Trial Outcomes & Findings for Local and Systemic Antimicrobials in Non-surgical Periodontal Therapy (NCT NCT05608564)
NCT ID: NCT05608564
Last Updated: 2025-07-17
Results Overview
Pocket probing depth (PPD) was measured using a periodontal probe at 6 sites per tooth, recorded in millimeters (mm), at baseline and at 6-month follow-up. This measure was used to compare outcomes between local and systemic antimicrobial therapies.
COMPLETED
NA
38 participants
baseline and 6 months follow up
2025-07-17
Participant Flow
Of the 38 participants screened at the Department of Periodontology and Oral Medicine at the School of Dental Medicine University of Belgrade, 38 participants were enrolled
All 38 participants who met the inclusion criteria were enrolled and directly assigned to study groups without a pre-assignment phase.
Participant milestones
| Measure |
Open- Label Local Antibiotic Group
A combination of Piperacillin and Tazobactam in gel form is applied using a syringe and a flexible blunt needle into the periodontal pockets 24 hours after the non-surgical periodontal therapy. After administration, the dry field should be maintained for 5 minutes and the patient should not rinse the oral cavity for 15 minutes.
Piperacillin and Tazobactam in gel form: After non-surgical periodontal treatment, the test group will receive local antibiotics.
|
Open- Label Systemic Antibotic Group
Amoxicillin (500mg, 3 times a day, 7 days) and Metronidazole (400mg, 3 times a day, 7 days) per os at the beginning of non-surgical treatment.
Amoxicillin and Metronidazole: After non-surgical periodontal treatment, the control group will receive systemic antibiotics.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Local Antibiotic Group
n=19 Participants
A combination of Piperacillin and Tazobactam in gel form is applied using a syringe and a flexible blunt needle into the periodontal pockets 24 hours after the non-surgical periodontal therapy. After administration, the dry field should be maintained for 5 minutes and the patient should not rinse the oral cavity for 15 minutes.
Piperacillin and Tazobactam in gel form: After non-surgical periodontal treatment, the test group will receive local antibiotics.
|
Systemic Antibotic Group
n=19 Participants
Amoxicillin (500mg, 3 times a day, 7 days) and Metronidazole (400mg, 3 times a day, 7 days) per os at the beginning of non-surgical treatment.
Amoxicillin and Metronidazole: After non-surgical periodontal treatment, the control group will receive systemic antibiotics.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.59 years
n=19 Participants
|
36.06 years
n=19 Participants
|
34.83 years
n=38 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=19 Participants
|
12 Participants
n=19 Participants
|
23 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=19 Participants
|
7 Participants
n=19 Participants
|
15 Participants
n=38 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Serbia
|
19 participants
n=19 Participants
|
19 participants
n=19 Participants
|
38 participants
n=38 Participants
|
|
PPD baseline
|
3.932 mm
STANDARD_DEVIATION 0.5355 • n=19 Participants
|
4.082 mm
STANDARD_DEVIATION 0.5812 • n=19 Participants
|
4.007 mm
STANDARD_DEVIATION 0.556 • n=38 Participants
|
|
CAL baseline
|
4.4 mm
STANDARD_DEVIATION 0.8452 • n=19 Participants
|
4.494 mm
STANDARD_DEVIATION 0.7677 • n=19 Participants
|
4.447 mm
STANDARD_DEVIATION 0.8088 • n=38 Participants
|
|
BOP baseline
|
0.6311 percentage
STANDARD_DEVIATION 0.1214 • n=19 Participants
|
0.6794 percentage
STANDARD_DEVIATION 0.1861 • n=19 Participants
|
0.655 percentage
STANDARD_DEVIATION 0.157 • n=38 Participants
|
|
PI baseline
|
0.6537 percentage
STANDARD_DEVIATION 0.1283 • n=19 Participants
|
0.7041 percentage
STANDARD_DEVIATION 0.2525 • n=19 Participants
|
0.670 percentage
STANDARD_DEVIATION 0.119 • n=38 Participants
|
|
TBL
|
1.87 CFU/mL
STANDARD_DEVIATION 5.44 • n=19 Participants
|
1.79 CFU/mL
STANDARD_DEVIATION 5.54 • n=19 Participants
|
1.80 CFU/mL
STANDARD_DEVIATION 5.42 • n=38 Participants
|
|
TNF-α
|
0.03347 ng/mL
STANDARD_DEVIATION 0.01475 • n=19 Participants
|
0.05048 ng/mL
STANDARD_DEVIATION 0.06895 • n=19 Participants
|
0.042 ng/mL
STANDARD_DEVIATION 0.050 • n=38 Participants
|
|
IL-17
|
0.008072 ng/mL
STANDARD_DEVIATION 0.004611 • n=19 Participants
|
0.007164 ng/mL
STANDARD_DEVIATION 0.008121 • n=19 Participants
|
0.00762 ng/mL
STANDARD_DEVIATION 0.00653 • n=38 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 months follow upPopulation: All patients from both groups, at baseline and 6 months recall.
Pocket probing depth (PPD) was measured using a periodontal probe at 6 sites per tooth, recorded in millimeters (mm), at baseline and at 6-month follow-up. This measure was used to compare outcomes between local and systemic antimicrobial therapies.
Outcome measures
| Measure |
Open- Label Local Antibiotic Group
n=19 Participants
A combination of Piperacillin and Tazobactam in gel form is applied using a syringe and a flexible blunt needle into the periodontal pockets 24 hours after the non-surgical periodontal therapy. After administration, the dry field should be maintained for 5 minutes and the patient should not rinse the oral cavity for 15 minutes.
Piperacillin and Tazobactam in gel form: After non-surgical periodontal treatment, the test group will receive local antibiotics.
|
Open- Label Systemic Antibotic Group
n=19 Participants
Amoxicillin (500mg, 3 times a day, 7 days) and Metronidazole (400mg, 3 times a day, 7 days) per os at the beginning of non-surgical treatment.
Amoxicillin and Metronidazole: After non-surgical periodontal treatment, the control group will receive systemic antibiotics.
|
|---|---|---|
|
Change in Pocket Probing Depth (PPD)
PPD baseline
|
3.932 mm
Standard Deviation 0.5355
|
4.082 mm
Standard Deviation 0.5812
|
|
Change in Pocket Probing Depth (PPD)
PPD 6 months
|
3.253 mm
Standard Deviation 0.5048
|
3.294 mm
Standard Deviation 0.5471
|
PRIMARY outcome
Timeframe: baseline and 6 months follow upPopulation: All patients from both groups, at baseline and 6 months recall.
Pocket probing depth (PPD) was measured using a periodontal probe at 6 sites per tooth, recorded in millimeters (mm), at baseline and at 6-month follow-up. This measure was used to compare outcomes between local and systemic antimicrobial therapies.
Outcome measures
| Measure |
Open- Label Local Antibiotic Group
n=19 Participants
A combination of Piperacillin and Tazobactam in gel form is applied using a syringe and a flexible blunt needle into the periodontal pockets 24 hours after the non-surgical periodontal therapy. After administration, the dry field should be maintained for 5 minutes and the patient should not rinse the oral cavity for 15 minutes.
Piperacillin and Tazobactam in gel form: After non-surgical periodontal treatment, the test group will receive local antibiotics.
|
Open- Label Systemic Antibotic Group
n=19 Participants
Amoxicillin (500mg, 3 times a day, 7 days) and Metronidazole (400mg, 3 times a day, 7 days) per os at the beginning of non-surgical treatment.
Amoxicillin and Metronidazole: After non-surgical periodontal treatment, the control group will receive systemic antibiotics.
|
|---|---|---|
|
Change in Clinical Attachment Level (CAL)
CAL baseline
|
4.4 mm
Standard Deviation 0.8452
|
4.494 mm
Standard Deviation 0.7677
|
|
Change in Clinical Attachment Level (CAL)
CAL 6 months
|
3.832 mm
Standard Deviation 0.9062
|
4.035 mm
Standard Deviation 0.8031
|
PRIMARY outcome
Timeframe: baseline and 6 months follow upPopulation: All patients from both groups, at baseline and 6 months recall.
Bleeding on probing (BOP) was assessed using a periodontal probe at 6 sites around each present tooth during baseline and 6-month follow-up clinical examinations. BOP was recorded as present (1) or absent (0) at each site, and expressed as a percentage (%).
Outcome measures
| Measure |
Open- Label Local Antibiotic Group
n=19 Participants
A combination of Piperacillin and Tazobactam in gel form is applied using a syringe and a flexible blunt needle into the periodontal pockets 24 hours after the non-surgical periodontal therapy. After administration, the dry field should be maintained for 5 minutes and the patient should not rinse the oral cavity for 15 minutes.
Piperacillin and Tazobactam in gel form: After non-surgical periodontal treatment, the test group will receive local antibiotics.
|
Open- Label Systemic Antibotic Group
n=19 Participants
Amoxicillin (500mg, 3 times a day, 7 days) and Metronidazole (400mg, 3 times a day, 7 days) per os at the beginning of non-surgical treatment.
Amoxicillin and Metronidazole: After non-surgical periodontal treatment, the control group will receive systemic antibiotics.
|
|---|---|---|
|
Change in Bleeding On Probing (BOP)
BOP baseline
|
0.6311 percentage
Standard Deviation 0.1214
|
0.6794 percentage
Standard Deviation 0.1861
|
|
Change in Bleeding On Probing (BOP)
BOP 6 months
|
0.1232 percentage
Standard Deviation 0.0844
|
0.6794 percentage
Standard Deviation 0.1861
|
PRIMARY outcome
Timeframe: baseline and 6 months follow upPopulation: All patients from both groups, at baseline and 6 months recall.
Plaque Index (PI) was assessed using a periodontal probe at 6 sites around each present tooth during baseline and 6-month follow-up clinical examinations. BOP was recorded as present (1) or absent (0) at each site, and expressed as a percentage (%).
Outcome measures
| Measure |
Open- Label Local Antibiotic Group
n=19 Participants
A combination of Piperacillin and Tazobactam in gel form is applied using a syringe and a flexible blunt needle into the periodontal pockets 24 hours after the non-surgical periodontal therapy. After administration, the dry field should be maintained for 5 minutes and the patient should not rinse the oral cavity for 15 minutes.
Piperacillin and Tazobactam in gel form: After non-surgical periodontal treatment, the test group will receive local antibiotics.
|
Open- Label Systemic Antibotic Group
n=19 Participants
Amoxicillin (500mg, 3 times a day, 7 days) and Metronidazole (400mg, 3 times a day, 7 days) per os at the beginning of non-surgical treatment.
Amoxicillin and Metronidazole: After non-surgical periodontal treatment, the control group will receive systemic antibiotics.
|
|---|---|---|
|
Change in Plaque Index (PI)
PI baseline
|
0.6537 percentage
Standard Deviation 0.1283
|
0.7041 percentage
Standard Deviation 0.2525
|
|
Change in Plaque Index (PI)
PI 6 months
|
0.1005 percentage
Standard Deviation 0.06399
|
0.1147 percentage
Standard Deviation 0.04048
|
SECONDARY outcome
Timeframe: baseline and 6 months follow upPopulation: All patients from both groups, at baseline and 6 months recall.
Relative expression levels (REL) of TNF-α were assessed in gingival crevicular fluid (GCF) samples collected from periodontal pockets at baseline and 6-month follow-up. GCF was obtained using sterile paper strips, and TNF-α levels were quantified using the real-time polymerase chain reaction (qPCR) method. Results were expressed in nanograms per milliliter (ng/mL) to compare local and systemic antimicrobial therapy groups.
Outcome measures
| Measure |
Open- Label Local Antibiotic Group
n=19 Participants
A combination of Piperacillin and Tazobactam in gel form is applied using a syringe and a flexible blunt needle into the periodontal pockets 24 hours after the non-surgical periodontal therapy. After administration, the dry field should be maintained for 5 minutes and the patient should not rinse the oral cavity for 15 minutes.
Piperacillin and Tazobactam in gel form: After non-surgical periodontal treatment, the test group will receive local antibiotics.
|
Open- Label Systemic Antibotic Group
n=19 Participants
Amoxicillin (500mg, 3 times a day, 7 days) and Metronidazole (400mg, 3 times a day, 7 days) per os at the beginning of non-surgical treatment.
Amoxicillin and Metronidazole: After non-surgical periodontal treatment, the control group will receive systemic antibiotics.
|
|---|---|---|
|
Changes in Relative Expression Levels of Tumor Necrois Factor Alpha (TNF-α)
TNF-α baseline
|
0.03347 ng/mL
Standard Deviation 0.01475
|
0.05048 ng/mL
Standard Deviation 0.06895
|
|
Changes in Relative Expression Levels of Tumor Necrois Factor Alpha (TNF-α)
TNF-α 6 months
|
0.03483 ng/mL
Standard Deviation 0.03704
|
0.02407 ng/mL
Standard Deviation 0.01503
|
SECONDARY outcome
Timeframe: baseline and 6 months follow upPopulation: All patients from both groups, at baseline and 6 months recall.
Total bacterial load (TBL) was assessed in gingival crevicular fluid (GCF) samples collected from periodontal pockets at baseline and at the 6-month follow-up. GCF was obtained using sterile paper strips, and bacterial quantification was performed using the real-time polymerase chain reaction (qPCR) method. Results were expressed in colony-forming units per milliliter (CFU/mL) to evaluate differences between local and systemic antimicrobial therapies.
Outcome measures
| Measure |
Open- Label Local Antibiotic Group
n=19 Participants
A combination of Piperacillin and Tazobactam in gel form is applied using a syringe and a flexible blunt needle into the periodontal pockets 24 hours after the non-surgical periodontal therapy. After administration, the dry field should be maintained for 5 minutes and the patient should not rinse the oral cavity for 15 minutes.
Piperacillin and Tazobactam in gel form: After non-surgical periodontal treatment, the test group will receive local antibiotics.
|
Open- Label Systemic Antibotic Group
n=19 Participants
Amoxicillin (500mg, 3 times a day, 7 days) and Metronidazole (400mg, 3 times a day, 7 days) per os at the beginning of non-surgical treatment.
Amoxicillin and Metronidazole: After non-surgical periodontal treatment, the control group will receive systemic antibiotics.
|
|---|---|---|
|
Change in Total Bacterial Load (TBL)
TBL baseline
|
1.87 CFU/mL
Standard Deviation 5.44
|
1.79 CFU/mL
Standard Deviation 5.54
|
|
Change in Total Bacterial Load (TBL)
TBL 6 months
|
1.71 CFU/mL
Standard Deviation 4.27
|
2.00 CFU/mL
Standard Deviation 4.61
|
SECONDARY outcome
Timeframe: baseline and 6 months follow upPopulation: All patients from both groups, at baseline and 6 months recall.
Relative expression levels (REL) of interleukin-17 (IL-17) were assessed in gingival crevicular fluid (GCF) samples collected from periodontal pockets at baseline and at the 6-month follow-up. GCF was obtained using sterile paper strips, and REL of IL-17 was quantified using the real-time polymerase chain reaction (qPCR) method. Results were expressed in nanograms per milliliter (ng/mL) to compare local and systemic antimicrobial therapies.
Outcome measures
| Measure |
Open- Label Local Antibiotic Group
n=19 Participants
A combination of Piperacillin and Tazobactam in gel form is applied using a syringe and a flexible blunt needle into the periodontal pockets 24 hours after the non-surgical periodontal therapy. After administration, the dry field should be maintained for 5 minutes and the patient should not rinse the oral cavity for 15 minutes.
Piperacillin and Tazobactam in gel form: After non-surgical periodontal treatment, the test group will receive local antibiotics.
|
Open- Label Systemic Antibotic Group
n=19 Participants
Amoxicillin (500mg, 3 times a day, 7 days) and Metronidazole (400mg, 3 times a day, 7 days) per os at the beginning of non-surgical treatment.
Amoxicillin and Metronidazole: After non-surgical periodontal treatment, the control group will receive systemic antibiotics.
|
|---|---|---|
|
Changes in Relative Expression Levels of IL-17
IL-17 baseline
|
0.008072 ng/mL
Standard Deviation 0.004611
|
0.007164 ng/mL
Standard Deviation 0.008121
|
|
Changes in Relative Expression Levels of IL-17
IL-17 6 months
|
0.007358 ng/mL
Standard Deviation 0.005917
|
0.00455 ng/mL
Standard Deviation 0.00391
|
Adverse Events
Open- Label Local Antibiotic Group
Open- Label Systemic Antibotic Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Assistant Professor Dr. Iva Milinkovic
School Of Dental Medicine, University Of Belgrade, Department of Periodontology and Oral Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place