Effects of Periodontal Therapy on Markers of Acute Phase Response, Oxidative Stress (BCU2)

Effects of Periodontal Therapy on Markers of Acute Phase Response (APR), Oxidative Stress: Phase II {Formerly UNC Biomedical IRB Study # DENT-2019}

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: Scaling and Root Planing (S&RP)

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 Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group 1 (Treatment Group); Subjects receive intervention of Scaling and Root Planing (S&RP) procedure under local anesthesia, plus a specified Oral Hygiene Regimen (OHR)	Procedure: Scaling and Root Planing (S&RP); dental Scaling and Root Planing and oral hygiene regimen; Other Names: Scaling & Root Planing (S&RP)
NO_INTERVENTION: Group 2 (Delayed treatment); Subjects have delayed treatment scaling and root planing procedure and OHR at 36 weeks (Final visit) These subjects are not followed beyond completion of the treatment.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between S&RP and OHR on PGE2 & IL-1beta	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.	6 months post S&RP

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Steven Offenbacher, DDS PhD MMsc, Chair of UNC Periodontology

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 11, 2003
• Primary Completion (ACTUAL): August 1, 2004
• Study Completion (ACTUAL): June 4, 2005

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (ACTUAL): December 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 18, 2017
• Last Update Submitted That Met QC Criteria: December 11, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Acute-Phase Reaction
• Other Study ID Numbers: 02-1516

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED