Post Operative PainPEPNCT03448263
Reduction of Post-endodontic Pain After RCT When Intracanal Cryotherapy is Used.
A study testing Balanced Force technique, WaveOne technique and Reciproc technique in people with Post Operative Pain, run by Universidad Autonoma de Baja California at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Balanced Force technique, WaveOne technique and Reciproc technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteMexico
- Study dates
- 4 Jan 2018to 6 Feb 2018
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Post-endodontic Pain After Single-visit RCT Using Balanced Force and Two Reciprocating System When Intracanal Cryotherapy is Used.
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.
Read the 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.
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.
- Conditions
- Post Operative Pain
- Being tested
- Balanced Force technique, WaveOne technique, Reciproc technique
- Keywords
- pain, post endodontic pain, root canal treatment
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balanced Force techniqueProcedure or surgery
Flex-R files sizes 15-45 taper .02 were used according to the technique on each tooth
WaveOne techniqueProcedure or surgery
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 techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group BF | Experimental | The root canals were cleaned and shaped using a #40 instrument for thin or curved canals and a #55 file for widespread canals. Receives: Procedure: Balanced Force technique; Procedure: WaveOne technique; Procedure: Reciproc technique |
| Group WON | Experimental | WaveOne files was used to prepare narrow, straight and curved canals, and a file (40.08) was used for large and wide canals. Receives: Procedure: Balanced Force technique; Procedure: WaveOne technique; Procedure: Reciproc technique |
| Reciproc instruments | Experimental | Reciproc instrument was used in thin and curved RC, and R40 files (40.06) were used in wide canals. Receives: Procedure: Balanced Force technique; Procedure: WaveOne technique; Procedure: Reciproc technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hrs
Secondary outcomes (1)
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.
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start4 Jan 2018
- Primary completion5 Jan 2018
- Study completion6 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Random Selection of instrumentation groups. Of the sample of 216 teeth, 72 were randomly assigned to the one of the 3 instrumentation methods. Treatment was performed by 3 experienced endodontists; each prepared 72 teeth, 24 per technique.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Baja California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Paredes Vieyra, Universidad Autonoma de Baja California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448263
- Sponsor's protocol ID
- Endo Pain 2018
- Acronym
- PEP
- Status last verified
- Feb 2018
- First submitted
- 15 Feb 2018
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22892729
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Post-endodontic Pain After Single-visit RCT Using Balanced Force and Two Reciprocating System When Intracanal Cryotherapy is Used.
- ClinicalTrials.gov ID
- NCT03448263
- Acronym / sponsor ID
- PEP / Endo Pain 2018
- Conditions
- Post Operative Pain
- Keywords
- pain, post endodontic pain, root canal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Universidad Autonoma de Baja CaliforniaUniversity, hospital or other
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 5 Jan 2018 (actual)
- Study completion
- 6 Feb 2018 (actual)
- First posted
- 28 Feb 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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Random Selection of instrumentation groups. Of the sample of 216 teeth, 72 were randomly assigned to the one of the 3 instrumentation methods. Treatment was performed by 3 experienced endodontists; each prepared 72 teeth, 24 per technique.
| Arm | Type | Receives |
|---|---|---|
| Group BF | Experimental | Procedure: Balanced Force technique, Procedure: WaveOne technique, Procedure: Reciproc techniqueThe root canals were cleaned and shaped using a #40 instrument for thin or curved canals and a #55 file for widespread canals. |
| Group WON | Experimental | Procedure: Balanced Force technique, Procedure: WaveOne technique, Procedure: Reciproc techniqueWaveOne files was used to prepare narrow, straight and curved canals, and a file (40.08) was used for large and wide canals. |
| Reciproc instruments | Experimental | Procedure: Balanced Force technique, Procedure: WaveOne technique, Procedure: Reciproc techniqueReciproc instrument was used in thin and curved RC, and R40 files (40.06) were used in wide canals. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Balanced Force techniqueFlex-R files sizes 15-45 taper .02 were used according to the technique on each tooth | Procedure or surgery | Group BF, Group WON, Reciproc instruments |
| WaveOne techniqueWaveOne 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. | Procedure or surgery | Group BF, Group WON, Reciproc instruments |
| Reciproc techniqueReciproc 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. | Procedure or surgery | Group BF, Group WON, Reciproc instruments |
Primary outcome
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
1 secondary outcome
Use of intracanal cryotherapy on post-endodontic pain after single-visit RC
Time frame: 24 hrs
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 28 Feb 2018.
- Results publication: PubMed 22892729Paredes-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.
- 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 Balanced Force technique, WaveOne technique and Reciproc technique in people with Post Operative Pain, run by Universidad Autonoma de Baja California at 1 site in Mexico.
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 4 inclusion and 6 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 28 Feb 2018. 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 Mexico. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03448263, which also lists 1 linked publication.
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 28 Feb 2018.