Trial Outcomes & Findings for Scaling and Root Planing (SRP) With and Without Minocycline HCl Microspheres, 1 mg (NCT NCT03762915)

NCT ID: NCT03762915

Last Updated: 2025-01-28

Results Overview

This is log 10 of the Bacteria load measured. The lower amount of bacteria means good conditions and the higher amount of bacteria means worse conditions. For data analysis fixed effects terms for log10 pathogen quantity were summarized using estimated marginal means with 95% confidence intervals (CI).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 70 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2025-01-28

Participant Flow

Participant milestones

Measure	SRP With Minocycline HCl Microspheres The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. minocycline HCl microspheres: Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.	SRP Without Minocycline HCl Microspheres The control group will not have minocycline HCl microspheres, 1 mg administered.
Overall Study STARTED	35	35
Overall Study COMPLETED	34	30
Overall Study NOT COMPLETED	1	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race/ethnicity data was not collected for all participants

Baseline characteristics by cohort

Measure	SRP With Minocycline HCl Microspheres n=35 Participants The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. minocycline HCl microspheres: Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.	SRP Without Minocycline HCl Microspheres n=35 Participants The control group will not have minocycline HCl microspheres, 1 mg administered.	Total n=70 Participants Total of all reporting groups
Age, Continuous	51.31 years STANDARD_DEVIATION 16.09 • n=35 Participants	54.29 years STANDARD_DEVIATION 14.78 • n=35 Participants	52.8 years STANDARD_DEVIATION 15.44 • n=70 Participants
Sex: Female, Male Female	12 Participants n=35 Participants	16 Participants n=35 Participants	28 Participants n=70 Participants
Sex: Female, Male Male	23 Participants n=35 Participants	19 Participants n=35 Participants	42 Participants n=70 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=34 Participants • Race/ethnicity data was not collected for all participants	0 Participants n=26 Participants • Race/ethnicity data was not collected for all participants	1 Participants n=60 Participants • Race/ethnicity data was not collected for all participants
Race (NIH/OMB) Asian	4 Participants n=34 Participants • Race/ethnicity data was not collected for all participants	3 Participants n=26 Participants • Race/ethnicity data was not collected for all participants	7 Participants n=60 Participants • Race/ethnicity data was not collected for all participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=34 Participants • Race/ethnicity data was not collected for all participants	0 Participants n=26 Participants • Race/ethnicity data was not collected for all participants	0 Participants n=60 Participants • Race/ethnicity data was not collected for all participants
Race (NIH/OMB) Black or African American	9 Participants n=34 Participants • Race/ethnicity data was not collected for all participants	4 Participants n=26 Participants • Race/ethnicity data was not collected for all participants	13 Participants n=60 Participants • Race/ethnicity data was not collected for all participants
Race (NIH/OMB) White	19 Participants n=34 Participants • Race/ethnicity data was not collected for all participants	16 Participants n=26 Participants • Race/ethnicity data was not collected for all participants	35 Participants n=60 Participants • Race/ethnicity data was not collected for all participants
Race (NIH/OMB) More than one race	0 Participants n=34 Participants • Race/ethnicity data was not collected for all participants	1 Participants n=26 Participants • Race/ethnicity data was not collected for all participants	1 Participants n=60 Participants • Race/ethnicity data was not collected for all participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=34 Participants • Race/ethnicity data was not collected for all participants	2 Participants n=26 Participants • Race/ethnicity data was not collected for all participants	3 Participants n=60 Participants • Race/ethnicity data was not collected for all participants

PRIMARY outcome

Timeframe: Baseline

This is log 10 of the Bacteria load measured. The lower amount of bacteria means good conditions and the higher amount of bacteria means worse conditions.

For data analysis fixed effects terms for log10 pathogen quantity were summarized using estimated marginal means with 95% confidence intervals (CI).

Outcome measures

Measure	SRP With Minocycline HCl Microspheres n=34 Participants The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. minocycline HCl microspheres: Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.	SRP Without Minocycline HCl Microspheres n=30 Participants The control group will not have minocycline HCl microspheres, 1 mg administered.
Bacteria Load (log10)	-11.3 log 10 copies/mL Interval -16.0 to -6.5	-10.9 log 10 copies/mL Interval -16.0 to -5.8

PRIMARY outcome

Timeframe: 3 months

This is log 10 of the Bacteria load measured. The lower amount of bacteria means good conditions and the higher amount of bacteria means worse conditions.

For data analysis fixed effects terms for log10 pathogen quantity were summarized using estimated marginal means with 95% confidence intervals (CI).

Outcome measures

Measure	SRP With Minocycline HCl Microspheres n=34 Participants The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. minocycline HCl microspheres: Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.	SRP Without Minocycline HCl Microspheres n=30 Participants The control group will not have minocycline HCl microspheres, 1 mg administered.
Bacteria Load (log10)	-10.3 log 10 copies/mL Interval -14.8 to -5.9	-10.7 log 10 copies/mL Interval -15.4 to -5.9

PRIMARY outcome

Timeframe: 6 months

This is log 10 of the Bacteria load measured. The lower amount of bacteria means good conditions and the higher amount of bacteria means worse conditions.

For data analysis fixed effects terms for log10 pathogen quantity were summarized using estimated marginal means with 95% confidence intervals (CI).

Outcome measures

Measure	SRP With Minocycline HCl Microspheres n=34 Participants The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. minocycline HCl microspheres: Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.	SRP Without Minocycline HCl Microspheres n=30 Participants The control group will not have minocycline HCl microspheres, 1 mg administered.
Bacteria Load (log10)	-10.3 log 10 copies/mL Interval -15.5 to -5.2	-9.6 log 10 copies/mL Interval -15.0 to -4.1

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 1, 3, and 6 months

Population: The lab had issues with the samples and couldnt use them

mean

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline

mean C-Reactive Protein (CRP)

Outcome measures

Measure	SRP With Minocycline HCl Microspheres n=34 Participants The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. minocycline HCl microspheres: Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.	SRP Without Minocycline HCl Microspheres n=30 Participants The control group will not have minocycline HCl microspheres, 1 mg administered.
Serum Markers	2.34 mg/L Standard Deviation 2.70	1.81 mg/L Standard Deviation 1.59

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

mean CRP

Outcome measures

Measure	SRP With Minocycline HCl Microspheres n=34 Participants The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. minocycline HCl microspheres: Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.	SRP Without Minocycline HCl Microspheres n=30 Participants The control group will not have minocycline HCl microspheres, 1 mg administered.
Serum Markers	1.87 mg/L Standard Deviation 2.66	2.09 mg/L Standard Deviation 2.36

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

mean CRP

Outcome measures

Measure	SRP With Minocycline HCl Microspheres n=34 Participants The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. minocycline HCl microspheres: Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.	SRP Without Minocycline HCl Microspheres n=30 Participants The control group will not have minocycline HCl microspheres, 1 mg administered.
Serum Markers	1.87 mg/L Standard Deviation 2.05	1.89 mg/L Standard Deviation 2.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

mean CRP

Outcome measures

Measure	SRP With Minocycline HCl Microspheres n=34 Participants The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. minocycline HCl microspheres: Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.	SRP Without Minocycline HCl Microspheres n=30 Participants The control group will not have minocycline HCl microspheres, 1 mg administered.
Serum Markers	1.79 mg/L Standard Deviation 2.18	1.60 mg/L Standard Deviation 2.10

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline

Outcome measures

Measure	SRP With Minocycline HCl Microspheres n=34 Participants The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. minocycline HCl microspheres: Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.	SRP Without Minocycline HCl Microspheres n=30 Participants The control group will not have minocycline HCl microspheres, 1 mg administered.
Glycated Hemoglobin (HbA1c)	5.53 percentage Standard Deviation 0.48	5.62 percentage Standard Deviation 0.98

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

Outcome measures

Measure	SRP With Minocycline HCl Microspheres n=34 Participants The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. minocycline HCl microspheres: Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.	SRP Without Minocycline HCl Microspheres n=30 Participants The control group will not have minocycline HCl microspheres, 1 mg administered.
HbA1c	5.62 percentage Standard Deviation 0.40	5.64 percentage Standard Deviation 0.93

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Outcome measures

Measure	SRP With Minocycline HCl Microspheres n=34 Participants The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. minocycline HCl microspheres: Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.	SRP Without Minocycline HCl Microspheres n=30 Participants The control group will not have minocycline HCl microspheres, 1 mg administered.
HbA1c	5.59 percentage Standard Deviation 0.43	5.65 percentage Standard Deviation 0.85

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Outcome measures

Measure	SRP With Minocycline HCl Microspheres n=34 Participants The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. minocycline HCl microspheres: Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.	SRP Without Minocycline HCl Microspheres n=30 Participants The control group will not have minocycline HCl microspheres, 1 mg administered.
HbA1c	5.56 percentage Standard Deviation 0.40	5.54 percentage Standard Deviation 0.48

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline

Outcome measures

Measure	SRP With Minocycline HCl Microspheres n=34 Participants The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. minocycline HCl microspheres: Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.	SRP Without Minocycline HCl Microspheres n=30 Participants The control group will not have minocycline HCl microspheres, 1 mg administered.
Mean Haptoglobin (Hp)	115 mg/dL Standard Deviation 41	115 mg/dL Standard Deviation 48

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

Outcome measures

Measure	SRP With Minocycline HCl Microspheres n=34 Participants The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. minocycline HCl microspheres: Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.	SRP Without Minocycline HCl Microspheres n=30 Participants The control group will not have minocycline HCl microspheres, 1 mg administered.
Mean Hp	108 mg/dL Standard Deviation 35	110 mg/dL Standard Deviation 39

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Outcome measures

Measure	SRP With Minocycline HCl Microspheres n=34 Participants The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. minocycline HCl microspheres: Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.	SRP Without Minocycline HCl Microspheres n=30 Participants The control group will not have minocycline HCl microspheres, 1 mg administered.
Mean Hp	110 mg/dL Standard Deviation 36	114 mg/dL Standard Deviation 38

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Outcome measures

Measure	SRP With Minocycline HCl Microspheres n=34 Participants The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. minocycline HCl microspheres: Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.	SRP Without Minocycline HCl Microspheres n=30 Participants The control group will not have minocycline HCl microspheres, 1 mg administered.
Mean Hp	115 mg/dL Standard Deviation 40	110 mg/dL Standard Deviation 38

Adverse Events

SRP With Minocycline HCl Microspheres

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SRP Without Minocycline HCl Microspheres

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michelle Arnette

University of Minnesota

Phone: 6126243457

Email: marnett@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place