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

O

OraPharma

Status and phase

Completed
Phase 3

Conditions

Periodontitis

Treatments

Drug: Minocycline HCL Microspheres

Study type

Interventional

Funder types

Industry

Identifiers

NCT00371332
OPI-145'

Details and patient eligibility

About

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

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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