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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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

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 groups in NCT02402296
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
1. delayed bleeding on probing
2. immediate bleeding on probing
3. 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.

Jan 2013Aug 2014

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)

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.

Detailed description

Aim: To investigate the efficacy of β-glucan supplementation to non-surgical periodontal therapy in localized aggressive periodontitis (LAP) patients.

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

Results posted to the registry on 9 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group I (Control Group)	15	15
Group II (Test Group)	15	15

Primary outcome: Assessment of Change in Clinical Attachment Level (CAL)

Time frame: Day 0 and day 91 post therapy. Mean (Standard Deviation). Unit: percentage of change

Measure	Group I (Control Group) n = 15	Group II (Test Group) n = 15
Value	-14.07 (12.29)	-37.48 (17.69)

Population analysed: A total of 30 localized aggressive periodontitis (LAP) participants were included in this study. Medical and dental histories were obtained and intraoral examinations were carried out at pre-screening visit. Patients were diagnosed to have LAP based on the clinical and radiographic findings measurements

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group I (Control Group)	0 of 15 (0%)	0 of 15 (0%)	Not reported
Group II (Test Group)	0 of 15 (0%)	0 of 15 (0%)	Not reported

Limitations and caveats (from the sponsor): No limitations or caveats were reported throughout the study period.

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.