Clinical Research Directory

Comparison of Two Non-surgical Procedure to Manage Gum Disease Around Implants.

Sponsor: King's College London

Summary

Research Question: Can a minimally invasive, non-surgical treatment approach (MINST) be more effective than the current standard non-surgical method in treating peri-implantitis, a common inflammatory condition affecting dental implants? Background: Dental implants are widely used to replace missing teeth. While they are usually successful, some patients develop a condition called peri-implantitis, an infection that causes inflammation and bone loss around the implant. This can eventually lead to implant failure if not treated properly. Currently, non-surgical treatments are used to clean the area and reduce inflammation. However, these methods often fall short of fully resolving the issue, and many patients require further treatment or even surgery. A newer approach called MINST (Minimally-Invasive Non-Surgical Therapy) has shown promising results for treating gum disease around natural teeth. This method focuses on precision cleaning with minimal trauma to the surrounding tissues, reducing pain and improving healing. While MINST works well for gum disease, its effectiveness for treating peri-implantitis has not yet been tested. Purpose of the Study: This clinical trial will compare the effectiveness of MINST with the standard non-surgical treatment currently used for peri-implantitis. The aim is to determine whether MINST can better treat the disease, improve healing, and reduce discomfort for patients. Hypotheses: Alternate Hypothesis (What we expect to find): MINST will result in better outcomes, specifically, fewer deep pockets around the implant, less bleeding, and fewer signs of infection, compared to the standard treatment. Null Hypothesis: There will be no significant difference between the outcomes of the two treatment approaches. Study Design: Type of Study: A randomized controlled trial (RCT) involving 106 patients. Duration: Patients will be followed for 12 months after treatment. Locations: Multiple dental centers participating in the trial. Method: Half of the participants will receive MINST; the other half will receive the standard treatment. Neither patients nor outcome assessors will know which treatment was used (single-masked). What Will Be Measured? Primary Goal: To see how many patients show healing (defined as smaller pockets, little or no bleeding, and no pus) 12 months after treatment. Secondary Goals: Patient-reported outcomes, including pain levels and quality of life Changes in pocket depth and tissue attachment Bacterial changes Time taken for treatment appointments Why Is This Important? If MINST proves to be more effective and comfortable for patients, it could change how peri-implantitis is managed in the future- potentially reducing the need for surgery, improving patient experience, and helping more people keep their dental implants for longer.

Official title: Minimally-Invasive Non-Surgical Therapy Of Peri-implantitis: A Multicenter Randomized Controlled Trial

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