NCT03375372

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2003

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2005

Completed
12.5 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
Last Updated

December 18, 2017

Status Verified

November 1, 2017

Enrollment Period

1.3 years

First QC Date

December 6, 2017

Last Update Submit

December 11, 2017

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (10)

  • 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 Outcomes (1)

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

    6 months post S&RP

Study Arms (2)

Group 1 (Treatment Group)

ACTIVE COMPARATOR

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)

Group 2 (Delayed treatment)

NO INTERVENTION

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.

Interventions

Scaling and Root Planing (S&RP)PROCEDURE

dental Scaling and Root Planing and oral hygiene regimen

Also known as: Scaling & Root Planing (S&RP)
Group 1 (Treatment Group)

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • Steven Offenbacher, DDS PhD MMsc

    Chair of UNC Periodontology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2017

First Posted

December 18, 2017

Study Start

April 11, 2003

Primary Completion

August 1, 2004

Study Completion

June 4, 2005

Last Updated

December 18, 2017

Record last verified: 2017-11