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

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.

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