Relate Post-endodontic PainRCTNCT03424655
Post-endodontic Pain After Single-visit Root Canal Treatment
A study testing Twisted File Adaptive, Balance Force and WaveOne in people with Relate Post-endodontic Pain, run by Jorge Paredes Vieyra 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 three reciprocating system when AP is conserved. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Relate Post-endodontic Pain
- What is being tested?
- Twisted File Adaptive, Balance Force and WaveOne
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteMexico
- Study dates
- 12 Nov 2017to 14 Nov 2017
- 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
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Relate Post-endodontic Pain
- Being tested
- Twisted File Adaptive, Balance Force, WaveOne, Reciproc technique
- Keywords
- post -endodontic pain, endodontic pain, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twisted File AdaptiveProcedure or surgery
Twisted file adaptive SM1 (size 20, .04 taper) and SM2 (size 25, .06 taper) were used serially with a single controlled motion according to the manufacturer's instructions.
Balance ForceProcedure or surgery
Flex-R files sizes 15-45 taper .02 were used according to the technique
WaveOneProcedure 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 TFA | Experimental | Twisted files were used serially with a single controlled motion according to the manufacturer's instructions. Receives: Procedure: Twisted File Adaptive |
| 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: Balance Force |
| 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: WaveOne |
| Group REC | Experimental | Reciproc instrument was used in thin and curved RC, and R40 files (40.06) were used in wide canals. Receives: Procedure: Reciproc technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of intracanal cryotherapy on post-endodontic pain after single-visit RCT using manual and reciprocating systems when Apical Patency is conserved.
Relate the post-endodontic pain after single-visit After the root canal treatment with Balanced Force technique and three reciprocating system.
Measured: 24 hrs
Secondary outcomes (1)
Use of intracanal cryotherapy on post-endodontic pain after single-visit RCT
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 posted7 Feb 2018
- Study start12 Nov 2017
- Primary completion13 Nov 2017
- Study completion14 Nov 2017
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 Relate Post-endodontic 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
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jorge Paredes Vieyra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jorge Paredes Vieyra, Universidad Autonoma de Baja California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424655
- Sponsor's protocol ID
- endodontic pain 2018
- Acronym
- RCT
- Status last verified
- Jan 2018
- First submitted
- 18 Jan 2018
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
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 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Intracanal Cryotherapy on Post-endodontic Pain After Single-visit RCT Using Manual and Reciprocating Systems When Apical Patency is Conserved.
- ClinicalTrials.gov ID
- NCT03424655
- Acronym / sponsor ID
- RCT / endodontic pain 2018
- Conditions
- Relate Post-endodontic Pain
- Keywords
- post -endodontic pain, endodontic pain, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Jorge Paredes VieyraUniversity, hospital or other
- Study start
- 12 Nov 2017 (actual)
- Primary completion
- 13 Nov 2017 (actual)
- Study completion
- 14 Nov 2017 (actual)
- First posted
- 7 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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group TFA | Experimental | Procedure: Twisted File AdaptiveTwisted files were used serially with a single controlled motion according to the manufacturer's instructions. |
| Group BF | Experimental | Procedure: Balance ForceThe 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: WaveOneWaveOne files was used to prepare narrow, straight and curved canals, and a file (40.08) was used for large and wide canals. |
| Group REC | Experimental | 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 (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
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 |
|---|---|---|
| Twisted File AdaptiveTwisted file adaptive SM1 (size 20, .04 taper) and SM2 (size 25, .06 taper) were used serially with a single controlled motion according to the manufacturer's instructions. | Procedure or surgery | Group TFA |
| Balance ForceFlex-R files sizes 15-45 taper .02 were used according to the technique | Procedure or surgery | Group BF |
| WaveOneWaveOne 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 WON |
| 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 REC |
Primary outcome
Use of intracanal cryotherapy on post-endodontic pain after single-visit RCT using manual and reciprocating systems when Apical Patency is conserved.
Time frame: 24 hrs
Relate the post-endodontic pain after single-visit After the root canal treatment with Balanced Force technique and three reciprocating system.
1 secondary outcome
Use of intracanal cryotherapy on post-endodontic pain after single-visit RCT
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 7 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. 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).
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 Twisted File Adaptive, Balance Force and WaveOne in people with Relate Post-endodontic Pain, run by Jorge Paredes Vieyra 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 2 inclusion and 1 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 7 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?
Use of intracanal cryotherapy on post-endodontic pain after single-visit RCT using manual and reciprocating systems when Apical Patency is conserved. (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 NCT03424655, 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 7 Feb 2018.