Trial Outcomes & Findings for Antibiotic Study for Dental Implants (NCT NCT00662532)

Last Updated: 2011-12-12

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

44 participants

Primary outcome timeframe

Baseline to Day 180

Results posted on

2011-12-12

Participant Flow

Participant milestones

Participant milestones
Measure	Minocycline HCl 1 mg microspheres of minocycline hydrochloride	No Intervention Control group receiving no drug intervention
Overall Study STARTED	22	22
Overall Study COMPLETED	22	20
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Minocycline HCl 1 mg microspheres of minocycline hydrochloride	No Intervention Control group receiving no drug intervention
Overall Study Adverse Event	0	1
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Antibiotic Study for Dental Implants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Minocycline HCl n=22 Participants 1 mg microspheres of minocycline hydrochloride	No Intervention n=22 Participants Control group receiving no drug intervention	Total n=44 Participants Total of all reporting groups
Age Continuous	67.59 years STANDARD_DEVIATION 12.37 • n=5 Participants	66.05 years STANDARD_DEVIATION 10.97 • n=7 Participants	66.82 years STANDARD_DEVIATION 11.58 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	22 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Day 180

Outcome measures

Outcome measures
Measure	Minocycline HCl n=22 Participants 1 mg microspheres of minocycline hydrochloride	No Intervention n=22 Participants Control group receiving no drug intervention
Overall PD Reduction	1.25 mm Standard Deviation 0.63	0.66 mm Standard Deviation 0.63

SECONDARY outcome

Timeframe: Baseline to Day 90

Outcome measures

Outcome measures
Measure	Minocycline HCl n=22 Participants 1 mg microspheres of minocycline hydrochloride	No Intervention n=22 Participants Control group receiving no drug intervention
Initial PD Reduction	1.02 mm Standard Deviation 0.63	0.49 mm Standard Deviation 0.58

SECONDARY outcome

Timeframe: at Day 90 and Day 180

Population: ITT

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

Outcome measures

Outcome measures
Measure	Minocycline HCl n=22 Participants 1 mg microspheres of minocycline hydrochloride	No Intervention n=22 Participants Control group receiving no drug intervention
BOP Percent Reduction From Baseline Day 180	60.75 Percentage of Participants Standard Deviation 32.19	32.86 Percentage of Participants Standard Deviation 41.35
BOP Percent Reduction From Baseline Day 90	42.17 Percentage of Participants Standard Deviation 38.27	22.53 Percentage of Participants Standard Deviation 31.36

Adverse Events

Minocycline HCl

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

No Intervention

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Minocycline HCl n=22 participants at risk 1 mg microspheres of minocycline hydrochloride	No Intervention n=22 participants at risk Control group receiving no drug intervention
Gastrointestinal disorders Volvulus	4.5% 1/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%	0.00% 0/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%
General disorders Death	0.00% 0/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%	4.5% 1/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	0.00% 0/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%	4.5% 1/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%
Surgical and medical procedures Hysterectomy	0.00% 0/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%	4.5% 1/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%

Other adverse events

Additional Information

Ms. Bindu Patel, Senior Scientist, Regulatory Affairs and Quality Assurance

OraPharma

Phone: 215-420-4064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Minocycline HCl n=22 participants at risk 1 mg microspheres of minocycline hydrochloride	No Intervention n=22 participants at risk Control group receiving no drug intervention
Infections and infestations Tooth Abscess	4.5% 1/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%	4.5% 1/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%
Infections and infestations Ear Infection	4.5% 1/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%	0.00% 0/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%
Infections and infestations Infection	0.00% 0/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%	4.5% 1/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%
Infections and infestations Onychomycosis	4.5% 1/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%	0.00% 0/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%	4.5% 1/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%	9.1% 2/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%
Injury, poisoning and procedural complications Bite	4.5% 1/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%	4.5% 1/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%
Injury, poisoning and procedural complications Tooth Fracture	0.00% 0/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%	4.5% 1/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%
Surgical and medical procedures Endodontic Procedure	4.5% 1/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%	0.00% 0/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%
Surgical and medical procedures Tooth Extraction	0.00% 0/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%	4.5% 1/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%
General disorders Nodule	0.00% 0/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%	4.5% 1/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%
Ear and labyrinth disorders Vertigo	0.00% 0/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%	4.5% 1/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%
Immune system disorders Seasonal Allergy	4.5% 1/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%	0.00% 0/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%
Musculoskeletal and connective tissue disorders Arthralgia	4.5% 1/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%	0.00% 0/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%
Musculoskeletal and connective tissue disorders Joint Swelling	4.5% 1/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%	0.00% 0/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%
Nervous system disorders Dizziness	4.5% 1/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%	0.00% 0/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%
Skin and subcutaneous tissue disorders Lichen Planus	0.00% 0/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%	4.5% 1/22 • 180 Days Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%