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OpenTrials
Completed

NCT Number: NCT02402296

Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis

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.

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Key information

Age range

20 year–27 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

β-1,3/1,6-D-glucan

Drug

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.

Other names: Imurril capsules 100mg

Placebo

Other

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.

Other names: Empty capsules filled with carbohydrates

Primary outcomes

  1. 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

Secondary outcomes

  1. Pocket Depth (PD)

    Time frame: Day 0 and day 91 post therapy

    It is the distance from the base of the pocket till the gingival margin using Williams graduated probe

  2. Gingival Index (GI)

    Time frame: Day 0 and day 91 post therapy

    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
  3. Matrix Metallo-proteinase (MMP-1&9)

    Time frame: Day 0 and day 91 post therapy

    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)

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Efficacy of β-glucan in Treatment of Localized Aggressive Periodontitis: A Short Term Double-blinded, Placebo-controlled, Randomized Clinical Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 30, 2015
Registry last updated
Jun 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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