Periodontal DiseasesNCT03729167
Instrumentation Effectiveness of Modified, Area-Specific Hand Scalers During Non-Surgical Periodontal Therapy
A study testing Scaling and root planing in people with Periodontal Diseases and Dental Diseases, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Dental Diseases
- What is being tested?
- Scaling and root planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2018to 17 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109
About this study
Official title: Instrumentation Effectiveness of Modified, Area-Specific Hand Scalers During Non-Surgical Periodontal Therapy on Teeth Presenting With Moderate to Advanced Periodontitis
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.
Read the 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.
- Conditions
- Periodontal Diseases, Dental Diseases
- Being tested
- Scaling and root planing
- Keywords
- periodontal debridement, non-surgical therapy, periodontal disease, dental scaling
- Medical subject headings
- Periodontal Diseases, Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planingProcedure or surgery
Non-surgical instrumentation will be performed with specific instruments prior to treatment planned extraction by another provider.
| Study group | Role | What they receive |
|---|---|---|
| Scaling and root planing | Experimental | 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. Receives: Procedure: Scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (1)
Modified, Area Specific hand scalers in 5mm to 7mm pockets
Amount of remaining deposits after instrumentation with the various curettes depending on which group the subject is randomized into on 5mm to 7mm pockets.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start9 Nov 2018
- Primary completion17 Jun 2019
- Study completion17 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle Furgeson, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729167
- Sponsor's protocol ID
- HUM00145158
- Status last verified
- Jun 2019
- First submitted
- 31 Oct 2018
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instrumentation Effectiveness of Modified, Area-Specific Hand Scalers During Non-Surgical Periodontal Therapy on Teeth Presenting With Moderate to Advanced Periodontitis
- ClinicalTrials.gov ID
- NCT03729167
- Acronym / sponsor ID
- HUM00145158
- Conditions
- Periodontal Diseases, Dental Diseases
- Keywords
- periodontal debridement, non-surgical therapy, periodontal disease, dental scaling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 17 Jun 2019 (actual)
- Study completion
- 17 Jun 2019 (actual)
- First posted
- 2 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scaling and root planing | Experimental | Procedure: Scaling and root planingTeeth 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scaling and root planingNon-surgical instrumentation will be performed with specific instruments prior to treatment planned extraction by another provider. | Procedure or surgery | Scaling and root planing |
Primary outcome
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.
1 secondary outcome
Modified, Area Specific hand scalers in 5mm to 7mm pockets
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and root planing in people with Periodontal Diseases and Dental Diseases, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified, Area Specific hand scalers in 5mm or greater pockets (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.