Arestin + SRP for Gum Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how Arestin, an antibiotic, can aid individuals with both diabetes and gum disease when added to standard gum disease cleaning. The researchers aim to determine if Arestin can improve gum health, help control blood sugar levels, and reduce overall body inflammation. Participants will receive either the standard cleaning or the cleaning plus Arestin. This trial suits individuals with type 2 diabetes who haven't had recent gum treatments and have significant gum disease. As an Early Phase 1 trial, this research focuses on understanding Arestin's effects in people, offering participants the opportunity to be among the first to receive this treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you have used antibiotics in the past 3 months, you cannot participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Arestin, which contains tiny particles of the antibiotic minocycline, is generally safe for gum disease treatment. One study found that using Arestin with deep cleaning of the teeth and gums (scaling and root planing, or SRP) is both safe and effective. No major safety issues arose when used for gum disease, but it is not recommended for individuals with oral candidiasis, a yeast infection in the mouth.
This treatment remains in the early testing stages for this specific use, so researchers are collecting more detailed safety information. However, Arestin is already approved for treating gum disease, indicating it has passed safety checks for this condition in general. Although rare, some individuals might experience side effects, such as irritation at the application site.
Overall, current studies suggest that Arestin is safe for treating gum disease, especially when combined with traditional cleaning methods like SRP.12345Why do researchers think this study treatment might be promising?
Arestin is unique because it uses minocycline microspheres to deliver antibiotics directly into the gum pockets affected by gum disease. Unlike traditional treatments that rely solely on scaling and root planing to clean the gums, Arestin provides a targeted antibiotic approach that can enhance healing. Researchers are excited about Arestin because its localized delivery method allows for a high concentration of the antibiotic right where it's needed, potentially leading to more effective and faster results in reducing gum disease symptoms compared to standard care alone.
What evidence suggests that Arestin might be an effective treatment for gum disease?
This trial will compare the effectiveness of adding Arestin to scaling and root planing (SRP) against SRP alone for treating gum disease. Research has shown that adding Arestin to SRP can improve gum health. In one study, patients who received both SRP and Arestin experienced a greater reduction in the space between their gums and teeth compared to those who only had SRP. Arestin contains minocycline, which fights bacteria over time and aids in gum healing. Another study found that Arestin was more effective at reducing harmful bacteria in the mouth. These findings suggest that Arestin could enhance gum disease treatments, especially for people with diabetes.13567
Who Is on the Research Team?
Gian Pietro Schincaglia, DDS, PhD
Principal Investigator
Case Western Reserve University
Are You a Good Fit for This Trial?
This trial is for individuals with Type 2 Diabetes who also have gum disease. Participants should not have Cyclopia, a rare eye condition. The study seeks to understand how well they respond to a dental treatment that includes a local antibiotic alongside standard cleaning procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive scaling and root planing with or without Arestin (minocycline microspheres)
Follow-up
Participants are monitored for periodontal pocket closure, glycemic control, and systemic inflammation
What Are the Treatments Tested in This Trial?
Interventions
- Arestin
Trial Overview
The trial tests the effectiveness of Arestin (minocycline microspheres) when used with Scaling and Root Planing (SRP), which is a deep cleaning procedure for gums. It measures improvements in gum health, blood sugar levels, and overall inflammation in diabetic patients.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Minocycline microspheres (Arestin®) / (4 mg per cartridge) prefilled delivery syringe / Arestin will be placed in the pocket only one time after scaling and root planing.
Scaling and Root Planing Alone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Case Western Reserve University
Lead Sponsor
OraPharma
Industry Sponsor
Citations
ARESTIN | Clinical Efficacy
“After 1 month of treatment, patients receiving SRP plus minocycline microspheres had a significantly greater mean reduction in PD when compared with vehicle ...
Enhancing the value of scaling and root-planing: Arestin ...
This paper evaluates the efficacy of the minocycline microspheres in patients with moderate to severe periodontitis in a model, which is a randomised ...
New Clinical Study Suggests the Use of OraPharma's ...
This study identified that the administration of minocycline HCI microspheres, 1mg did significantly decrease specific periodontal pathogens.
Gum disease is caused by bacteria.1 Fight infection by ...
The microspheres release antibiotic over time, fighting bacteria and reducing pocket depth, to help your gums heal better than with SRP alone. The benefits of a ...
ARESTIN® (minocycline hydrochloride) Microspheres, 1 mg
The safety and effectiveness of ARESTIN® has not been established for the treatment of periodontitis in patients with coexistent oral candidiasis. ARESTIN ...
Effect of a controlled release device containing minocycline ...
The results of this study clearly indicate that treatment with scaling and root planing plus minocycline microspheres (Arestin™) is more effective and safer ...
Long-term Safety of Minocycline in Patients With Gum ...
The objective of this study is to evaluate the changes in populations of minocycline-resistant bacteria after long-term use of minocycline HCl ...
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