PeriodontitisBCU2NCT03375372
Effects of Periodontal Therapy on Markers of Acute Phase Response, Oxidative Stress
A study testing Scaling and Root Planing (S&RP) in people with Periodontitis, run by University of North Carolina, Chapel Hill.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Scaling and Root Planing (S&RP)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 11 Apr 2003to 4 Jun 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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.
Read the 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).
- Conditions
- Periodontitis
- Being tested
- Scaling and Root Planing (S&RP)
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and Root Planing (S&RP)Procedure or surgery
Also called Scaling & Root Planing (S&RP)
dental Scaling and Root Planing and oral hygiene regimen
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of S&RP & OHR on C-Reactive protein
Delta log value pg/ml 6 months post S\&RP \& OHR
Measured: 6 months post S&RP
Effects of S&RP & OHR on HDL cholesterol
Delta log value mg/dL 6 months post S\&RP \& OHR
Measured: 6 months post S&RP
Effects of S&RP & OHR on LDL cholesterol
Delta log value mg/dL 6 months post S\&RP \& OHR
Measured: 6 months post S&RP
Effects of S&RP & OHR on VLDL cholesterol
Delta log value mg/dL post S\&RP \& OHR
Measured: 6 months post S&RP
Effects of S&RP & OHR on Triglycerides
Delta log value mg/dL 6 months post S\&RP \& OHR
Measured: 6 months post S&RP
Effects of S&RP & OHR on sCD-14
Delta log value µg/ml 6 months post S\&RP \& OHR
Measured: 6 months post S&RP
Effects of S&RP & OHR on Homocysteine
Delta log value μmol/L 6 months post S\&RP \& OHR
Measured: 6 months post S&RP
Effects of S&RP & OHR on 8-isoprostane
Delta log value pg/ml 6 months post S\&RP \& OHR
Measured: 6 months post S&RP
Effects of S&RP & OHR on sICAM
Delta log value pg/ml 6 months post S\&RP \& OHR
Measured: 6 months post S&RP
Effects of S&RP & OHR on Apolipoprotein A
Delta log value mg/dL 6 months post S\&RP \& OHR
Measured: 6 months post S&RP
Secondary outcomes (1)
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.
Measured: 6 months post S&RP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start11 Apr 2003
- Primary completion1 Aug 2004
- Study completion4 Jun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Offenbacher, DDS PhD MMsc, Principal investigator, Chair of UNC Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375372
- Sponsor's protocol ID
- 02-1516
- Acronym
- BCU2
- Status last verified
- Nov 2017
- First submitted
- 6 Dec 2017
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Periodontal Therapy on Markers of Acute Phase Response (APR), Oxidative Stress: Phase II {Formerly UNC Biomedical IRB Study # DENT-2019}
- ClinicalTrials.gov ID
- NCT03375372
- Acronym / sponsor ID
- BCU2 / 02-1516
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 11 Apr 2003 (actual)
- Primary completion
- 1 Aug 2004 (actual)
- Study completion
- 4 Jun 2005 (actual)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Treatment Group) | Active comparator | Procedure: 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) |
| 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scaling and Root Planing (S&RP)Also: Scaling & Root Planing (S&RP)dental Scaling and Root Planing and oral hygiene regimen | Procedure or surgery | Group 1 (Treatment Group) |
Primary outcome
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
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
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
Effects of S&RP & OHR on VLDL cholesterol
Time frame: 6 months post S&RP
Delta log value mg/dL post S\&RP \& OHR
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
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
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
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
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
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
1 secondary outcome
Relationship between S&RP and OHR on PGE2 & IL-1beta
Time frame: 6 months post S&RP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Offenbacher, DDS PhD MMsc principal investigator
Chair of UNC Periodontology
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and Root Planing (S&RP) in people with Periodontitis, run by University of North Carolina, Chapel Hill.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of S&RP & OHR on C-Reactive protein (time frame: 6 months post S&RP). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.