Reduction of Post-endodontic Pain After RCT When Intracanal Cryotherapy is Used.

Post Operative Pain Clinical Trial

— PEP  

Official title:

Reduction of Post-endodontic Pain After Single-visit RCT Using Balanced Force and Two Reciprocating System When Intracanal Cryotherapy is Used.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03448263
• Other study ID #: Endo Pain 2018
• Status: Completed
• Phase: N/A
• First received: February 15, 2018
• Last updated: February 27, 2018
• Start date: January 4, 2018
• Est. completion date: February 6, 2018

Study information

• Verified date: February 2018
• Source: Universidad Autonoma de Baja California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Three in-and-out pecking motions were used with an amplitude of not more than 3 mm until reaching the estimated working length.

Group REC. The R25 (size 25/ .08) instrument was used in thin and curved root canals, and R40 files (40/ .06) were used in wide root canals. Three in-and-out pecking motions were used with an amplitude of not more than 3 mm until reaching the estimated working length.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: February 6, 2018
• Est. primary completion date: January 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• Balanced Force technique
Flex-R files sizes 15-45 taper .02 were used according to the technique on each tooth
• WaveOne technique
WaveOne instrument was used to prepare narrow, straight and curved canals, and file (40.08) was used for large 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.
• Reciproc technique
Reciproc files 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.

Locations

Country	Name	City	State
Mexico	Jose Clemente Orozco	Tijuana	BC

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Baja California

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

Paredes-Vieyra J, Enriquez FJ. Success rate of single- versus two-visit root canal treatment of teeth with apical periodontitis: a randomized controlled trial. J Endod. 2012 Sep;38(9):1164-9. doi: 10.1016/j.joen.2012.05.021. Epub 2012 Jul 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the post-endodontic pain after single-visit After the root canal treatment with Balanced Force technique and two reciprocating system.	Post-endodontic pain was evaluated when the RCT developed with hand and rotary instruments	24 hrs
Secondary	Use of intracanal cryotherapy on post-endodontic pain after single-visit RC	A final irrigation after root canal treatment was made with cold 3cc of (6oC) 17% EDTA gently delivered to the WL using a cold (6oC) sterile metallic micro cannula.	24 hrs