Antibiotic Study for Dental Implants

• ClinicalTrials.gov Identifier: NCT00662532
• Recruitment Status: Completed
• First Posted: April 21, 2008
• Results First Posted: May 27, 2010
• Last Update Posted: December 12, 2011
• Sponsor: OraPharma
• Information provided by (Responsible Party): OraPharma

Study Description

Brief Summary:

This study is for people at least 21 years old who have signs of problems, like swollen gums and shrinking bones, by dental implants.

Condition or disease	Intervention/treatment	Phase
Periodontitis	Drug: Minocycline HCl	Phase 3

Detailed Description:

At Visit 1, the dentist will:

• do an oral exam
• ask some questions
• decide if the person qualifies for being in the study
• make an appointment for Visit 2 if they qualify

At Visit 2 (Baseline), the dentist will:

• do a special cleaning of the implants
• examine the whole mouth
• collect some fluid
• take x-rays

• put the people into one of two groups (taking into account whether or not they smoke)

  1. one group will have the study antibiotic put on all the areas in their mouth with gum problems
  2. the other group will not receive the antibiotic At Visit 3 (about a month later), only fluid samples will be collected.

At Visit 4 (about 3 months later), the dentist will:

• collect fluid samples
• examine the whole mouth
• apply the antibiotic again for people in that group

At Visit 5 (about 6 months later), the dentist will:

• collect fluid samples
• examine the whole mouth
• take x-rays

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects With Peri-Implantitis
• Study Start Date: April 2008
• Actual Primary Completion Date: April 2009
• Actual Study Completion Date: April 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Minocycline HCl; 1 mg microspheres of minocycline hydrochloride	Drug: Minocycline HCl; 1mg microspheres for professional subgingival administration into periodontal pockets two times throughout the duration of the trial; Other Name: antibiotic
No Intervention: No Intervention; Control group receiving no drug intervention

Outcome Measures

Primary Outcome Measures :

1. Overall PD Reduction [ Time Frame: Baseline to Day 180 ]
   Mean reduction of probing depth (PD) of qualified implant sites is derived by calculating the change of PD per qualified implant site (PD at baseline minus PD at post-baseline), and then averaging the site-specific PD changes per subject

Secondary Outcome Measures :

1. Initial PD Reduction [ Time Frame: Baseline to Day 90 ]
   Mean reduction of probing depth (PD) of qualified implant sites is derived by calculating the change of PD per qualified implant site (PD at baseline minus PD at post-baseline), and then averaging the site-specific PD changes per subject
2. BOP Percent Reduction From Baseline [ Time Frame: at Day 90 and Day 180 ]
   Bleeding on Probing (BOP) percentage is calculated as the number of implant sites with bleeding divided by the number of implant sites per subject times 100% at each visit; reduction of BOP percentage is the BOP percentage at baseline minus the BOP percentage post-baseline

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 21 years of age and good general health
• appropriately documented Informed Consent
• willing to adhere to the study schedule, prohibitions and restrictions specified in the protocol
• female subjects must meet the pregnancy and contraceptive requirements
• must have oral health appropriate for study inclusion

Exclusion Criteria:

• oral health inappropriate for study inclusion
• females self-reporting pregnancy or lactation, or having a positive urine pregnancy result
• reporting any of the following conditions:
• allergy to a tetracycline-class drug
• systemic medical conditions requiring antibiotic prophylaxis prior to invasive dental procedures
• active systemic infectious disease such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis
• diagnosed with clinically significant or unstable organic disease, or compromised healing potential, heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement
• participation in a dental clinical trial or use of an investigational drug within 30 days of enrollment
• employees of the Investigator or study center, with direct involvement in the proposed study or other studies, as well as family members of the employees or the Investigator
• anyone who the investigator determines should not be included in the study for any reason that could compromise safety or the analysis of study results

Contacts and Locations

Locations

United States, Colorado

JJCPPW Investigational Site

Aurora, Colorado, United States, 80012

United States, Michigan

JJCPPW Investigational Site

Ann Arbor, Michigan, United States, 48106

United States, New Jersey

JJCPPW Investigational Site

Hazlet, New Jersey, United States, 07730

United States, Washington

JJCPPW Investigational Site

Seattle, Washington, United States, 98195

Sponsors and Collaborators

OraPharma

Investigators

• Study Director: Michael Lynch, DMD, PhD; OraPharma

More Information

• Responsible Party: OraPharma
• ClinicalTrials.gov Identifier: NCT00662532
• Other Study ID Numbers: OP-P-5265-1
• First Posted: April 21, 2008
• Results First Posted: May 27, 2010
• Last Update Posted: December 12, 2011
• Last Verified: December 2011

Keywords provided by OraPharma:

Peri-implantitis; antibiotic

Additional relevant MeSH terms:

Periodontitis; Peri-Implantitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Anti-Bacterial Agents; Minocycline; Anti-Infective Agents