Clinical trial NCT03074565: Ultrasonic Versus Ultrasonic+ for Effective Sanative Therapy
Official title: Comparison of Ultrasonic Versus Hand Instrumentation Plus Ultrasonic for Effective Sanative Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Periodontal Pocket
Keywords: Sanative Therapy
Ultrasonic Therapy
Deep Scaling
Hand Scaling
Lead sponsor: Brock University
Sponsor class: OTHER
Collaborators: name: Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
First posted: 2017-03-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects will be randomized to receive one of two treatment modalities on either the left or right side of the mouth on their first treatment visit. During the second treatment visit, subjects will receive the other treatment modality on the other side of the mouth.
Primary purpose: HEALTH_SERVICES_RESEARCH

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 description: 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surgery is avoided for 93% of patients who undergo sanative therapy at our private periodontal specialty practice (unpublished data).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 therapy and hand instrumentation is more comfortable for the patient; and iii) to determine if there is less sensitivity to the teeth with ultrasonic therapy alone compared to the combination of ultrasonic therapy and hand instrumentation.

Eligibility criteria: Inclusion Criteria:

* Both males and females age 19 years or older who are undergoing sanative therapy for moderate to severe chronic periodontitis are eligible.
* Chronic periodontitis has been classified as localized or generalized depending on whether \<30% or \>30% of sites are involved.
* Severity is based on the amount of clinical attachment loss (CAL) and is designated as slight (1-2 mm CAL), moderate (3-4 mm CAL) or severe (\> 5 mm CAL).

Exclusion Criteria:

* Patients with dental implants,
* pregnancy,
* a recent history of antibiotic use (within 3 months prior to treatment) and
* inability to give consent for the study.

Primary outcomes:
measure: Periodontal healing evaluated based on changes in mean probing depth (mm)
timeFrame: Baseline and between 8 and 12 weeks after sanative therapy
Secondary outcomes:
measure: Plaque index
timeFrame: Baseline and between 8 and 12 weeks after sanative therapy
measure: Bleeding on Probing
timeFrame: Baseline and between 8 and 12 weeks after sanative therapy
measure: Clinical Attachment Loss (Periodontal Attachment Loss)
timeFrame: Baseline and between 8 and 12 weeks after sanative therapy
Other outcomes:
measure: Time spent
timeFrame: Average sanative therapy session is 90 minutes
measure: Comfort of the experience
timeFrame: Average sanative therapy session is 90 minutes
measure: Tooth sensitivity
timeFrame: Sanative therapy appointment (90 minutes) and 8 to 12 weeks after sanative therapy
Locations:
city: Fonthill
country: Canada
facility: Dr. Peter C. Fritz, Reconstructive Periodontics and Implant Surgery
state: Ontario
city: St. Catharines
country: Canada
facility: Brock University
state: Ontario
Study officials:
affiliation: Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
name: Peter C Fritz, D.D.S.
role: STUDY_DIRECTOR
References: