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Completed

NCT Number: NCT03375372

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scaling and Root Planing (S&RP)

Procedure

dental Scaling and Root Planing and oral hygiene regimen

Other names: Scaling & Root Planing (S&RP)

Primary outcomes

  1. Effects of S&RP & OHR on C-Reactive protein

    Time frame: 6 months post S&RP

    Delta log value pg/ml 6 months post S&RP & OHR

  2. Effects of S&RP & OHR on HDL cholesterol

    Time frame: 6 months post S&RP

    Delta log value mg/dL 6 months post S&RP & OHR

  3. Effects of S&RP & OHR on LDL cholesterol

    Time frame: 6 months post S&RP

    Delta log value mg/dL 6 months post S&RP & OHR

  4. Effects of S&RP & OHR on VLDL cholesterol

    Time frame: 6 months post S&RP

    Delta log value mg/dL post S&RP & OHR

  5. Effects of S&RP & OHR on Triglycerides

    Time frame: 6 months post S&RP

    Delta log value mg/dL 6 months post S&RP & OHR

  6. Effects of S&RP & OHR on sCD-14

    Time frame: 6 months post S&RP

    Delta log value µg/ml 6 months post S&RP & OHR

  7. Effects of S&RP & OHR on Homocysteine

    Time frame: 6 months post S&RP

    Delta log value μmol/L 6 months post S&RP & OHR

  8. Effects of S&RP & OHR on 8-isoprostane

    Time frame: 6 months post S&RP

    Delta log value pg/ml 6 months post S&RP & OHR

  9. Effects of S&RP & OHR on sICAM

    Time frame: 6 months post S&RP

    Delta log value pg/ml 6 months post S&RP & OHR

  10. Effects of S&RP & OHR on Apolipoprotein A

    Time frame: 6 months post S&RP

    Delta log value mg/dL 6 months post S&RP & OHR

Secondary outcomes

  1. Relationship between S&RP and OHR on PGE2 & IL-1beta

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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

Acronym: BCU2

Important dates

Study start
2003
Primary completion
2004
Study completion
2005
First posted
Dec 18, 2017
Registry last updated
Dec 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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