Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers
2 other identifiers
interventional
146
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2003
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 1, 2003
CompletedFirst Posted
Study publicly available on registry
August 5, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
April 22, 2013
CompletedApril 22, 2013
March 1, 2013
6 years
August 1, 2003
December 11, 2012
March 6, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Mean Clinical Attachment Level.
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
Study Arms (3)
Scaling and root planing alone
PLACEBO COMPARATORFull mouth scaling and root planing (SRP) alone plus a placebo pill taken twice daily for 2 weeks.
SRP + Metronidazole
ACTIVE COMPARATORFull mouth Scaling and Root Planing plus Metronidazole (MET) 250 mg tid x 14 days
SRP + MET + Amoxicillin + Doxycycline
ACTIVE COMPARATORFull 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
Interventions
Scaling and root planning (SRP) is the mechanical debridement of the tooth and root surfaces and is standard of care in periodontal therapy.
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.
Amoxicillin (AMOX) is a broad spectrum antibiotic and was prescribed at 500 mg tid for 14d.
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.
Eligibility Criteria
You may qualify if:
- \> 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).
You may not qualify if:
- \> 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Periodontology
Cambridge, Massachusetts, 02142, United States
Related Publications (1)
Khattri S, Kumbargere Nagraj S, Arora A, Eachempati P, Kusum CK, Bhat KG, Johnson TM, Lodi G. Adjunctive systemic antimicrobials for the non-surgical treatment of periodontitis. Cochrane Database Syst Rev. 2020 Nov 16;11(11):CD012568. doi: 10.1002/14651858.CD012568.pub2.
PMID: 33197289DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ricardo P Teles, DDS, DMSc
- Organization
- The Forsyth Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Haffajee, DDS
Boston, MA
- PRINCIPAL INVESTIGATOR
Ricardo Teles, DDS, DMSc
The Forsyth Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2003
First Posted
August 5, 2003
Study Start
July 1, 2003
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
April 22, 2013
Results First Posted
April 22, 2013
Record last verified: 2013-03