityHala A Elela, professer, Principal investigator, Ainshams UniversityMai S Attia, Lecturer, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214095
- Sponsor's protocol ID
- randomized clinical trial
- Status last verified
- Jul 2014
- First submitted
- 8 Jul 2014
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucosamine Sulphate as an Adjunctive Therapy to Closed Mechanical Debridement Reduced Gingival Cervicular Fluid IL-1β in Patients With Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT02214095
- Acronym / sponsor ID
- randomized clinical trial
- Conditions
- Chronic Periodontitis
- Keywords
- Cytokines, interleukin-1β, chronic periodontitis, host modulation, glucosamine sulphate.
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: had been finished
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 12 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glucosamine sulphate capsules | Active comparator | Drug: glucosamine sulphate500 mg Glucosamine Compound, three times daily for 3 months following initial cause related therapy. |
| lactose capsules | Placebo comparator | Drug: lactose capsuleslactose capsules three times daily for 3 months |
Who may qualify
- Ages
- 35 to 48 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glucosamine sulphateAlso: antiarthritis drugs, antiinflammatory drugsgroup 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 | Drug | glucosamine sulphate capsules |
| lactose capsules | Drug | lactose capsules |
Primary outcome
gingival crevicular fluid IL-1β level
Time frame: 0-3 months
baseline and after three months of Glucosamine Sulphate administration
4 secondary outcomes
probing depth
Time frame: 0-3 months
clinical attachment level
Time frame: 0-3 months
gingival index
Time frame: 0-3 months
plaque index
Time frame: 0-3 months
Results and safety
The study was stopped early (reason given: had been finished). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmaed Y Gamal principal investigator
Ainshams University
Hala A Elela, professer principal investigator
Ainshams University
Mai S Attia, Lecturer principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing glucosamine sulphate and lactose capsules in people with Chronic Periodontitis, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: had been finished). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gingival crevicular fluid IL-1β level (time frame: 0-3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2014.