Instrumentation Effectiveness of Modified, Area-Specific Hand Scalers During Non-Surgical Periodontal Therapy
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2018
CompletedFirst Posted
Study publicly available on registry
November 2, 2018
CompletedStudy Start
First participant enrolled
November 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2019
CompletedJune 18, 2019
June 1, 2019
7 months
October 31, 2018
June 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Modified, Area Specific hand scalers in 5mm or greater pockets
Amount of remaining deposits after instrumentation with the various curettes depending on which group the subject is randomized into on 5mm pockets or greater.
Day 1
Secondary Outcomes (1)
Modified, Area Specific hand scalers in 5mm to 7mm pockets
Day 1
Study Arms (1)
Scaling and root planing
EXPERIMENTALTeeth 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.
Interventions
Non-surgical instrumentation will be performed with specific instruments prior to treatment planned extraction by another provider.
Eligibility Criteria
You may qualify if:
- 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
- or more multi-rooted, posterior teeth planned for extraction
- Clinical attachment loss of 3-4 mm
- Probing depths greater than 4 mm
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Graduate Dental Hygiene Program
Study Record Dates
First Submitted
October 31, 2018
First Posted
November 2, 2018
Study Start
November 9, 2018
Primary Completion
June 17, 2019
Study Completion
June 17, 2019
Last Updated
June 18, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share