Ultrasonic Versus Ultrasonic+ for Effective Sanative Therapy

Study Overview
=================
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surgery is avoided for 93% of patients who undergo sanative therapy at our private periodontal specialty practice (unpublished data).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.

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

Conditions
-----------------
Periodontitis, Periodontal Pocket

Intervention / Treatment
-----------------
* Device: Ultrasonic alone
* Device: Ultrasonic+


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasonic alone<br>Sanative therapy using ultrasonic instrumentation only. | Device: Ultrasonic alone<br>* Sanative therapy using ultrasonic instrumentation alone<br>|
| Active Comparator: Ultrasonic+<br>Sanative therapy using ultrasonic plus hand instrumentation. | Device: Ultrasonic+<br>* Sanative therapy using ultrasonic plus hand instrumentation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal healing evaluated based on changes in mean probing depth (mm) | Healing is evaluated based on changes in mean probing depth | Baseline and between 8 and 12 weeks after sanative therapy | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sanative Therapy, Ultrasonic Therapy, Deep Scaling, Hand Scaling