Relate Post-endodontic Pain Clinical Trial
Official title:
Use of Intracanal Cryotherapy on Post-endodontic Pain After Single-visit RCT Using Manual and Reciprocating Systems When Apical Patency is Conserved.
The goal of this research was to relate the occurrence of post-endodontic pain after single-visit RCT using Balanced Force technique and three reciprocating system when AP is conserved. Methodology: All 224 patients had upper or lower molar, premolar or anterior teeth selected for conventional RCT for prosthetic reasons detected with only vital pulps. Of the sample of 224 teeth, 56 were selected to the 4 instrumentation methods. For hand instrumentation, Balanced Force were used. All canals were clean and shaped with hand Flex-R files (fMoyco/Union Broach, York PA, USA). For mechanical shaping, all instruments were used with a micro motor (VDW, Munich Germany). Twisted files adaptive, WaveOne and Reciproc instruments. Final irrigation with cold (6oC) 17% EDTA served as a lubricant.
This clinical research took place at the University Autonomous of Baja California, School of
Dentistry, Tijuana, Mexico. The subjects review committee accepted the research, and
conducted in accordance with ethical principles (including the World Medical Association
Declaration of Helsinki).
The principal inclusion parameters were absence of radiographic sign of apical periodontitis
and a diagnosis of irreversible pulpitis (IP) established by affirmative response to hot and
cold examinations.
Thermal pulp examination was achieved by the corresponding author, and radiographic analysis
was established by 3 certified endodontists. Clinical requirements were established on the
next conditions: 1) The purposes and necessities of the research were spontaneously accepted.
2) Clinical Management was pointed to patients in physical and mental well-being. 3) All
teeth had vital pulps and absence of apical periodontitis. 4) Positive thermal stimulation
with EndoIce (Hygenic Corp, Akron, OH). 5) Teeth with enough coronal structure for rubber dam
isolation. 6) No RCT done before the research. 7) No painkillers or antibiotics used 7 days'
prior the clinical events started.
Exclusion parameters were the necessity for retreatment, gravidity, impossibility to obtain
patient's approval, patients who didn't complete inclusion necessities, a history of
medication for chronic pain or those compromising the immune response, patients younger than
18 years and the existence of mishaps or difficulties during RCT (calcified canals,
impracticality of achieving AP in any canal).
Patient selection Two hundred and twenty four of 245 patients (126 women and 98 men) aged
18-65 years were incorporated in this research (Fig. 1). Sample size estimate was achieved
according with a method for this specific purpose (Cochran's method, 1986). Therefore, the 56
teeth allocated to each group were adequate to confirm an essential sample.
Random Selection of instrumentation groups. Of the sample of 224 teeth, 56 were selected to
the 4 instrumentation methods. The study strategy included 3 experts; each expert prepared 56
teeth, 14 per technique.
Treatment Protocol The standard method involved the following steps: Access was gotten; REDTA
(Roth International, Chicago, IL) lubricant was located at the entry of the canals.
Determination of WL was first determined with a #15 k-file and the Root ZX electronic device
(J Morita, Irvine CA, USA), following by subtracting 0.5 mm from the measurement, which was
calculated with the assistance of a metallic ruler. With digital radiographic confirmation
(Schick Technologies, NY, USA). A glide path to the WL was then established.
For hand instrumentation, Balanced Force were used. All canals were clean and shaped with
hand Flex-R files (fMoyco/Union Broach, York PA, USA). Gates-Glidden burs (Dentsply
Maillefer) sizes #2 and #3 were used at the entry of the canals. For mechanical shaping, all
instruments were used with a micro motor (VDW Silver Reciproc Motor). Torque and rotation
were established independently for each instrument method used. Twisted file adaptive,
WaveOne and Reciproc instruments were used in continuous brushing rotary motion and
reciprocating mode respectively.
Group TFA. SM1 (size 20, .04 taper) and SM2 (size 25, .06 taper) files were used serially
with a single controlled motion according to the manufacturer's instructions.
Group BF. For the Balanced force group, the root canals were cleaned and shaped using a #40
instrument for thin or curved canals and a #55 file for widespread canals.
Group WON. For the WaveOne group, a file (25.08) was used to prepare narrow, straight and
curved canals, and a file (40.08) was used for large and wide canals.
Three in-and-out motions were used with lengths not beyond 3 mm in the three thirds of the
canal until reaching the estimated WL.
Group REC. R25 (25.08) instrument was used in thin and curved RC, and R40 files (40.06) were
used in wide canals. Three in-and-out motions were used with lengths not beyond 3 mm in the
three thirds of the canal until reaching the estimated WL.
Hand and rotary files were employed in just 1 tooth (single use) and then excluded. AP was
conserved through all the procedures used by using a #10 K-type file at WL.
After instrumentation phase, pulp chamber was rinsed with 1 mL 2.6% NaOCl, agitated
ultrasonically. Ultrasonic activation was performed using an Irrisafe ultrasonic 20.00 tip
(Satelec, M erignac, France) at 50% power of the MiniEndo ultrasonic unit (Kerr Endo) to
place the tip 3 mm from the WL for 30 seconds per canal. Then, each experimental group
received a final irrigation with cold (6oC) 17% EDTA gently delivered to the WL using a cold
(6oC) sterile metallic micro cannula attached to the Endovac negative pressure irrigation
system (Kerr Endo) for three minutes to eliminate the smear layer and reduce post-endodontic
pain. Caution was taken to ensure that the micro cannula would suction correctly by detecting
the system's transparent evacuation tube. In case there was any obstruction, the micro
cannula was instantly substituted.
Repeat of WL was established again by using EAL as describe before using #35, #40 and # 45
files.
The root canals were then desiccated with disinfected paper cones and filled at the same
visit. Gutta-percha cones (Dentsply Maillefer) were laterally compacted with #20
nickel-titanium spreaders (Dentsply Maillefer) and AH-plus sealer (Dentsply Maillefer).
Entrance openings of anterior teeth were etched and repaired with Fuji IX (GC Corp, Tokyo,
Japan). For posterior teeth, a rebuilding was placed with the same method.
Assessment of Post-endodontic pain and Statistical Analysis Patients were informed of the
probable incidence of pain for days following RCT and received a survey form to be finished
and returned three days after. In it, they proof the occurrence or nonappearance of
post-endodontic pain, its period and level of distress rated as follows: mild pain: any
discomfort of any duration that does not require treatment; moderate pain: pain that requires
and is relieved with analgesics; and severe pain: any pain that is not calmed with treatment
(analgesics).
Outcomes were examined with the Chi-Square for the occurrence of post-endodontic pain, and
Mann-Whitney U test.
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