Effect of Locally-Applied Simvastatin on Clinical Attachment Level and Alveolar Bone in Periodontal Maintenance Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 40 - 85 |
| Updated: | 3/6/2019 |
| Start Date: | March 1, 2019 |
| End Date: | July 1, 2021 |
| Contact: | Amy C Killeen, DDS, MS |
| Email: | akilleen@unmc.edu |
| Phone: | 402-472-7848 |
The purpose of this study is to determine of local application of commericially-available,
FDA-approved preparation of simvastatin is effective in increasing clinical attachment levels
(primary outcome), as well as alveolar bone (secondary outcome) compared to standard
mechanical therapy in patients on periodontal maintenance therapy (PMT). Subjects undergoing
PMT at the UNMC College of Dentistry clinics will be recruited to participate in the
randomized one-year clinical trial based on the following eligibility criteria: 1) diagnosis
of chronic advanced periodontitis (generalized or localized), 2) participating in regular PMT
visits (3-6) month intervals), 3) no systemic diseases or medication which significantly
impact periodontal inflammation or bone turnover (e.g. steroids, bisphosphonates, > 325 mg
aspirin/day and in good general health, 4) one experimental quadrant of the mouth with an
inflamed 6-9 mm interproximal posterior periodontal pocket with history of bleeding on
probing (BOP), 5) willingness to sign consent form. Subjects will be divided into two groups
for additional therapy in a 6-9 mm interproximal periodontal pocket at baseline: 1) local
anesthesia and mini-flap reflection with subgingival mechanical debridement plus application
of the simvastatin-methylcellulose gel or 2) local anesthesia and mini-flap reflection with
subgingival mechanical debridement plus application of saline. Samples/measurement will be
obtained at the designated experimental site at baseline, 2 weeks, 6 and 12 months during
PMT: 1) digital radiographs (baseline and 12 months only; bone height measurements), 2)
presence of explorer-detectable supragingival plaque, 3) 30-second gingival crevicular fluid
(GCF) sample (markers of inflammation, bone turnover), 4) recession from the cemento-enamel
junction, 5) probing pocket depth and bleeding on probing (BOP). Following the 12-month
visit, the research-specific intervention and measurements in the experiment quadrant will be
removed from routine PMT.
FDA-approved preparation of simvastatin is effective in increasing clinical attachment levels
(primary outcome), as well as alveolar bone (secondary outcome) compared to standard
mechanical therapy in patients on periodontal maintenance therapy (PMT). Subjects undergoing
PMT at the UNMC College of Dentistry clinics will be recruited to participate in the
randomized one-year clinical trial based on the following eligibility criteria: 1) diagnosis
of chronic advanced periodontitis (generalized or localized), 2) participating in regular PMT
visits (3-6) month intervals), 3) no systemic diseases or medication which significantly
impact periodontal inflammation or bone turnover (e.g. steroids, bisphosphonates, > 325 mg
aspirin/day and in good general health, 4) one experimental quadrant of the mouth with an
inflamed 6-9 mm interproximal posterior periodontal pocket with history of bleeding on
probing (BOP), 5) willingness to sign consent form. Subjects will be divided into two groups
for additional therapy in a 6-9 mm interproximal periodontal pocket at baseline: 1) local
anesthesia and mini-flap reflection with subgingival mechanical debridement plus application
of the simvastatin-methylcellulose gel or 2) local anesthesia and mini-flap reflection with
subgingival mechanical debridement plus application of saline. Samples/measurement will be
obtained at the designated experimental site at baseline, 2 weeks, 6 and 12 months during
PMT: 1) digital radiographs (baseline and 12 months only; bone height measurements), 2)
presence of explorer-detectable supragingival plaque, 3) 30-second gingival crevicular fluid
(GCF) sample (markers of inflammation, bone turnover), 4) recession from the cemento-enamel
junction, 5) probing pocket depth and bleeding on probing (BOP). Following the 12-month
visit, the research-specific intervention and measurements in the experiment quadrant will be
removed from routine PMT.
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.
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.
Inclusion Criteria:
1. age 40-85 years,
2. diagnosis of chronic advanced adult periodontitis,
3. one quadrant with at least one 6-9 mm interproximal pocket,
4. overall good systemic health,
5. willingness to sign consent form.
Exclusion Criteria:
1. systemic diseases which significantly impact periodontal inflammation and bone
turnover (e.g. rheumatoid arthritis),
2. 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),
3. surgical periodontal therapy within the past year,
4. pregnant or breast-feeding females.
We found this trial at
1
site
Lincoln, Nebraska 68583
Principal Investigator: Amy C Killeen, DDS, MS
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