Ultrasonic Versus Ultrasonic+ for Effective Sanative Therapy

Comparison of Ultrasonic Versus Hand Instrumentation Plus Ultrasonic for Effective Sanative Therapy

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Periodontal Pocket
• Intervention / Treatment: Device: Ultrasonic alone; Device: Ultrasonic+

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surgery is avoided for 93% of patients who undergo sanative therapy at our private periodontal specialty practice (unpublished data).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

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Fonthill, Ontario, Canada, L0S1E5
      • Dr. Peter C. Fritz, Reconstructive Periodontics and Implant Surgery
    • St. Catharines, Ontario, Canada, L2S3A1
      • Brock University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasonic alone; Sanative therapy using ultrasonic instrumentation only.	Device: Ultrasonic alone; Sanative therapy using ultrasonic instrumentation alone
Active Comparator: Ultrasonic+; Sanative therapy using ultrasonic plus hand instrumentation.	Device: Ultrasonic+; Sanative therapy using ultrasonic plus hand instrumentation

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time spent	Time spent receiving treatment with either modality	Average sanative therapy session is 90 minutes
Comfort of the experience	The level of comfort experienced by the patient during treatment	Average sanative therapy session is 90 minutes
Tooth sensitivity	The level of tooth sensitivity experienced by the patient	Sanative therapy appointment (90 minutes) and 8 to 12 weeks after sanative therapy

Collaborators and Investigators

• Sponsor: Brock University
• Collaborators: Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
• Investigators: Study Director: Peter C Fritz, D.D.S., Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): February 5, 2019
• Study Completion (Actual): February 5, 2019

Study Registration Dates

• First Submitted: March 1, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (Actual): March 9, 2017

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Ultrasonic Therapy; Sanative Therapy; Deep Scaling; Hand Scaling
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Periodontal Pocket
• Other Study ID Numbers: 16-224

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No