Effects of Periodontal Therapy on Markers of Acute Phase Response, Oxidative Stress
Condition: Periodontitis
MeSH terms: Periodontitis; Acute-Phase Reaction
Study type: Interventional

Summary: 
      This study began enrollment in 2003 with final report completed in October of 2015. This
      submission is being provided to acquire an NCT number.

      This study was successfully executed according to protocol with full enrollment and
      completion of 89.7% of subjects. Subjects were enrolled into a two arm study 1) Combined
      therapy (scaling and root planing plus Crest products) vs. 2) delayed treatment. Subjects
      were followed for 6 months and a wide and extensive battery of biological samples were
      collected to determine the effects of treatment on the local and systemic inflammatory
      response.
    

Detailed description: 
      The design for this study was a single-blinded, delayed treatment, controlled, randomized,
      clinical trial. A total of 106 subjects, 2 sets of 53 patients each in one of 2 arms, were
      enrolled. For both groups at 6 weeks, 3 months, and 6 months periodontal measures, gingival
      crevicular fluid, and plaque were taken using standardized techniques. Blood for serum was
      collected at each time point, plus at an additional 2 week visit. GCF samples were collected
      and analyzed for PGE2 and IL-1 to provide a mediator assessment of periodontal status.These
      GCF data and the clinical changes were used to assure that the therapy provided had resulted
      in a local therapeutic benefit. These data were primarily useful as it relates to changes in
      systemic levels of mediators.

      Subjects were recruited from the surrounding communities by means of flyer advertisements, as
      well as media advertisements in weekly newspapers and on the radio. Recruitment focused on
      subjects between the ages of 18 and 64 years with periodontal disease.

      The investigators excluded persons who have less than 20 teeth; who had any serious systemic
      disease including: auto-immune type disorders (i.e. systemic lupus erythematous),
      immunosuppression (chronic systemic c steroid use, cancer chemotherapy or HIV infection),
      chronic liver disease including hepatitis, or diabetes mellitus; extremely obese (BMI <40),
      are pregnant, or who abuse alcohol or drugs. Subjects were selected from periodontal
      screening examinations as having 4 or more sites with pocket depths of 5 or more mm and two
      or more sites with attachment loss of 3 mm or more and who required scaling and root planing.

      The Phase II set of 106 patients had periodontal therapy consisting of one of two treatments:

      Treatment 1: A 6-week observation period (treatment delay), then full-mouth scaling and root
      planing plus specific oral hygiene regimen (OHR) (Group 1);

      Treatment 2: A 6-week observation period (treatment delay), then a further 6-month
      observation period (delayed treatment), followed by scaling and root planing plus specific
      oral hygiene regimen (OHR) at 6 months (Group 2).
    

Intervention name(s): Scaling and Root Planing (S&RP)
Intervention type(s): Procedure
Intervention description(s): dental Scaling and Root Planing and oral hygiene regimen
Other intervention name(s): Scaling & Root Planing (S&RP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment