Localized Aggressive PeriodontitisPhase 4NCT02402296
Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis
A Phase 4 study testing β-1,3/1,6-D-glucan in people with Localized Aggressive Periodontitis, run by Al-Azhar University.
Trial summary
combining the non-surgical therapy with a well-tolerated substance that can stimulate protective immune responses like B-glucan, might effectively mount resolution pathways contributing to resolving of the chronic lesion observed in aggressive forms of periodontal disease. Read more about this study
- Who is it for?
- Ages 20 to 27 years
- Conditions the study is for
- Localized Aggressive Periodontitis
- What is being tested?
- β-1,3/1,6-D-glucan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Aug 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 27 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Except for periodontitis, patients were systemically healthy as evaluated by modified Cornell medical index.
- No more than two teeth other than first molars and incisors, with probing depth (PD) ≥ 5mm, bleeding on probing (BOP), and clinical attachment level (CAL) ≥ 5mm.
- Rapid rate of attachment loss and bone destruction.
- A radiographic examination revealing an evidence of moderate to severe vertical bone loss around permanent incisors and first molar teeth.
- Every patient should have at least 20 teeth excluding third (3rd) molars, and at least an extraction-indicated tooth for a dento-periodontal affection.
- Familial aggregation.
Who cannot join
- Previous subgingival scaling and root planing, allergy to β-glucan, smoking, former smoking, pregnancy, need of antibiotic coverage for routine dental therapy, antibiotic therapy in the previous 6 months and allergy to chlorhexidine.
About this study
Official title: Efficacy of β-glucan in Treatment of Localized Aggressive Periodontitis: A Short Term Double-blinded, Placebo-controlled, Randomized Clinical Trial
combining the non-surgical therapy with a well-tolerated substance that can stimulate protective immune responses like B-glucan, might effectively mount resolution pathways contributing to resolving of the chronic lesion observed in aggressive forms of periodontal disease.
Read the detailed description
Aim: To investigate the efficacy of β-glucan supplementation to non-surgical periodontal therapy in localized aggressive periodontitis (LAP) patients.
Method: 30 subjects were randomly and equally assigned to receive scaling and root planing; either with placebo pills (Group I) or β-glucan (100 mg/once a day) (Group II), for 40 days. Subjects were clinically monitored on day 0 and day 91. Gingival samples were harvested from hopeless teeth sites to be investigated histologically and immunohistochemically using matrix metalloproteinase (MMP)-1 and 9 antibodies form each patient; at the same time intervals.
- Conditions
- Localized Aggressive Periodontitis
- Being tested
- β-1,3/1,6-D-glucan, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
β-1,3/1,6-D-glucanDrug
Also called Imurril capsules 100mg
15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days.
PlaceboOther
Also called Empty capsules filled with carbohydrates
15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days.
| Study group | Role | What they receive |
|---|---|---|
| Group II (test group) | Active comparator | Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing. Receives: Drug: β-1,3/1,6-D-glucan |
| Group I (control group) | Placebo comparator | Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Change in Clinical Attachment Level (CAL)
It is the distance from the base of the pocket till the cemento-enamel junction using Williams graduated probe
Measured: Day 0 and day 91 post therapy
Secondary outcomes (3)
Pocket Depth (PD)
It is the distance from the base of the pocket till the gingival margin using Williams graduated probe
Measured: Day 0 and day 91 post therapy
Gingival Index (GI)
Using the values of the gingival index according to (Loe \& Silness, 1963); 0-no bleeding on probing
- delayed bleeding on probing
- immediate bleeding on probing
- spontaneous bleeding
Measured: Day 0 and day 91 post therapy
Matrix Metallo-proteinase (MMP-1&9)
Their immuno-expression was assessed in the gingival samples harvested from the gingiva adjacent to hopeless teeth (planned to be extracted for dento-periodontal causes)
Measured: Day 0 and day 91 post therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startJan 2013
- Primary completionJun 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Localized Aggressive PeriodontitisStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Helmi Hazzaa, Al-Azhar University
- Investigators
- Hala H. Hazzaa, Professor, Principal investigator, Al-Azhar University, Faculty of Dental and Oral Medicine (Girls Branch)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402296
- Sponsor's protocol ID
- Al-Azhar 1-2013
- Status last verified
- May 2015
- First submitted
- 6 Mar 2015
- Last updated
- 9 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
• Prakasam A; Elavarasu SS; Natarajan RK. Antibiotics in the management of aggressive periodontitis. J Pharm Bioallied Sci. 2012; 4 (Suppl 2): S252-5. • Aurer A; Recent Advances in periodontology. Med Sci 2012; 38: 49-59. • Acar NN; Noyan Ü; Kuru L;Kadir T; Kuru B. Adjunctive systemic use of beta-glucan in the nonsurgical treatment of chronic periodontitis. Pathogenesis and treatment of periodontitis 2012; 11: 167-82. • Stashenko P; Wang CY; Riley E; Wu Y; Ostroff G; Niederman R. Reduction of infection-stimulated periapical bone resorption by the biological response modifier PGG Glucan. J Dent Res 1995; 74 (1):323-30. • Chaple CC; Srivastrava M; Hunter N; Failure of macrophage activation in destructive periodontal disease. J Pathol 1988; 186: pp.281-286.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of β-glucan in Treatment of Localized Aggressive Periodontitis: A Short Term Double-blinded, Placebo-controlled, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02402296
- Acronym / sponsor ID
- Al-Azhar 1-2013
- Conditions
- Localized Aggressive Periodontitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Posted 9 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
combining the non-surgical therapy with a well-tolerated substance that can stimulate protective immune responses like B-glucan, might effectively mount resolution pathways contributing to resolving of the chronic lesion observed in aggressive forms of periodontal disease.
Detailed description
Aim: To investigate the efficacy of β-glucan supplementation to non-surgical periodontal therapy in localized aggressive periodontitis (LAP) patients.
Method: 30 subjects were randomly and equally assigned to receive scaling and root planing; either with placebo pills (Group I) or β-glucan (100 mg/once a day) (Group II), for 40 days. Subjects were clinically monitored on day 0 and day 91. Gingival samples were harvested from hopeless teeth sites to be investigated histologically and immunohistochemically using matrix metalloproteinase (MMP)-1 and 9 antibodies form each patient; at the same time intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group II (test group) | Active comparator | Drug: β-1,3/1,6-D-glucanIncluded those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing. |
| Group I (control group) | Placebo comparator | Other: PlaceboWas assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days. |
Who may qualify
- Ages
- 20 to 27 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Except for periodontitis, patients were systemically healthy as evaluated by modified Cornell medical index.
- No more than two teeth other than first molars and incisors, with probing depth (PD) ≥ 5mm, bleeding on probing (BOP), and clinical attachment level (CAL) ≥ 5mm.
- Rapid rate of attachment loss and bone destruction.
- A radiographic examination revealing an evidence of moderate to severe vertical bone loss around permanent incisors and first molar teeth.
- Every patient should have at least 20 teeth excluding third (3rd) molars, and at least an extraction-indicated tooth for a dento-periodontal affection.
Key exclusion criteria (1 listed)
- Previous subgingival scaling and root planing, allergy to β-glucan, smoking, former smoking, pregnancy, need of antibiotic coverage for routine dental therapy, antibiotic therapy in the previous 6 months and allergy to chlorhexidine.
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 |
|---|---|---|
| β-1,3/1,6-D-glucanAlso: Imurril capsules 100mg15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days. | Drug | Group II (test group) |
| PlaceboAlso: Empty capsules filled with carbohydrates15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days. | Other | Group I (control group) |
Primary outcome
Assessment of Change in Clinical Attachment Level (CAL)
Time frame: Day 0 and day 91 post therapy
It is the distance from the base of the pocket till the cemento-enamel junction using Williams graduated probe
3 secondary outcomes
Pocket Depth (PD)
Time frame: Day 0 and day 91 post therapy
Gingival Index (GI)
Time frame: Day 0 and day 91 post therapy
Matrix Metallo-proteinase (MMP-1&9)
Time frame: Day 0 and day 91 post therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background• Prakasam A; Elavarasu SS; Natarajan RK. Antibiotics in the management of aggressive periodontitis. J Pharm Bioallied Sci. 2012; 4 (Suppl 2): S252-5. • Aurer A; Recent Advances in periodontology. Med Sci 2012; 38: 49-59. • Acar NN; Noyan Ü; Kuru L;Kadir T; Kuru B. Adjunctive systemic use of beta-glucan in the nonsurgical treatment of chronic periodontitis. Pathogenesis and treatment of periodontitis 2012; 11: 167-82. • Stashenko P; Wang CY; Riley E; Wu Y; Ostroff G; Niederman R. Reduction of infection-stimulated periapical bone resorption by the biological response modifier PGG Glucan. J Dent Res 1995; 74 (1):323-30. • Chaple CC; Srivastrava M; Hunter N; Failure of macrophage activation in destructive periodontal disease. J Pathol 1988; 186: pp.281-286.
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.
Hala H. Hazzaa, Professor principal investigator
Al-Azhar University, Faculty of Dental and Oral Medicine (Girls Branch)
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing β-1,3/1,6-D-glucan in people with Localized Aggressive Periodontitis, run by Al-Azhar University.
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 6 inclusion and 1 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: finished, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Assessment of Change in Clinical Attachment Level (CAL) (time frame: Day 0 and day 91 post therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02402296, which also lists 1 linked publication.
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 9 Jun 2015.