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Control of Periodontal Infections

This study has been completed.
Sponsor:
Collaborators:
University of Goteberg, Sweden
Boston University
Information provided by:
The Forsyth Institute
ClinicalTrials.gov Identifier:
NCT01098448
First received: April 1, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted

April 1, 2010
April 1, 2010
September 1999
December 2004   (final data collection date for primary outcome measure)
Clinical Attachment Level Gain [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Probing pocket depth reduction [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Control of Periodontal Infections
Control of Periodontal Infections

The purpose of this study is to test combined effects of scaling and root planing with periodontal surgery, systemically administered amoxicillin and metronidazole, and/or local tetracycline on pocket depth reduction and attachment level "gain" in patients with chronic periodontitis.

In this 2x2x2 factorial design study, 229 moderate to advanced chronic periodontitis patients stratified according to current smoking status were recruited in USA and Sweden. Patients were randomly assigned to 8 groups, all of which were treated by SRP plus none, one, two or three adjunctive treatments. Thus, patients were assigned to groups that did or did not receive Surg, LAb, SAb or LAb+SAb (All) providing 8 treatment combinations (Surg + All, Surg + SAb, Surg + LAb, Surg alone, SRP + All, SRP + SAb, SRP + LAb, SRP alone). Clinical, microbiological and immunological measurements were taken for 2 years (at baseline, 3, 6, 12, 18 and 24 months). To focus on changes diseased sites, analysis was restricted to sites with baseline pocket depth greater than 5 mm. (also, these were the only sites treated by LAb). In this report, main effects and interactions were evaluated for PD reduction and AL gain two years post therapy for 187 of patients. Mean values were computed for each treatment group and averages after 2 years were compared to baseline by ANOVA. Factorial ANCOVA was used to examine significance of differences between Surg or not, SAb or not and LAb or not for PD reduction and AL gain using baseline attachment level or pocket depth as covariates and including current smoking as a factor.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Periodontitis
  • Other: scaling and root planing
    scaling and root planing as a single therapy
  • Drug: local tetracycline
    local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets >5mm
  • Drug: systemic metronidazole and amoxicillin
    systemic metronidazole (250 mg tid x 14) and amoxicillin (500 mg bid x 14
  • Other: surgery
    periodontal surgery in residual pockets of >4mm
  • Drug: local antibiotics and systemic metronidazole and amoxicillin
    1.7 mg/tooth tetracycline fiber plus metronidazole (250 mg tid x14d)and amoxicillin (500 mg bid x 14d)
  • Other: local tetracycline and periodontal surgery
    local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets >5mm and periodontal surgery in residual pockets of >4mm
  • Other: periodontal surgery and systemic metronidazole and amoxicillin
    surgery in residual pockets >4mm and metronidazole (250mg tidx14d) and amoxicillin (500mg bidx14d)
  • Other: surgery, local tetracycline, systemic metronidazole and amoxicillin
    periodontal surgery in residual pockets >4mm, tetracycline ibers releasing approximately 1.7 mg/tooth in pockets >5mm, systemic metronidazlo (250mg tidx14d) and amoxicillin (500 mg bidx14d)
  • Active Comparator: Scaling and root planing
    scaling and root planing as a solo therapy
    Intervention: Other: scaling and root planing
  • Experimental: Periodontal surgery
    Intervention: Other: surgery
  • Experimental: systemic antibiotics
    Intervention: Drug: systemic metronidazole and amoxicillin
  • Experimental: Local delivery of tetracycline
    Intervention: Drug: local tetracycline
  • Experimental: local antibiotic and systemic antibiotics
    Intervention: Drug: local antibiotics and systemic metronidazole and amoxicillin
  • Experimental: local antibiotics and surgery
    Intervention: Other: local tetracycline and periodontal surgery
  • Experimental: systemic antibiotics and surgery
    Intervention: Other: periodontal surgery and systemic metronidazole and amoxicillin
  • Experimental: local and systemic antibiotics and surgery
    Intervention: Other: surgery, local tetracycline, systemic metronidazole and amoxicillin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
187
December 2004
December 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • greater than 20 years of age
  • had a least 15 natural teeth
  • in good general health
  • at least 4 teeth with pockets > 6 mm
  • at least 8 teeth with AL > 3 mm at baseline

Exclusion Criteria:

  • pregnant or nursing (if female)
  • having antibiotic or periodontal therapy in the previous three months
  • systemic conditions that would affect the course of periodontal disease
  • systemic conditions that required antibiotic coverage
  • allergic to drugs used in the study
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01098448
NIDCR-012861
No
Sigmund Socransky, The Forsyth Institute
The Forsyth Institute
  • University of Goteberg, Sweden
  • Boston University
Principal Investigator: J Max Goodson, DDS, PhD The Forsyth Institute
Principal Investigator: Anne D Haffajee, BDS The Forsyth Institute
The Forsyth Institute
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP