Reduction of Post-endodontic Pain After Single-visit RCT Using Balanced Force and Two Reciprocating System When Intracanal Cryotherapy is Used.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 216
- Locations
- 2
- Primary Endpoint
- Evaluate the post-endodontic pain after single-visit After the root canal treatment with Balanced Force technique and two reciprocating system.
Study Overview
Brief Summary
The goal of this research was to relate the occurrence of post-endodontic pain after single-visit RCT using Balanced Force technique and two reciprocating system when cryotherapy is used. Methodology: All 216 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 216 teeth, were selected to the 3 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). WaveOne and Reciproc instruments. Final irrigation with cold (6oC) 17% EDTA served as a lubricant.
Detailed Description
Patient selection Two hundred and sixteen of 245 patients (119 women and 97 men) aged 18-65 years were incorporated in this research while 29 were excluded as not meeting the inclusion criteria. (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 size.
For hand instrumentation, the Balanced Force technique was used. All root canals were shaped with hand Flex-R files (Moyco/Union Broach, York PA, USA). Gates-Glidden drills (Dentsply Maillefer) sizes #2 and #3 were used at the orifice of the root canals. For mechanical preparations, all instruments were used with a micro motor (VDW Silver Motor, VDW, Munich Germany). Torque and rotation were preset for each Reciproc or WaveOne instrument. Rotary Ni-Ti instruments were used in continuous brushing rotary motion and reciprocating mode respectively.
Dentinal debris was eliminated from the file with a gauze, instantaneously to the instrument change (WaveOne) or after 2-3 in-and-out (pecking) movements (Reciproc) following the manufacturers' recommendations. Each root canal was irrigated with 2.5mL 2.6% NaOCl. Irrigation was performed using a 24-gauge needle (Max-I-Probe; Tulsa Dental, York, PA) and a 31-G NaviTip needle (Ultradent Products Inc, South Jordan, UT) when reaching the WL after each instrument insertion.
Group BF. For the Balanced Force group, the root canals were shaped and shaped using a #40 instrument for thin or curved canals and a #55 file for wide canals.
Group WON. For the WaveOne group, a file size 25/.08 was used to prepare narrow, straight and curved canals, and a file size 40/.08 was used for large and wide canals.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Certified endodontists trained in the procedures, devices, and systems investigated took part in the research. All experts tracked a pre-established procedure for the Balanced Force technique, WaveOne, and Reciproc instrument systems.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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).
Arms & Interventions
Group BF
The root canals were cleaned and shaped using a #40 instrument for thin or curved canals and a #55 file for widespread canals.
Intervention: Balanced Force technique (Procedure)
Group BF
The root canals were cleaned and shaped using a #40 instrument for thin or curved canals and a #55 file for widespread canals.
Intervention: WaveOne technique (Procedure)
Group BF
The root canals were cleaned and shaped using a #40 instrument for thin or curved canals and a #55 file for widespread canals.
Intervention: Reciproc technique (Procedure)
Group WON
WaveOne files was used to prepare narrow, straight and curved canals, and a file (40.08) was used for large and wide canals.
Intervention: Balanced Force technique (Procedure)
Group WON
WaveOne files was used to prepare narrow, straight and curved canals, and a file (40.08) was used for large and wide canals.
Intervention: WaveOne technique (Procedure)
Group WON
WaveOne files was used to prepare narrow, straight and curved canals, and a file (40.08) was used for large and wide canals.
Intervention: Reciproc technique (Procedure)
Reciproc instruments
Reciproc instrument was used in thin and curved RC, and R40 files (40.06) were used in wide canals.
Intervention: Balanced Force technique (Procedure)
Reciproc instruments
Reciproc instrument was used in thin and curved RC, and R40 files (40.06) were used in wide canals.
Intervention: WaveOne technique (Procedure)
Reciproc instruments
Reciproc instrument was used in thin and curved RC, and R40 files (40.06) were used in wide canals.
Intervention: Reciproc technique (Procedure)
Outcomes
Primary Outcomes
Evaluate the post-endodontic pain after single-visit After the root canal treatment with Balanced Force technique and two reciprocating system.
Time Frame: 24 hrs
Post-endodontic pain was evaluated when the RCT developed with hand and rotary instruments
Secondary Outcomes
- Use of intracanal cryotherapy on post-endodontic pain after single-visit RC(24 hrs)
Investigators
Jorge Paredes Vieyra
JORGE PAREDES VIEYRA D.D.S., MsC, PhD
Universidad Autonoma de Baja California