Effects of Periodontal Therapy on Markers of Acute Phase Response, Oxidative Stress

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Procedure: Scaling and Root Planing (S&RP)

• Registration Number: NCT03375372
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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).

Study Timeline

• Study Start: 2003-04-11
• Primary Completion: 2004-08-01
• Study Completion: 2005-06-04
• Status Verified: 2017-11
• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-11
• Last Update Submitted: 2017-12-11
• Study First Posted: 2017-12-18
• Last Update Posted: 2017-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• subjects with four or more periodontal pockets of five millimeters or greater and two or more sites with an clinical attachment loss of three millimeters or greater.

Exclusion Criteria

• subjects with less than 20 teeth
• subjects with serious systemic diseases (lupus, systemic erythematous), immunosuppression (chronic systemic steroid use, cancer, chemotherapy, or HIV infection), chronic liver disease including hepatitis or diabetes mellitus.
• Body Mass Index of of 40 or greater
• pregnant
• abuse alcohol or drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (Treatment Group)	Scaling and Root Planing (S&RP)	Subjects receive intervention of Scaling and Root Planing (S\&RP) procedure under local anesthesia, plus a specified Oral Hygiene Regimen (OHR)

Primary Outcome Measures

Name	Time	Method
Effects of S&RP & OHR on C-Reactive protein	6 months post S&RP	Delta log value pg/ml 6 months post S\&RP \& OHR
Effects of S&RP & OHR on HDL cholesterol	6 months post S&RP	Delta log value mg/dL 6 months post S\&RP \& OHR
Effects of S&RP & OHR on LDL cholesterol	6 months post S&RP	Delta log value mg/dL 6 months post S\&RP \& OHR
Effects of S&RP & OHR on VLDL cholesterol	6 months post S&RP	Delta log value mg/dL post S\&RP \& OHR
Effects of S&RP & OHR on Triglycerides	6 months post S&RP	Delta log value mg/dL 6 months post S\&RP \& OHR
Effects of S&RP & OHR on sCD-14	6 months post S&RP	Delta log value µg/ml 6 months post S\&RP \& OHR
Effects of S&RP & OHR on Homocysteine	6 months post S&RP	Delta log value μmol/L 6 months post S\&RP \& OHR
Effects of S&RP & OHR on 8-isoprostane	6 months post S&RP	Delta log value pg/ml 6 months post S\&RP \& OHR
Effects of S&RP & OHR on sICAM	6 months post S&RP	Delta log value pg/ml 6 months post S\&RP \& OHR
Effects of S&RP & OHR on Apolipoprotein A	6 months post S&RP	Delta log value mg/dL 6 months post S\&RP \& OHR

Secondary Outcome Measures

Name	Time	Method
Relationship between S&RP and OHR on PGE2 & IL-1beta	6 months post S&RP	to determine the relationship between the effects of S\&RP plus OHR on levels of systemic inflammation and local changes in periodontal status, GCF levels of PGE2 and IL-1 and the periodontal microbiota, quantifying the levels of 40 organisms.