Effect of Locally-Applied Simvastatin on Clinical Attachment Level and Alveolar Bone in Periodontal Maintenance Patients

NCT03452891 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 0217-18-FB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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 methylcellulose gel alone. 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.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Attachment Level (CAL)

  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.

Study Arms (2)

Simvastatin Methylcellulose

EXPERIMENTAL

simvastatin in methylcellulose gel

Drug: Simvastatin-Methylcellulose

Methylcellulose Gel

PLACEBO COMPARATOR

Methylcellulose gel

Other: Methylcellulose

Interventions

Methylcellulose OTHER

Methylcellulose gel will be placed in a deep (6-9 mm) periodontal pocket.

Methylcellulose Gel

Simvastatin-Methylcellulose DRUG

Simvastatin-Methylcellulose gel will be placed in a deep (6-9 mm) periodontal pocket.

Also known as: Simvastatin

Simvastatin Methylcellulose

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska, College of Dentistry

Lincoln, Nebraska, 68583, United States

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Methylcellulose; Simvastatin

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Cellulose; Glucans; Polysaccharides; Carbohydrates; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Amy C Killeen
• Organization: University of Nebraska Medical Center

akilleen@unmc.edu

402-479-6205

Study Officials

• Amy C Killeen, DDS, MS

  University of Nebraska Medical Center College of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 2, 2018
• Study Start: March 1, 2019
• Primary Completion: July 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 5, 2023
• Results First Posted: February 9, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)