Periocline as an Adjunct to Scaling and Root Planing for Adult Periodontitis

NCT00529555 | Completed Phase 3 Results

• 1 other identifier: SB-PER-05-001
• Study Type: interventional
• Target: 602
• Locations: 1 country
• Sites: 10

Brief Summary

Periodontal disease (commonly called gum disease) is generally treated by deep cleaning of the root surfaces of the teeth. This is also called scaling and root planing. Placing a topical antibiotic into the periodontal pocket at the time of scaling and root planing may help reduce pocket depth and thus help the periodontal disease. Periocline (minocycline HCl) 2.1% gel is a topical antibiotic approved in a number of countries for this use, and is now being tested in the US.

Conditions

Adult Periodontitis

Outcome Measures

Primary Outcomes (1)

• Change in Pocket Depth.

  Average change of Pocket Depth at 9 months from baseline

  baseline & 9 months

Study Arms (3)

Scaling and root planing + SHAM TX

SHAM COMPARATOR

sham treatment

Procedure: Scaling and root planing

Scaling and root planing + Vehicle

PLACEBO COMPARATOR

Placebo

Procedure: Scaling and root planing

Scaling & root planing + Periocline Gel

ACTIVE COMPARATOR

Minocycline HCL 2.1%

Drug: minocycline HCl 2.1%

Interventions

minocycline HCl 2.1% DRUG

Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months.

Also known as: periocline

Scaling & root planing + Periocline Gel

Scaling and root planing PROCEDURE

scaling and root planing

Also known as: SRP

Scaling and root planing + SHAM TX; Scaling and root planing + Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• moderate to severe periodontitis

You may not qualify if:

• recent periodontal therapy
• certain medical or dental conditions
• pregnancy
• allergy to active drug or related drugs

Sponsors & Collaborators

• Sunstar Americas: lead

Study Sites (10)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California - San Francisco

San Francisco, California, 94143, United States

Location

University of Florida

Gainsville, Florida, 32610, United States

Location

University of Maryland - Dental School

Baltimore, Maryland, 21201, United States

Location

Boston University Dental School

Boston, Massachusetts, 02118, United States

Location

University of Michigan Oral Health Research Center

Ann Arbor, Michigan, 48106, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

State University of New York at Buffalo, Dental Medicine

Buffalo, New York, 14214, United States

Location

University of Pennsylvania Dental School

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Results Point of Contact

• Title: Marie Wilson, Clinical Program Manager
• Organization: Sunstar Americas, Inc

marie.wilson@us.sunstar.com

773-481-3327

Study Officials

• Robert Genco, DDS, PhD

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2007
• First Posted: September 14, 2007
• Study Start: January 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 9, 2014
• Results First Posted: May 9, 2014

Record last verified: 2014-04

Locations

US (10)