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Completed

NCT Number: NCT03074565

Ultrasonic Versus 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Peter C. Fritz, Reconstructive Periodontics and Implant Surgery, Fonthill, Ontario, Canada

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About this study

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surgery is avoided for 93% of patients who undergo sanative therapy at our private periodontal specialty practice (unpublished data).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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasonic alone

Device

Sanative therapy using ultrasonic instrumentation alone

Ultrasonic+

Device

Sanative therapy using ultrasonic plus hand instrumentation

Primary outcomes

  1. Periodontal healing evaluated based on changes in mean probing depth (mm)

    Time frame: Baseline and between 8 and 12 weeks after sanative therapy

    Healing is evaluated based on changes in mean probing depth

Secondary outcomes

  1. 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

  2. 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

  3. 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

Other outcomes

  1. Time spent

    Time frame: Average sanative therapy session is 90 minutes

    Time spent receiving treatment with either modality

  2. Comfort of the experience

    Time frame: Average sanative therapy session is 90 minutes

    The level of comfort experienced by the patient during treatment

  3. Tooth sensitivity

    Time frame: Sanative therapy appointment (90 minutes) and 8 to 12 weeks after sanative therapy

    The level of tooth sensitivity experienced by the patient

Sponsors and collaborators

Lead sponsor

Brock University

Other

Collaborators

  • Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 9, 2017
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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