Clinical Trial: Ultrasonic Versus Ultrasonic+ for Effective Sanative Therapy

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Comparison of Ultrasonic Versus Hand Instrumentation Plus Ultrasonic for Effective Sanative Therapy

Brief Summary: Periodontitis is a chronic oral infection that results in the breakdown of connective tissue and alveolar bone that support the teeth. Non-surgical sanative therapy using a combination treatment of hand and ultrasonic instrumentation is the primary treatment option for patients with periodontitis. However, the hand-held instrumentation requires continuous sharpening for optimal outcomes, which introduces tremendous variability as well as a large increase in time spent by the treating dental hygienists. Therefore, this study aimed to determine if ultrasonic instrumentation alone can provide similar improvements to periodontal outcomes compared to ultrasonic plus hand instrumentation.

Detailed Summary:

Periodontitis is a chronic oral infection that results in the breakdown of connective tissue and alveolar bone that support the teeth. Bacteria and the body's own immune system mediate the severity of periodontitis, where teeth may become loose, fall out or have to be removed. Non-surgical sanative therapy (also referred to as "deep cleaning") is the primary treatment option for patients with generalized chronic periodontitis. This includes debridement with both ultrasonic and hand instrumentation. Using this approach, surgery is avoided for 93% of patients who undergo sanative therapy at our private periodontal specialty practice (unpublished data). However, the hand-held instrumentation requires continuous sharpening for optimal performance, which introduces tremendous variability as well as a large increase in time spent by the hygienists. Ultrasonic instrumentation does not require sharpening, as a new instrument head is used for every new patient.

Therefore, given the interest in "contemporary instrumentation", meaning ultrasonic therapy alone, the primary objective of this study is to determine if similar improvements in periodontal indices can be achieved using ultrasonic instrumentation alone versus ultrasonic instrumentation in conjunction with hand instrumentation.

Secondary objectives included the following: i) to determine if the time required to complete sanative therapy is reduced using ultrasonic therapy alone, given the ultrasonic instruments do not require sharpening and less instrument changes by the hygienist are required during treatment. If the time is less for ultrasonic therapy alone, there is a potential cost-savings for the patient, as well as less time spent receiving therapy in the dental chair; ii) to determine if the treatment with ultrasonic therapy versus ultrasonic therap
Sponsor: Brock University

Current Primary Outcome: Periodontal healing evaluated based on changes in mean probing depth (mm) [ Time Frame: Baseline and between 8 and 12 weeks after sanative therapy ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Plaque index [ Time Frame: Baseline and between 8 and 12 weeks after sanative therapy ]
  O'Leary Plaque Score Index is a score in the total amount of plaque present at 4 surfaces of a tooth
• Bleeding on Probing [ Time Frame: Baseline and between 8 and 12 weeks after sanative therapy ]
  Inflammation is determined by percent of bleeding sites that are measured at 6 sites per tooth
• Clinical Attachment Loss (Periodontal Attachment Loss) [ Time Frame: Baseline and between 8 and 12 weeks after sanative therapy ]
  Periodontal healing is evaluated based on changes in clinical attachment loss

Original Secondary Outcome: Same as current

Information By: Brock University

Dates:
Date Received: March 1, 2017
Date Started: April 1, 2017
Date Completion: June 1, 2018
Last Updated: March 8, 2017
Last Verified: March 2017