Trial Outcomes & Findings for Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis (NCT NCT02969928)
NCT ID: NCT02969928
Last Updated: 2021-12-28
Results Overview
Evaluate the difference between baseline and 6 months CAL measures.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
46 participants
Primary outcome timeframe
Baseline, 3 and 6 months
Results posted on
2021-12-28
Participant Flow
Participant milestones
| Measure |
Amoxicillin and Metronidazole
In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Amoxicillin: Administration of Amoxicillin 500mg tid for 7 days.
Metronidazole: Administration of Metronidazole 400mg tid for 7 days.
|
Clarithromycin
In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Clarithromycin: Administration of Clarithromycin 500mg bid for 7 days
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis
Baseline characteristics by cohort
| Measure |
Amoxicillin and Metronidazole
n=23 Participants
In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Amoxicillin: Administration of Amoxicillin 500mg tid for 7 days.
Metronidazole: Administration of Metronidazole 400mg tid for 7 days.
|
Clarithromycin
n=23 Participants
In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Clarithromycin: Administration of Clarithromycin 500mg bid for 7 days
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 and 6 monthsEvaluate the difference between baseline and 6 months CAL measures.
Outcome measures
| Measure |
Amoxicillin and Metronidazole
n=23 Participants
In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Amoxicillin: Administration of Amoxicillin 500mg tid for 7 days.
Metronidazole: Administration of Metronidazole 400mg tid for 7 days.
|
Clarithromycin
n=23 Participants
In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Clarithromycin: Administration of Clarithromycin 500mg bid for 7 days
|
|---|---|---|
|
Change in Clinical Attachment Level (CAL)
Baseline
|
3.69 mm
Standard Deviation 0.7
|
3.62 mm
Standard Deviation 0.4
|
|
Change in Clinical Attachment Level (CAL)
3 months
|
2.4 mm
Standard Deviation 0.5
|
3 mm
Standard Deviation 0.4
|
|
Change in Clinical Attachment Level (CAL)
6 months
|
3 mm
Standard Deviation 0.5
|
3 mm
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Baseline, 3 and 6 monthsEvaluate the difference between baseline and 6 months PB measures.
Outcome measures
| Measure |
Amoxicillin and Metronidazole
n=23 Participants
In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Amoxicillin: Administration of Amoxicillin 500mg tid for 7 days.
Metronidazole: Administration of Metronidazole 400mg tid for 7 days.
|
Clarithromycin
n=23 Participants
In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Clarithromycin: Administration of Clarithromycin 500mg bid for 7 days
|
|---|---|---|
|
Change in Probing Depth (PB)
Baseline
|
3.44 mm
Standard Deviation 0.6
|
3.41 mm
Standard Deviation 0.4
|
|
Change in Probing Depth (PB)
3 months
|
2.5 mm
Standard Deviation 0.3
|
2.7 mm
Standard Deviation 0.2
|
|
Change in Probing Depth (PB)
6 months
|
2.6 mm
Standard Deviation 0.3
|
2.7 mm
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: Baseline, 3 and 6 monthsEvaluate the difference between baseline and 6 months BoP measures.
Outcome measures
| Measure |
Amoxicillin and Metronidazole
n=23 Participants
In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Amoxicillin: Administration of Amoxicillin 500mg tid for 7 days.
Metronidazole: Administration of Metronidazole 400mg tid for 7 days.
|
Clarithromycin
n=23 Participants
In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Clarithromycin: Administration of Clarithromycin 500mg bid for 7 days
|
|---|---|---|
|
Change in Bleeding on Probe (BoP)
Baseline
|
53.4 % of sites with bleeding on probe
Standard Deviation 17.4
|
43.7 % of sites with bleeding on probe
Standard Deviation 8.3
|
|
Change in Bleeding on Probe (BoP)
3 months
|
30.2 % of sites with bleeding on probe
Standard Deviation 9.3
|
24.8 % of sites with bleeding on probe
Standard Deviation 9.8
|
|
Change in Bleeding on Probe (BoP)
6 months
|
27.3 % of sites with bleeding on probe
Standard Deviation 8.3
|
23.3 % of sites with bleeding on probe
Standard Deviation 9.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One week post treatmentAfter 7 days of periodontal treatment, patients will be asked to return any medication not taken and/or the empty bottles. The number of pills not taken by the subject will be documented in order to evaluate compliance.
Outcome measures
| Measure |
Amoxicillin and Metronidazole
n=23 Participants
In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Amoxicillin: Administration of Amoxicillin 500mg tid for 7 days.
Metronidazole: Administration of Metronidazole 400mg tid for 7 days.
|
Clarithromycin
n=23 Participants
In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Clarithromycin: Administration of Clarithromycin 500mg bid for 7 days
|
|---|---|---|
|
Compliance
# of patients that did not take ≥1 pills
|
3 Participants
|
4 Participants
|
|
Compliance
# of patients that interrupted the drug intake
|
2 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One week post treatmentPatients will be instructed to fill a self-report form about any possible adverse effects in order to help evaluate their adherence to the systemic antimicrobial regimen.
Outcome measures
| Measure |
Amoxicillin and Metronidazole
n=23 Participants
In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Amoxicillin: Administration of Amoxicillin 500mg tid for 7 days.
Metronidazole: Administration of Metronidazole 400mg tid for 7 days.
|
Clarithromycin
n=23 Participants
In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Clarithromycin: Administration of Clarithromycin 500mg bid for 7 days
|
|---|---|---|
|
Adverse Effects That May be Related to Antibiotic Treatment
Headache
|
1 Participants
|
2 Participants
|
|
Adverse Effects That May be Related to Antibiotic Treatment
Stomach pain
|
4 Participants
|
3 Participants
|
|
Adverse Effects That May be Related to Antibiotic Treatment
Nausea/vomiting
|
3 Participants
|
6 Participants
|
|
Adverse Effects That May be Related to Antibiotic Treatment
Metallic taste
|
7 Participants
|
13 Participants
|
|
Adverse Effects That May be Related to Antibiotic Treatment
Diarrhea/abdominal pain
|
3 Participants
|
3 Participants
|
|
Adverse Effects That May be Related to Antibiotic Treatment
Drowsiness
|
2 Participants
|
3 Participants
|
|
Adverse Effects That May be Related to Antibiotic Treatment
Itching
|
1 Participants
|
0 Participants
|
|
Adverse Effects That May be Related to Antibiotic Treatment
Skin wounds
|
0 Participants
|
0 Participants
|
|
Adverse Effects That May be Related to Antibiotic Treatment
None
|
5 Participants
|
5 Participants
|
Adverse Events
Amoxicillin and Metronidazole
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Clarithromycin
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Amoxicillin and Metronidazole
n=23 participants at risk
In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Amoxicillin: Administration of Amoxicillin 500mg tid for 7 days.
Metronidazole: Administration of Metronidazole 400mg tid for 7 days.
|
Clarithromycin
n=23 participants at risk
In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Clarithromycin: Administration of Clarithromycin 500mg bid for 7 days
|
|---|---|---|
|
General disorders
Headache
|
4.3%
1/23 • during 7 days post-treatment
7 days after the therapy patients returned to fill out a self-report form about 8 possible adverse effects resulting from the antibiotic intake, based on Martys: Headache, Stomach pain, Nausea/vomiting, Metallic taste, Diarrhea/ abdominal pain, Drowsiness, Itching and Skin wounds.
|
8.7%
2/23 • during 7 days post-treatment
7 days after the therapy patients returned to fill out a self-report form about 8 possible adverse effects resulting from the antibiotic intake, based on Martys: Headache, Stomach pain, Nausea/vomiting, Metallic taste, Diarrhea/ abdominal pain, Drowsiness, Itching and Skin wounds.
|
|
Gastrointestinal disorders
Stomach pain
|
17.4%
4/23 • during 7 days post-treatment
7 days after the therapy patients returned to fill out a self-report form about 8 possible adverse effects resulting from the antibiotic intake, based on Martys: Headache, Stomach pain, Nausea/vomiting, Metallic taste, Diarrhea/ abdominal pain, Drowsiness, Itching and Skin wounds.
|
13.0%
3/23 • during 7 days post-treatment
7 days after the therapy patients returned to fill out a self-report form about 8 possible adverse effects resulting from the antibiotic intake, based on Martys: Headache, Stomach pain, Nausea/vomiting, Metallic taste, Diarrhea/ abdominal pain, Drowsiness, Itching and Skin wounds.
|
|
General disorders
Nausea/vomiting
|
13.0%
3/23 • during 7 days post-treatment
7 days after the therapy patients returned to fill out a self-report form about 8 possible adverse effects resulting from the antibiotic intake, based on Martys: Headache, Stomach pain, Nausea/vomiting, Metallic taste, Diarrhea/ abdominal pain, Drowsiness, Itching and Skin wounds.
|
26.1%
6/23 • during 7 days post-treatment
7 days after the therapy patients returned to fill out a self-report form about 8 possible adverse effects resulting from the antibiotic intake, based on Martys: Headache, Stomach pain, Nausea/vomiting, Metallic taste, Diarrhea/ abdominal pain, Drowsiness, Itching and Skin wounds.
|
|
General disorders
Metallic taste
|
30.4%
7/23 • during 7 days post-treatment
7 days after the therapy patients returned to fill out a self-report form about 8 possible adverse effects resulting from the antibiotic intake, based on Martys: Headache, Stomach pain, Nausea/vomiting, Metallic taste, Diarrhea/ abdominal pain, Drowsiness, Itching and Skin wounds.
|
56.5%
13/23 • during 7 days post-treatment
7 days after the therapy patients returned to fill out a self-report form about 8 possible adverse effects resulting from the antibiotic intake, based on Martys: Headache, Stomach pain, Nausea/vomiting, Metallic taste, Diarrhea/ abdominal pain, Drowsiness, Itching and Skin wounds.
|
|
Gastrointestinal disorders
Diarrhea/ abdominal pain
|
13.0%
3/23 • during 7 days post-treatment
7 days after the therapy patients returned to fill out a self-report form about 8 possible adverse effects resulting from the antibiotic intake, based on Martys: Headache, Stomach pain, Nausea/vomiting, Metallic taste, Diarrhea/ abdominal pain, Drowsiness, Itching and Skin wounds.
|
13.0%
3/23 • during 7 days post-treatment
7 days after the therapy patients returned to fill out a self-report form about 8 possible adverse effects resulting from the antibiotic intake, based on Martys: Headache, Stomach pain, Nausea/vomiting, Metallic taste, Diarrhea/ abdominal pain, Drowsiness, Itching and Skin wounds.
|
|
General disorders
Drowsiness
|
8.7%
2/23 • during 7 days post-treatment
7 days after the therapy patients returned to fill out a self-report form about 8 possible adverse effects resulting from the antibiotic intake, based on Martys: Headache, Stomach pain, Nausea/vomiting, Metallic taste, Diarrhea/ abdominal pain, Drowsiness, Itching and Skin wounds.
|
13.0%
3/23 • during 7 days post-treatment
7 days after the therapy patients returned to fill out a self-report form about 8 possible adverse effects resulting from the antibiotic intake, based on Martys: Headache, Stomach pain, Nausea/vomiting, Metallic taste, Diarrhea/ abdominal pain, Drowsiness, Itching and Skin wounds.
|
|
Skin and subcutaneous tissue disorders
Itching
|
4.3%
1/23 • during 7 days post-treatment
7 days after the therapy patients returned to fill out a self-report form about 8 possible adverse effects resulting from the antibiotic intake, based on Martys: Headache, Stomach pain, Nausea/vomiting, Metallic taste, Diarrhea/ abdominal pain, Drowsiness, Itching and Skin wounds.
|
0.00%
0/23 • during 7 days post-treatment
7 days after the therapy patients returned to fill out a self-report form about 8 possible adverse effects resulting from the antibiotic intake, based on Martys: Headache, Stomach pain, Nausea/vomiting, Metallic taste, Diarrhea/ abdominal pain, Drowsiness, Itching and Skin wounds.
|
|
Skin and subcutaneous tissue disorders
Skin wounds
|
0.00%
0/23 • during 7 days post-treatment
7 days after the therapy patients returned to fill out a self-report form about 8 possible adverse effects resulting from the antibiotic intake, based on Martys: Headache, Stomach pain, Nausea/vomiting, Metallic taste, Diarrhea/ abdominal pain, Drowsiness, Itching and Skin wounds.
|
0.00%
0/23 • during 7 days post-treatment
7 days after the therapy patients returned to fill out a self-report form about 8 possible adverse effects resulting from the antibiotic intake, based on Martys: Headache, Stomach pain, Nausea/vomiting, Metallic taste, Diarrhea/ abdominal pain, Drowsiness, Itching and Skin wounds.
|
Additional Information
Dr Mauro Pedrine Santamaria
São Paulo State University - Unesp
Phone: +5516981937777
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place