Effect of Adjunctive Treatment With Arestin on the Subgingival Microflora in Patients With Moderate to Advanced Periodontitis

Periodontitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00371332
• Other study ID #: OPI-145`
• Status: Completed
• Phase: Phase 3
• First received: September 1, 2006
• Last updated: September 22, 2006
• Start date: January 2004

Study information

• Verified date: September 2006
• Source: OraPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to measure the antimicrobial effects of Arestin in subjects with moderate to advanced periodontal disease

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Generalized moderate to advanced chronic periodontitis, five sites with probing depths of >5 mm in 5 non-adjacent interproximal spaces, excluding the distal of terminal teeth, at least 16 teeth excluding 3rd molars and implants

Exclusion Criteria:

• Allergy to tetracycline

• Subjects with aggressive periodontitis

• Acute necrotizing ulcerative gingivitis, or gross decay

• Systemic conditions which could influence the course of periodontal disease (i.e, diabetes, autoimmune disease, etc)

• Individuals requiring prophylactic antibiotics

• Any periodontal therapy within the previous 3 months (excluding maintenance therapy)

• Systemic or local antibiotic therapy within three months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periodontitis

Intervention

Drug:
• Minocycline HCL Microspheres

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
OraPharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in the mean sum of primary pathogens (P. gingivalis, To forsythensis, and T. denticola) from baseline to 30 days.
Secondary	Changes in the numbers of each of the primary pathogens, changes in pocket depth, attachment level, and proportion of sites bleeding on probing