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Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers

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ClinicalTrials.gov Identifier: NCT00066066
Recruitment Status : Completed
First Posted : August 5, 2003
Results First Posted : April 22, 2013
Last Update Posted : April 22, 2013
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
The Forsyth Institute

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Periodontitis
Periodontal Diseases
Interventions: Procedure: Scaling and root planing
Drug: Metronidazole
Drug: Amoxicillin
Drug: Doxycycline

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Only 5 subjects dropped prior to randomization due to conflicts in scheduling or unable to adhere to the monitoring plan.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Scaling and Root Planing (SRP) Only NonSmokers   SRP Only Smokers   SRP and Metronidazole (MET) NonSmokers   SRP and Metronidazole (MET) Smokers   SRP and Amoxicillin, MET, Local Tetracycline NonSmokers   SRP and Amoxicillin, MET, Local Tetracycline Smokers
STARTED   27   22   30   20   27   20 
Baseline   27   22   30   20   27   20 
3 Month   21   17   23   16   22   15 
6 Month   19   13   23   13   21   14 
12 Month   18   11   21   11   19   9 
COMPLETED   21 [1]   18 [2]   23 [3]   16 [4]   24 [5]   15 [6] 
NOT COMPLETED   6   4   7   4   3   5 
Lost to Follow-up                6                4                7                4                3                5 
[1] 27 enrolled, 21 analyzed,18 subjects had complete data,3 subjects had data carried forward.
[2] 22 enrolled, 18 analyzed,11 subjects had complete data,7 subjects had data carried forward.
[3] 30 enrolled, 23 analyzed,21 subjects had complete data,2 subjects had data carried forward.
[4] 20 enrolled, 16 analyzed,11 subjects had complete data,5 subjects had data carried forward.
[5] 27 enrolled, 24 analyzed,19 subjects had complete data,5 subjects had data carried forward.
[6] 20 enrolled, 15 analyzed,9 subjects had complete data,6 subjects had data carried forward.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Scaling and Root Planing (SRP) Only 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)

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

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 Total of all reporting groups

Baseline Measures
   Scaling and Root Planing (SRP) Only   SRP and Metronidazole (MET)   SRP and Amoxicillin, MET and Locally Delivered Tetracycline   Total 
Overall Participants Analyzed 
[Units: Participants]
 49   50   47   146 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   42   46   44   132 
>=65 years   7   4   3   14 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.3  (11.8)   50.3  (11.6)   48.0  (11.1)   49.5  (11.5) 
Gender 
[Units: Participants]
       
Female   21   23   20   64 
Male   28   27   27   82 
Region of Enrollment 
[Units: Participants]
       
United States   49   50   47   146 


  Outcome Measures

1.  Primary:   Change in Mean Clinical Attachment Level.   [ Time Frame: Baseline, 3, 6 and 12 months ]


  Serious Adverse Events

Time Frame Adverse event data was collected over the entire course of the study for each enrolled subject.
Additional Description No text entered.

Reporting Groups
  Description
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.


Serious Adverse Events
    Scaling and Root Planing (SRP) Only NonSmokers   SRP Only Smokers   SRP and Metronidazole (MET) NonSmokers   SRP and Metronidazole (MET) Smokers   SRP and Amoxicillin, MET, Local Tetracycline NonSmokers   SRP and Amoxicillin, MET, Local Tetracycline Smokers
Total, Serious Adverse Events             
# participants affected / at risk   1/27 (3.70%)   0/22 (0.00%)   2/30 (6.67%)   2/20 (10.00%)   3/27 (11.11%)   1/20 (5.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Death * [3]             
# participants affected / at risk   0/27 (0.00%)   0/22 (0.00%)   1/30 (3.33%)   0/20 (0.00%)   1/27 (3.70%)   0/20 (0.00%) 
# events   0   0   1   0   1   0 
Surgical and medical procedures             
hospitalizations †             
# participants affected / at risk   1/27 (3.70%)   0/22 (0.00%)   2/30 (6.67%)   2/20 (10.00%)   3/27 (11.11%)   1/20 (5.00%) 
# events   1   0   2   2   3   1 
Events were collected by systematic assessment
* Events were collected by non-systematic assessment
[3] One death was due to cancer - SRP/MET/NonSmoker Group One death due to unknown causes




  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ricardo P Teles, DDS, DMSc
Organization: The Forsyth Institute
phone: 617 892-8556
e-mail: rteles@forsyth.org



Responsible Party: The Forsyth Institute
ClinicalTrials.gov Identifier: NCT00066066     History of Changes
Other Study ID Numbers: NIDCR-14242
R01DE014242 ( U.S. NIH Grant/Contract )
First Submitted: August 1, 2003
First Posted: August 5, 2003
Results First Submitted: December 11, 2012
Results First Posted: April 22, 2013
Last Update Posted: April 22, 2013