Clinical Trial: Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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.


Sponsor: Al-Azhar University

Current 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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

    1. delayed bleeding on probing
    2. immediate bleeding on probing
    3. spontaneous bleeding
  • 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)


Original Secondary Outcome:

  • 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
  • Gingival Index (GI) [ Time Frame: Day 0 and day 91 post therapy ]
    Using the values of the gingival index according to (Loe & Silness, 1963)
  • 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)


Information By: Al-Azhar University

Dates:
Date Received: March 6, 2015
Date Started: January 2013
Date Completion:
Last Updated: May 21, 2015
Last Verified: May 2015