Trial Outcomes & Findings for Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers (NCT NCT00066066)
NCT ID: NCT00066066
Last Updated: 2013-04-22
Results Overview
Periodontal diseases are clinically diagnosed by assessments of gingival inflammation and measurements of tissue destruction. The damage to the apparatus of support of the teeth is quantified using measurements of probing pocket depth (PD) and clinical attachment level (CAL). These measurements are obtained using a periodontal probe which is introduced into the gingival sulcus to determine the distance in millimeters from the gingival margin to the depth of the sulcus or pocket (PD). Since the gingival margin fluctuates in response to inflammation (hyperplasia) or might recede, a more accurate measure of loss of attachment is obtained using the CAL, which measures the distance from a "fixed" landmark on the tooth such as the cemento-enamel junction to the depth of the pocket. Changes in CAL from baseline were used to assess results obtained with the treatment of periodontal diseases.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
146 participants
Primary outcome timeframe
Baseline, 3, 6 and 12 months
Results posted on
2013-04-22
Participant Flow
Subjects with moderate to advanced chronic periodontitis were recruited to the clinical center at The Forsyth Institute. Subjects were recruited from the Boston area, subjects of any racial / ethnic group were accepted for study.
Only 5 subjects dropped prior to randomization due to conflicts in scheduling or unable to adhere to the monitoring plan.
Participant milestones
| Measure |
Scaling and Root Planing (SRP) Only NonSmokers
Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
|
SRP Only Smokers
Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
|
SRP and Metronidazole (MET) NonSmokers
In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species.
|
SRP and Metronidazole (MET) Smokers
In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species.
|
SRP and Amoxicillin, MET, Local Tetracycline NonSmokers
In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets \> 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally.
|
SRP and Amoxicillin, MET, Local Tetracycline Smokers
In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets \> 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
22
|
30
|
20
|
27
|
20
|
|
Overall Study
Baseline
|
27
|
22
|
30
|
20
|
27
|
20
|
|
Overall Study
3 Month
|
21
|
17
|
23
|
16
|
22
|
15
|
|
Overall Study
6 Month
|
19
|
13
|
23
|
13
|
21
|
14
|
|
Overall Study
12 Month
|
18
|
11
|
21
|
11
|
19
|
9
|
|
Overall Study
COMPLETED
|
21
|
18
|
23
|
16
|
24
|
15
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
7
|
4
|
3
|
5
|
Reasons for withdrawal
| Measure |
Scaling and Root Planing (SRP) Only NonSmokers
Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
|
SRP Only Smokers
Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
|
SRP and Metronidazole (MET) NonSmokers
In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species.
|
SRP and Metronidazole (MET) Smokers
In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species.
|
SRP and Amoxicillin, MET, Local Tetracycline NonSmokers
In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets \> 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally.
|
SRP and Amoxicillin, MET, Local Tetracycline Smokers
In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets \> 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
4
|
7
|
4
|
3
|
5
|
Baseline Characteristics
Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers
Baseline characteristics by cohort
| Measure |
Scaling and Root Planing (SRP) Only
n=49 Participants
Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
|
SRP and Metronidazole (MET)
n=50 Participants
In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species.
|
SRP and Amoxicillin, MET and Locally Delivered Tetracycline
n=47 Participants
In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets \> 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally.
|
Total
n=146 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Age Continuous
|
50.3 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
50.3 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
48.0 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
49.5 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
50 participants
n=7 Participants
|
47 participants
n=5 Participants
|
146 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3, 6 and 12 monthsPopulation: Of the 146 subjects, 117 were included in the analysis, who had 2 or fewer missing monitoring visits. 84 subjects had complete data, 23 subjects had one missing visit and 10 subjects had 2 missing visits. For the 33 subjects with missing visits, data were carried forward. 68 subjects were non smokers and 49 subjects were current smokers.
Periodontal diseases are clinically diagnosed by assessments of gingival inflammation and measurements of tissue destruction. The damage to the apparatus of support of the teeth is quantified using measurements of probing pocket depth (PD) and clinical attachment level (CAL). These measurements are obtained using a periodontal probe which is introduced into the gingival sulcus to determine the distance in millimeters from the gingival margin to the depth of the sulcus or pocket (PD). Since the gingival margin fluctuates in response to inflammation (hyperplasia) or might recede, a more accurate measure of loss of attachment is obtained using the CAL, which measures the distance from a "fixed" landmark on the tooth such as the cemento-enamel junction to the depth of the pocket. Changes in CAL from baseline were used to assess results obtained with the treatment of periodontal diseases.
Outcome measures
| Measure |
Scaling and Root Planing Only NonSmokers
n=21 Participants
Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
|
SRP Only Smokers
n=18 Participants
Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
|
SRP + Metronidazole NonSmokers
n=23 Participants
In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species.
|
SRP + Metronidazole Smokers
n=16 Participants
In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species.
|
SRP + MET + Amoxicillin + Doxycycline NonSmokers
n=24 Participants
In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets \> 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally.
|
SRP + MET + Amoxicillin + Doxycycline Smokers
n=15 Participants
In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets \> 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally.
|
|---|---|---|---|---|---|---|
|
Change in Mean Clinical Attachment Level.
Changes in mean CAL from baseline to 6 months
|
0.15 mm
Standard Error 0.06
|
0.19 mm
Standard Error 0.05
|
0.19 mm
Standard Error 0.07
|
0.13 mm
Standard Error 0.07
|
0.34 mm
Standard Error 0.07
|
0.40 mm
Standard Error 0.08
|
|
Change in Mean Clinical Attachment Level.
Changes in mean CAL from baseline to 12 months
|
0.11 mm
Standard Error 0.05
|
0.24 mm
Standard Error 0.05
|
0.26 mm
Standard Error 0.06
|
0.17 mm
Standard Error 0.09
|
0.41 mm
Standard Error 0.07
|
0.39 mm
Standard Error 0.08
|
|
Change in Mean Clinical Attachment Level.
Changes in mean CAL from baseline to 3 months
|
0.11 mm
Standard Error 0.06
|
0.10 mm
Standard Error 0.04
|
0.21 mm
Standard Error 0.05
|
0.08 mm
Standard Error 0.06
|
0.29 mm
Standard Error 0.07
|
0.28 mm
Standard Error 0.06
|
Adverse Events
Scaling and Root Planing (SRP) Only NonSmokers
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
SRP Only Smokers
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
SRP and Metronidazole (MET) NonSmokers
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
SRP and Metronidazole (MET) Smokers
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
SRP and Amoxicillin, MET, Local Tetracycline NonSmokers
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
SRP and Amoxicillin, MET, Local Tetracycline Smokers
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Scaling and Root Planing (SRP) Only NonSmokers
n=27 participants at risk
Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
|
SRP Only Smokers
n=22 participants at risk
Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
|
SRP and Metronidazole (MET) NonSmokers
n=30 participants at risk
In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species.
|
SRP and Metronidazole (MET) Smokers
n=20 participants at risk
In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species.
|
SRP and Amoxicillin, MET, Local Tetracycline NonSmokers
n=27 participants at risk
In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets \> 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally.
|
SRP and Amoxicillin, MET, Local Tetracycline Smokers
n=20 participants at risk
In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets \> 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally.
|
|---|---|---|---|---|---|---|
|
Surgical and medical procedures
hospitalizations
|
3.7%
1/27 • Number of events 1 • Adverse event data was collected over the entire course of the study for each enrolled subject.
|
0.00%
0/22 • Adverse event data was collected over the entire course of the study for each enrolled subject.
|
6.7%
2/30 • Number of events 2 • Adverse event data was collected over the entire course of the study for each enrolled subject.
|
10.0%
2/20 • Number of events 2 • Adverse event data was collected over the entire course of the study for each enrolled subject.
|
11.1%
3/27 • Number of events 3 • Adverse event data was collected over the entire course of the study for each enrolled subject.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected over the entire course of the study for each enrolled subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
|
0.00%
0/27 • Adverse event data was collected over the entire course of the study for each enrolled subject.
|
0.00%
0/22 • Adverse event data was collected over the entire course of the study for each enrolled subject.
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected over the entire course of the study for each enrolled subject.
|
0.00%
0/20 • Adverse event data was collected over the entire course of the study for each enrolled subject.
|
3.7%
1/27 • Number of events 1 • Adverse event data was collected over the entire course of the study for each enrolled subject.
|
0.00%
0/20 • Adverse event data was collected over the entire course of the study for each enrolled subject.
|
Other adverse events
| Measure |
Scaling and Root Planing (SRP) Only NonSmokers
n=27 participants at risk
Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
|
SRP Only Smokers
n=22 participants at risk
Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
|
SRP and Metronidazole (MET) NonSmokers
n=30 participants at risk
In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species.
|
SRP and Metronidazole (MET) Smokers
n=20 participants at risk
In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species.
|
SRP and Amoxicillin, MET, Local Tetracycline NonSmokers
n=27 participants at risk
In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets \> 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally.
|
SRP and Amoxicillin, MET, Local Tetracycline Smokers
n=20 participants at risk
In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets \> 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Upset
|
29.6%
8/27 • Number of events 8 • Adverse event data was collected over the entire course of the study for each enrolled subject.
|
18.2%
4/22 • Number of events 4 • Adverse event data was collected over the entire course of the study for each enrolled subject.
|
33.3%
10/30 • Number of events 10 • Adverse event data was collected over the entire course of the study for each enrolled subject.
|
15.0%
3/20 • Number of events 3 • Adverse event data was collected over the entire course of the study for each enrolled subject.
|
22.2%
6/27 • Number of events 6 • Adverse event data was collected over the entire course of the study for each enrolled subject.
|
25.0%
5/20 • Number of events 5 • Adverse event data was collected over the entire course of the study for each enrolled subject.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place