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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00371332
Enrollment
128
Registered
2006-09-04
Start date
2004-01-31
Completion date
Unknown
Last updated
2006-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

Keywords

chronic periodontitis, mouth, Moderate to advanced chronic periodontitis

Brief summary

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

Interventions

Sponsors

OraPharma
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years

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

Design outcomes

Primary

MeasureTime frame
The change in the mean sum of primary pathogens (P. gingivalis, To forsythensis, and T. denticola) from baseline to 30 days.

Secondary

MeasureTime frame
Changes in the numbers of each of the primary pathogens, changes in pocket depth, attachment level, and proportion of sites bleeding on probing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026