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Instrumentation Effectiveness of Modified, Area-Specific Hand Scalers During Non-Surgical Periodontal Therapy

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ClinicalTrials.gov Identifier: NCT03729167
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Danielle Furgeson, University of Michigan

Tracking Information
First Submitted Date  ICMJE October 31, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date June 18, 2019
Actual Study Start Date  ICMJE November 9, 2018
Actual Primary Completion Date June 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2018)
Modified, Area Specific hand scalers in 5mm or greater pockets [ Time Frame: Day 1 ]
Amount of remaining deposits after instrumentation with the various curettes depending on which group the subject is randomized into on 5mm pockets or greater.
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
Standard Curettes [ Time Frame: Day 1 ]
Amount of remaining deposits after instrumentation with the various curettes depending on which group the subject is randomized into.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2018)
Modified, Area Specific hand scalers in 5mm to 7mm pockets [ Time Frame: Day 1 ]
Amount of remaining deposits after instrumentation with the various curettes depending on which group the subject is randomized into on 5mm to 7mm pockets.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Instrumentation Effectiveness of Modified, Area-Specific Hand Scalers During Non-Surgical Periodontal Therapy
Official Title  ICMJE Instrumentation Effectiveness of Modified, Area-Specific Hand Scalers During Non-Surgical Periodontal Therapy on Teeth Presenting With Moderate to Advanced Periodontitis
Brief Summary The goal of this project is to analyze the effectiveness of calculus and biofilm removal using area-specific hand scalers such as Mini Five® Gracey Curettes and Micro Mini Five® Gracey Curettes in periodontal pockets that are 5mm or greater. The data collected from this project will provide the evidence needed to support the use of modified hand scalers during non-surgical periodontal therapy for clinicians.
Detailed Description

Patient selection for this prospective study will be done using a specific inclusion and exclusion criteria listed in the Protocol Registration. In order to recruit participants for this study, scheduled surgeries will be reviewed for possible patient selection meeting the criteria for patient's having extractions of multi-rooted posterior teeth. Patients who are scheduled for the specified extractions will be recruited by mail. Patients who are interested in participating in the study will be able to contact Graduate Periodontics to express their interest in the study and schedule informed consent appointment. Participants wishing to take part in the study will receive informed consent and will have any questions answered for them. At the informed consent appointment, participants will be evaluated using the inclusion/exclusion criteria and will be chosen based on the findings.

After the informed consent appointment, eligible participants will return for the clinical study and their surgical extraction. A complete review of the medical history will be completed, including blood pressure and heart rate recordings. Baseline measurements such as plaque index score (PI), bleeding on probing (BOP), probing depths (PD), clinical attachment loss (CAL), and gingival recession (GR) will all be completed. All measurement will be done using a University of North Carolina periodontal probe (UNC) with 1mm markings. Measurements will also be taken according to the number of roots and locations of furcation for teeth that meet the inclusion criteria. All measurements will be performed by one calibrated examiner and intra-examiner calibration will be performed at two time points: pre-study and intra-study. Periapical and bitewing radiographs will only be taken if not done within the last 6 months.

After meeting the criteria for the study and following informed consent from the patient, the participant will be prepped for scaling and root planing of the specified teeth. Local anesthesia will be administered for patient comfort in the surrounding area of the specified tooth (teeth).

Teeth will be randomly assigned to one of three groups for the study: the first group is the control group and will have scaling and root planing completed using area-specific standard Gracey curettes. The second group will have scaling and root planing completed using area-specific modified Gracey curettes, and the final group will have scaling and root planing completed using the Piezo Ultrasonic scaler for calculus and biofilm removal. Area-specific standard and modified Gracey curette types include: anterior scalers 1/2, and posterior scalers 11/12 and 13/14. Hand instrumentation will occur until the root surfaces feel smooth using tactile sensitivity with an ODU 11/12 explorer.

Following completion of scaling and root planing, the tooth will be prepared for extraction by the clinician who treatment planned its extraction. A surgical informed consent will be signed by the patient prior to the extraction and additional local anesthesia will be administered if necessary. The surgeon will mark the gingival margin level on the tooth using a ½ round bur and extract the tooth without damaging the root surfaces. The surgeon who performed the extraction for the participant will tend to the post-operative needs of the individual while the tooth that was extracted for the study will be rinsed with running water to remove any blood or soft tissue that may remain on the root surfaces for 1-2 minutes. The tooth will then be transferred to 1% methylene blue solution for staining for 2 minutes, then rinsed again with water for 2-3 minutes. The extracted specimen will be placed in a primary containment vile, which then will be placed in a clean labelled biohazard bag for secondary containment for being transferred to the lab where evaluation of the root surfaces will occur.

The root surfaces of the tooth will be evaluated using a Nikon SMZ 745T stereomicroscope at 10 times the magnification for any residual biofilm or calculus. Image J software will be used to scale and measure residual biofilm and calculus and then calculations will be made to determine the percentage of what remain on the root surfaces will be calculated to assess the efficiency of modified, area-specific hand scalers. Clinical photos of the stained tooth will also be taken for further documentation of any residual presence of calculus.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Periodontal Diseases
  • Dental Diseases
Intervention  ICMJE Procedure: Scaling and root planing
Non-surgical instrumentation will be performed with specific instruments prior to treatment planned extraction by another provider.
Study Arms  ICMJE Experimental: Scaling and root planing
Teeth that have been given a prognosis of hopeless and treatment planned for extraction will be scaled and root planed with various non-surgical instruments prior to extraction. The teeth will then be photographed and assessed for remaining hard accretion deposits to determine the effectiveness of the instruments.
Intervention: Procedure: Scaling and root planing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2019)
12
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2018)
27
Actual Study Completion Date  ICMJE June 17, 2019
Actual Primary Completion Date June 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy patients
  • Patients 18 years old or considered an adult in the state in which they live
  • Well-controlled systemic conditions
  • Diagnosis of localized or generalized moderate to advanced periodontitis
  • 1 or more multi-rooted, posterior teeth planned for extraction

    • Clinical attachment loss of 3-4 mm
    • Probing depths greater than 4 mm

Exclusion Criteria:

  • Patients taking anti-coagulants except for low-dose aspirin
  • Patients with significant cardiac conditions that would limit the amount of local anesthetic administered during any one dental visit
  • Third molars
  • Root caries that would interfere with a simple extraction
  • Damaged root surfaces
  • External root resorption
  • Previously endodontic treated teeth with a current periapical lesion present
  • Teeth that break during the extraction
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03729167
Other Study ID Numbers  ICMJE HUM00145158
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Danielle Furgeson, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Michigan
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP