Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis

Localized Aggressive Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02402296
• Other study ID #: Al-Azhar 1-2013
• Status: Completed
• Phase: Phase 4
• First received: March 6, 2015
• Last updated: May 21, 2015
• Start date: January 2013
• Est. completion date: August 2014

Study information

• Verified date: May 2015
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 27 Years

Eligibility

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 ß-glucan, smoking, former smoking, pregnancy, need of antibiotic coverage for routine dental therapy, antibiotic therapy in the previous 6 months and allergy to chlorhexidine.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aggression
• Aggressive Periodontitis
• Localized Aggressive Periodontitis
• Periodontitis

Intervention

Drug:
• ß-1,3/1,6-D-glucan
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 ß-1,3/1,6-D-glucan oral supplementation for 40 days.

Other:
• Placebo
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

References & Publications (1)

• 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 0 and day 91 post therapy	No
Secondary	Pocket Depth (PD)	It is the distance from the base of the pocket till the gingival margin using Williams graduated probe	Day 0 and day 91 post therapy	No
Secondary	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	Day 0 and day 91 post therapy	No
Secondary	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)	Day 0 and day 91 post therapy	No