- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03452891
Effect of Locally-Applied Simvastatin on Clinical Attachment Level and Alveolar Bone in Periodontal Maintenance Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Dental records of patients attending routine periodontal maintenance therapy visits at the UNMC College of Dentistry clinics are reviewed as part of the direct supervision by faculty, including investigators involved int his study. Assessment includes review of medical and dental histories and previous oral hygiene and periodontal charting. Subjects who appear to qualify (40-85 years old, diagnosis of advanced chronic adult periodontitis, one quadrant with at least 3 posterior teeth and one 6-9 mm periodontal pocket, no systemic diseases or medications which significantly impact periodontal inflammation and bone turnover) will be informed of the study, given an opportunity to ask questions, and given an informed consent form to take home. Once signed consent is obtained, subjects will be randomized to one of the two groups: 1) SRP + SIM or 2) SRP + methylcellulose.
At the baseline visit, all women subjects will be given a urine pregnancy test. Once the pregnancy test is determined to be negative, the following sequence of procedures will be performed by the faculty investigator (AK, RR, RH): 1) assignment of the experimental site (6-9 mm pocket with previous bleeding on probing); 2) remove supraginigval plaque from the experimental tooth with explorer [record positive sites]; 3) insert paper strip into facial and lingual of experimental site sulcus for 30 seconds for gingival crevicular fluid (GCF) sample, remove and place into sterile vial, and freeze at -80º C for testing inflammation markers; 4) measure recession on experimental teeth and adjacent interproximal tooth at mesial-facial, mid-facial, distal-facial, mesial-lingual, mid-lingual and distal lingual with UNC 15 probe; 5) measure probing pocket depths at same surfaces as recession; 6) record sites that bleed within 30 seconds. After the faculty investigator (primary or secondary investigator) leaves, the participating personnel (LK) will; 7) take a baseline radiograph, administer local anesthesia to the experimental site via local injection, 9) surgical mini-flap reflection localized to the experimental site (papilla reflection), 10) remove most of the remaining interproximal soft tissue to allow access to the root and measure markers of inflammation, 11) scaling/root planing of site to remove supra- and subgingival bacterial plaque and calculus; 12) placement of SIM-methylcellulose gel, 13) repositioning of papilla to initial location and placement of intra-oral cyanoacrylate; 14) finish full-mouth measurement of probing depths and bleeding on probing; 15) perform full-mouth scaling to remove supra- and subgingival bacterial plaque and calculus; 16) review oral hygiene instructions.
It is possible that steps 14, 15 and 16 could be completed prior to steps 1-13 on all teeth except experimental and adjacent teeth due to availability of faculty investigators at the time of the PMT appointment.
It is also possible that steps 1-13 could be completed at a separate appointment.
Subjects will return for postoperative visit in two weeks. Subjects will return for subsequent PMT visits after 3, 6, 9 and 12 months. Steps 14-16 will be completed at each visit as part of routine PMT. At 6 and 12 months, steps 2-6 will also be completed. At 12 months, a radiograph will also be taken.
Dental record data that will be recorded at each visit includes probing depths (PD), recession, bleeding on probing (BOP) and presence of plaque (+/-) at test site and adjacent interproximal sites.
The expected amount of time for the baseline visit in 90-120 minutes. The expected amount of time for subsequent visits in 60-90 minutes.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Nebraska
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Lincoln, Nebraska, United States, 68583
- University of Nebraska, College of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age 40-85 years,
- diagnosis of chronic advanced adult periodontitis,
- one quadrant with at least one 6-9 mm interproximal pocket,
- overall good systemic health,
- willingness to sign consent form.
Exclusion Criteria:
- systemic diseases which significantly impact periodontal inflammation and bone turnover (e.g. rheumatoid arthritis),
- taking drugs which significantly impact periodontal inflammation and bone turnover (e.g. chronic use of steroids or non-steroidal anti-inflammatory drug (>325 mg/d), estrogens, bisphosphonates, calcitonin, methotrexate),
- surgical periodontal therapy within the past year,
- pregnant or breast-feeding females.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Simvastatin Methylcellulose
simvastatin in methylcellulose gel
|
Simvastatin-Methylcellulose gel will be placed in a deep (6-9 mm) periodontal pocket.
Other Names:
|
Placebo Comparator: Methylcellulose Gel
Methylcellulose gel
|
Methylcellulose gel will be placed in a deep (6-9 mm) periodontal pocket.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Clinical Attachment Level (CAL)
Time Frame: The CAL will be measured at 12-months.
|
The change in CAL will be measured and calculated by measuring recession and subtracting the periodontal probing depth.
|
The CAL will be measured at 12-months.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amy C Killeen, DDS, MS, University of Nebraska Medical Center College of Dentistry
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0217-18-FB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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