Antibiotic Study for Dental Implants

• Sponsor: OraPharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00662532
• Collaborator: (none)
• Enrollment: 44
• Locations: 4
• Arms: 2
• Duration (Months): 12
• Patients Per Site: 11
• Patients Per Site Per Month: 0.9

Study Details

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
• 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: Apr 1, 2008
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Apr 1, 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 Names: antibiotic
No Intervention: No Intervention Control group receiving no drug intervention

Outcome Measures

Primary Outcome Measures

1. Overall PD Reduction [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 [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 [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

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	JJCPPW Investigational Site	Aurora	Colorado	United States	80012
2	JJCPPW Investigational Site	Ann Arbor	Michigan	United States	48106
3	JJCPPW Investigational Site	Hazlet	New Jersey	United States	07730
4	JJCPPW Investigational Site	Seattle	Washington	United States	98195

Sponsors and Collaborators

• OraPharma

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: OraPharma
• ClinicalTrials.gov Identifier: NCT00662532
• Other Study ID Numbers: OP-P-5265-1
• First Posted: Apr 21, 2008
• Last Update Posted: Dec 12, 2011
• Last Verified: Dec 1, 2011

• Keywords provided by OraPharma: Peri-implantitis; antibiotic
• Additional relevant MeSH terms: Periodontitis; Peri-Implantitis; Anti-Bacterial Agents; Minocycline

Study Results

Participant Flow

Arm/Group Title	Minocycline HCl	No Intervention
Arm/Group Description	1 mg microspheres of minocycline hydrochloride	Control group receiving no drug intervention
Period Title: Overall Study
STARTED	22	22
COMPLETED	22	20
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	Minocycline HCl	No Intervention	Total
Arm/Group Description	1 mg microspheres of minocycline hydrochloride	Control group receiving no drug intervention	Total of all reporting groups
Overall Participants	22	22	44
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.59 (12.37)	66.05 (10.97)	66.82 (11.58)
Sex: Female, Male (Count of Participants)
Female	10 45.5%	11 50%	21 47.7%
Male	12 54.5%	11 50%	23 52.3%
Region of Enrollment (participants) [Number]
United States	22 100%	22 100%	44 100%

Outcome Measures

1. Primary Outcome

Title	Overall PD Reduction
Description	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
Time Frame	Baseline to Day 180

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Minocycline HCl	No Intervention
Arm/Group Description	1 mg microspheres of minocycline hydrochloride	Control group receiving no drug intervention
Measure Participants	22	22
Mean (Standard Deviation) [mm]	1.25 (0.63)	0.66 (0.63)

2. Secondary Outcome

Title	Initial PD Reduction
Description	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
Time Frame	Baseline to Day 90

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Minocycline HCl	No Intervention
Arm/Group Description	1 mg microspheres of minocycline hydrochloride	Control group receiving no drug intervention
Measure Participants	22	22
Mean (Standard Deviation) [mm]	1.02 (0.63)	0.49 (0.58)

3. Secondary Outcome

Title	BOP Percent Reduction From Baseline
Description	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
Time Frame	at Day 90 and Day 180

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Minocycline HCl	No Intervention
Arm/Group Description	1 mg microspheres of minocycline hydrochloride	Control group receiving no drug intervention
Measure Participants	22	22
Day 90	42.17 (38.27) 191.7%	22.53 (31.36) 102.4%
Day 180	60.75 (32.19) 276.1%	32.86 (41.35) 149.4%

Adverse Events

Time Frame	180 Days
Adverse Event Reporting Description	Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%
Arm/Group Title	Minocycline HCl		No Intervention
Arm/Group Description	1 mg microspheres of minocycline hydrochloride		Control group receiving no drug intervention
All Cause Mortality
	Minocycline HCl		No Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Minocycline HCl		No Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/22 (4.5%)		3/22 (13.6%)
Gastrointestinal disorders
Volvulus	1/22 (4.5%)		0/22 (0%)
General disorders
Death	0/22 (0%)		1/22 (4.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant	0/22 (0%)		1/22 (4.5%)
Surgical and medical procedures
Hysterectomy	0/22 (0%)		1/22 (4.5%)
Other (Not Including Serious) Adverse Events
	Minocycline HCl		No Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/22 (27.3%)		4/22 (18.2%)
Ear and labyrinth disorders
Vertigo	0/22 (0%)		1/22 (4.5%)
Gastrointestinal disorders
Gastrooesophageal Reflux Disease	0/22 (0%)		2/22 (9.1%)
General disorders
Nodule	0/22 (0%)		1/22 (4.5%)
Immune system disorders
Seasonal Allergy	1/22 (4.5%)		0/22 (0%)
Infections and infestations
Tooth Abscess	1/22 (4.5%)		1/22 (4.5%)
Ear Infection	1/22 (4.5%)		0/22 (0%)
Infection	0/22 (0%)		1/22 (4.5%)
Onychomycosis	1/22 (4.5%)		0/22 (0%)
Upper Respiratory Tract Infection	0/22 (0%)		1/22 (4.5%)
Injury, poisoning and procedural complications
Bite	1/22 (4.5%)		1/22 (4.5%)
Tooth Fracture	0/22 (0%)		1/22 (4.5%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/22 (4.5%)		0/22 (0%)
Joint Swelling	1/22 (4.5%)		0/22 (0%)
Nervous system disorders
Dizziness	1/22 (4.5%)		0/22 (0%)
Skin and subcutaneous tissue disorders
Lichen Planus	0/22 (0%)		1/22 (4.5%)
Surgical and medical procedures
Endodontic Procedure	1/22 (4.5%)		0/22 (0%)
Tooth Extraction	0/22 (0%)		1/22 (4.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.