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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

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.

Condition or disease Intervention/treatment Phase
Periodontal Diseases Dental Diseases Procedure: Scaling and root planing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Instrumentation Effectiveness of Modified, Area-Specific Hand Scalers During Non-Surgical Periodontal Therapy on Teeth Presenting With Moderate to Advanced Periodontitis
Actual Study Start Date : November 9, 2018
Actual Primary Completion Date : June 17, 2019
Actual Study Completion Date : June 17, 2019

Arm Intervention/treatment
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.
Procedure: Scaling and root planing
Non-surgical instrumentation will be performed with specific instruments prior to treatment planned extraction by another provider.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729167


Locations
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United States, Michigan
University of Michigan School of Dentistry
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
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Responsible Party: Danielle Furgeson, Director, Graduate Dental Hygiene Program, University of Michigan
ClinicalTrials.gov Identifier: NCT03729167    
Other Study ID Numbers: HUM00145158
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Danielle Furgeson, University of Michigan:
periodontal debridement
non-surgical therapy
periodontal disease
dental scaling
Additional relevant MeSH terms:
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Periodontal Diseases
Stomatognathic Diseases
Mouth Diseases