Ultrasonic Versus Ultrasonic+ for Effective Sanative Therapy

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03074565
• Other study ID #: 16-224
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: February 5, 2019

Study information

• Verified date: July 2019
• Source: Brock University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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surgery is avoided for 93% of patients who undergo sanative therapy at our private periodontal specialty practice (unpublished data).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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 5, 2019
• Est. primary completion date: February 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Pocket
• Periodontitis

Intervention

Device:
• Ultrasonic alone
Sanative therapy using ultrasonic instrumentation alone
• Ultrasonic+
Sanative therapy using ultrasonic plus hand instrumentation

Locations

Country	Name	City	State
Canada	Dr. Peter C. Fritz, Reconstructive Periodontics and Implant Surgery	Fonthill	Ontario
Canada	Brock University	St. Catharines	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Brock University	Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery

Country where clinical trial is conducted

Canada, 

Outcome

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