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

March 6, 2013 updated by: The Forsyth Institute
The purpose of this study is to determine in current and non-smokers the clinical and microbiological effects of 3 therapies: scaling and root planing (SRP) alone; SRP in combination with the orally administered antibiotic metronidazole; and SRP with the orally administered antibiotics metronidazole and amoxicillin along with the locally delivered antibiotic doxycycline at periodontal pockets >= 4 mm.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cigarette smokers have more severe periodontal disease and more widespread colonization by periodontal pathogens than non smokers. In addition, smokers respond less well to periodontal therapies, particularly mechanical therapies such as scaling and root planing (SRP) and surgery. Recent data from our laboratory have indicated that treatment that included antibiotics produced a better clinical effect in smokers than mechanical therapy alone. Thus, the purpose of the present investigation is to compare the immediate and long-term effects of 3 periodontal therapies on clinical, microbiological and host parameters in current and non smokers. In this double blind, placebo-controlled, randomized study, 108 current smokers and 108 non smokers will be randomly assigned to 1 of 3 treatment groups: SRP alone; SRP + systemically administered metronidazole; SRP + systemically administered amoxicillin and metronidazole and local delivery of doxycycline at pockets > 4 mm. Plaque Index, Gingival Index, % of sites with bleeding on probing, suppuration, pocket depth and attachment level will be measured at 6 sites per tooth at all teeth excluding 3rd molars at baseline, 3, 6, 12, 18 and 24 months. Subgingival plaque samples taken from the mesial aspect of each tooth at the same time points will be analyzed individually for their content of 40 subgingival species using checkerboard DNA-DNA hybridization. Antibody levels to 20 subgingival species will be measured in serum samples taken at baseline, 6 and 24 months. Levels of IL-1b, IL-10 and IFNg will be measured in GCF samples taken from the 4 deepest pockets at baseline, 3, 6 and 24 months. The major hypothesis to be tested is whether smokers respond better to periodontal therapies that include 1 or more antibiotics. Other hypotheses will test whether host and microbiological parameters differ between smokers and non smokers and if such parameters are comparably altered after therapy in both groups. The results will be of immediate clinical benefit to the large segment of periodontal patients who smoke cigarettes. Smokers make up 26 - 30% of the adult population and form a disproportionately high segment of the population requiring periodontal treatment. They may have special needs in terms of periodontal therapy which should be clarified by the proposed investigation. In addition, the cigarette smoker is an example of a periodontal patient who is "compromised" in terms of his/her ability to cope with infectious diseases. The proposed investigation should provide a model to examine methods that could be useful in treating compromised patients whether compromised by harmful habits such as smoking, systemic disease or genetic background.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
146

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02142
        • Department of Periodontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • > 20 teeth
  • > 5% sites (approx. 8 sites) with pocket depth > 4 mm and / or 5% sites with attachment level > 4 mm and mean AL < 4.5 mm and mean PD < 3.9 mm (not including tooth brush abrasions).

Exclusion Criteria:

  • > 50% of sites with pocket depth or attachment level > 4 mm
  • Pregnancy or nursing
  • Periodontal or antibiotic therapy in the previous 6 months
  • Any systemic condition which might influence the course of periodontal disease or treatment (e.g. diabetes, AIDS)
  • Any systemic condition which requires antibiotic coverage for routine periodontal procedures (e.g. heart conditions, joint replacements etc.)
  • Liver disease
  • Any known allergy to amoxicillin, metronidazole or doxycycline
  • Lactose intolerance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Scaling and root planing alone
Full mouth scaling and root planing (SRP) alone plus a placebo pill taken twice daily for 2 weeks.
Procedure: Scaling and root planing
Scaling and root planning (SRP) is the mechanical debridement of the tooth and root surfaces and is standard of care in periodontal therapy.
Active Comparator: SRP + Metronidazole
Full mouth Scaling and Root Planing plus Metronidazole (MET) 250 mg tid x 14 days
Drug: Metronidazole
Metronidazole (MET) is an antibiotic that is particularly effective against Gram negative bacterial species. The dose for this study is: 250 mg tid x 14d.
Active Comparator: SRP + MET + Amoxicillin + Doxycycline
Full mouth Scaling and Root Planing plus Metronidazole (MET) 250 mg tid x 14 d and Amoxicillin (AMOX) 500 mg tid for 14 days and local drug delivery of Doxycycline (TET LDD) in pockets >4mm
Drug: Amoxicillin
Amoxicillin (AMOX) is a broad spectrum antibiotic and was prescribed at 500 mg tid for 14d.
Drug: Doxycycline
The ATRIDOX (doxycycline hyclate) ® product is a subgingival controlled-release product composed of a two syringe mixing system. Syringe A contains 450 mg of the ATRIGEL® Delivery System, which is a bioabsorbable, flowable polymeric formulation composed of 36.7% poly(DLlactide) (PLA) dissolved in 63.3% N-methyl-2-pyrrolidone (NMP). Syringe B contains 50 mg of doxycycline hyclate which is equivalent to 42.5 mg doxycycline. The constituted product is a pale yellow to yellow viscous liquid with a concentration of 10% of doxycycline hyclate. Upon contact with the crevicular fluid, the liquid product solidifies and then allows for controlled release of drug for a period of 7 days. Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline.
Other Names:
  • Atridox

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Mean Clinical Attachment Level.
Time Frame: Baseline, 3, 6 and 12 months
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.
Baseline, 3, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Forsyth Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anne Haffajee, DDS, Boston, MA
  • Principal Investigator: Ricardo Teles, DDS, DMSc, The Forsyth Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2003

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2003

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2003

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIDCR-14242
  • R01DE014242 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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