Ultrasonic Versus Ultrasonic+ for Effective Sanative Therapy

NCT03074565 | Completed

• 1 other identifier: 16-224
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Periodontitis; Periodontal Pocket

Keywords

Sanative Therapy; Ultrasonic Therapy; Deep Scaling; Hand Scaling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Plaque index

  Baseline and between 8 and 12 weeks after sanative therapy

• Bleeding on Probing

  Baseline and between 8 and 12 weeks after sanative therapy

• Clinical Attachment Loss (Periodontal Attachment Loss)

  Baseline and between 8 and 12 weeks after sanative therapy

Other Outcomes (3)

• Time spent

  Average sanative therapy session is 90 minutes

• Comfort of the experience

  Average sanative therapy session is 90 minutes

• Tooth sensitivity

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

Study Arms (2)

Ultrasonic alone

EXPERIMENTAL

Sanative therapy using ultrasonic instrumentation only.

Device: Ultrasonic alone

Ultrasonic+

ACTIVE COMPARATOR

Sanative therapy using ultrasonic plus hand instrumentation.

Device: Ultrasonic+

Interventions

Ultrasonic alone DEVICE

Sanative therapy using ultrasonic instrumentation alone

Ultrasonic alone

Ultrasonic+ DEVICE

Sanative therapy using ultrasonic plus hand instrumentation

Ultrasonic+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brock University: lead
• Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery: collaborator

Study Sites (2)

Dr. Peter C. Fritz, Reconstructive Periodontics and Implant Surgery

Fonthill, Ontario, L0S1E5, Canada

Location

Brock University

St. Catharines, Ontario, L2S3A1, Canada

Location

MeSH Terms

Conditions

Periodontitis; Periodontal Pocket

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Peter C Fritz, D.D.S.

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: An investigator, not involved in providing the treatment, will be responsible for randomizing each subject to an initial treatment modality and to which side of the mouth they will receive each treatment. The patient will be masked as to which modality has been used. The care provider cannot be masked as they must use different instrumentation for each treatment type. When assessing outcomes, the investigator will be masked as to the treatment modality and the side of the mouth.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 9, 2017
• Study Start: May 1, 2017
• Primary Completion: February 5, 2019
• Study Completion: February 5, 2019
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)