Post Operative PainEP18NCT03559127
Pain Reduction Using Two Cold Irrigating Protocols in Teeth With Vital Pulps.
A study testing For the Group A. Applied Cryotherapy at 6 oC and For the Group B. Applied Cryotherapy at 2.5 oC in people with Post Operative Pain, run by Universidad Autonoma de Baja California at 3 sites in Mexico.
Trial summary
The goal of this clinical research was to relate the incidence of post-endodontic pain after one-visit root canal treatment using two cold protocols of irrigation. Methodology: All 240 patients had upper or lower molar, premolar or anterior teeth selected for conventional root canal treatment for prosthetic reasons… 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?
- For the Group A. Applied Cryotherapy at 6 oC and For the Group B. Applied Cryotherapy at 2.5 oC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesMexico
- Study dates
- 7 Mar 2018to 30 Apr 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
- absence of radiographic sign of apical pathosis and a diagnosis of irreversible pulpitis (IP) and vital pulp 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 root canal therapy done before the research. 7) No painkillers or antibiotics used 7 days' prior the clinical events started.
Who cannot join
- the necessity for retreatment
- pregnancy
- impossibility to obtain patient's approval
- patients who didn't complete inclusion necessities for the research
- 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 Apical patency).
- Root fractures
Trial locations and contacts
3 sites in 1 country.
Mexico3 sites
Jorge Paredes Vieyra
Tijuana, Baja Califronia, 22000
Jorge Paredes Vieyra
Tijuana, Estado de Baja California, 22000
Jose Clemente
Tijuana, Estado de Baja California, 22000
About this study
Official title: Pain Reduction After One-visit Root Canal Treatment Using Two Cold Irrigating Protocols in Teeth With Vital Pulps.
The goal of this clinical research was to relate the incidence of post-endodontic pain after one-visit root canal treatment using two cold protocols of irrigation. Methodology: All 240 patients had upper or lower molar, premolar or anterior teeth selected for conventional root canal treatment for prosthetic reasons detected with only vital pulps (symptomatic or asymptomatic condition). Of the sample of 240 teeth, were selected to different manner to irrigate. Reciproc instruments were used with a micro motor (VDW, Munich Germany). Final irrigation with cold (6oC, 2.5 oC and room temperature 17% EDTA and saline solution served as a lubricants.
Read the detailed description
RCT was done in one-visit. Topical anesthetic (Anestesia Topica, Astra Mexico) was applied before infiltration. Patients received 2 carpules of articaine 2% with epinephrine 1:200,000 (Septodont, Saint-Maur des-Fosses, France). In circumstances in which additional anesthesia was required, intra-ligamental anesthesia (2 mL articaine 2%) was administered. For the upper teeth, the solution was injected by slow and gradual local infiltration. For the lower teeth, 1 of the carpules was used for an inferior alveolar nerve block and the other 1 for a gentle labial infiltration near the tooth to be treated.
Rubber dam was placed and the tooth was clean with 5.25% NaOCl. Preparation of the access cavity was achieved using sterile # 331 bur (Dentsply Int, York, PA), with high-speed and refrigeration. 5.25% NaOCl was employed to disinfect the coronal access. The canals were cautiously probed with #10 K-type file (Flex-R files, Moyco/Union Broach, York PA, USA).
17% EDTA (Roth International, Chicago, IL) irrigant was administered at the entrance of the canals. Working length was established with a #15 k-file and the Root ZX electronic apex locator (J Morita, Irvine CA, USA), and confirmed radiographically (Schick Technologies, NY, USA). Cervical and middle thirds of the canal was flared with a K3XF 25/10 rotary instrument (Kerr Endo, Orange County, CA) at 500 rpm. The root canal was flushed with 3 mL 5.25% sodium hypochlorite (NaOCl). A glide path to the WL was then established.
Preparations of the canals were completed with an electric motor (VDW Silver Motor, VDW, Munich Germany). Torque and rotation were predetermined for each reciproc instrument, and were used in continuous reciprocating mode.
Dentinal remains were removed from the instrument with a sterile gauze, immediately to the instrument change after two-three pull in-and-pull out (pecking) movements (Reciproc) following the manufacturers' recommendations.
Each root canal was flushed with 2.5mL 2.6% NaOCl. Irrigation was achieved 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 getting the WL after each instrument insertion. A size #10 K file was used to maintain WL after each Reciproc instrument. The established WL was checked repeatedly throughout the clinical procedures.
After instrumentation, the root canals were flushed with 1 mL 2.6% NaOCl, activated ultrasonically; It was achieved by means of an Irrisafe ultrasonic 20.00 tip (Satelec, Merignac, France) at 50% power of the Mini-Endo ultrasonic device (Kerr Endo) with the tip placed three mm from the WL for thirty seconds per root canal.
Irrigating Protocols Group A. The R25 (size 25/ .08) instrument was used in thin and curved canals, and R40 files (40/ .06) were used in broad root canals. Three in/out pecking cycles were employed with a fullness of not more than 3 mm until reaching the established WL. Patients assigned to this group receive a final irrigation with 5 mL cold (6 oC) 17% EDTA followed with 20 mL cold (6 oC) sterile saline solution dispensed to the WL using a cold (6 oC) metallic micro-cannula included in the Endo Vac System (Kerr Endo) for 5 minutes.
Group B. Canals were prepared as in group A, Patients assigned to this group receive a final irrigation with 5 mL cold (2.5 oC) 17% EDTA followed with 20 mL cold (2.5 oC) sterile saline solution dispensed to the WL using a cold (2.5 oC) metallic micro-cannula included in the Endo Vac System for five minutes.
Control Group (CG). 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 cycles were applied with a distance of not more than three mm until getting the established WL. Reciproc instruments were employed in one tooth only (single use). Patients assigned to this control group were treated identically to the experimental groups, except that receive a final flush with 5 mL (room temperature) 17% EDTA followed with twenty mL (room temperature) sterile saline solution delivered to the WL using a metallic micro-cannula included in the Endo Vac System for five minutes.
Each experimental and control group were flushed with the irrigant described above. Care was taken to confirm that the metallic cannula would aspirate properly by noticing the system's translucent evacuation duct. In case there was some obstacle, the metallic device was rapidly replaced.
Recapitulation of working length was performed again by using an apex locator as described before using #35 and #40 files.
The root canals were desiccated with disinfected paper cones and filled at the same visit. Gutta-percha points (Dentsply Maillefer) were laterally condensed with #25 nickel-titanium spreaders (Dentsply Maillefer) and AH-plus as the sealer (Dentsply Maillefer). The access cavities were etched and fixed with Fuji IX (GC Corp, Tokyo, Japan).
After these irrigation regimens, the patients were warned of the possible occurrence of pain for hours following RCT and received an evaluation form (VAS questionnaire) to be completed and give it back 72 hours after. In it, they confirmed the presence/absence of pain. The pain level was measured using a validated pain scale known as the VAS (Hawker et al. 2011). The VAS scale is a continuous measure comprised of a horizontal line, which is 10 cm in length. For pain intensity, the VAS is anchored by ''no pain'' (score of 0) and ''pain as bad as it could be'' (score of 10). The cut points on the pain VAS are no pain (0-0.5 cm), mild pain (0.6-4.0 cm), moderate pain (0.45-7.4 cm), and severe pain (7.5-10 cm) (Jensen et al. 2003). The pain VAS was completed by the patients. The patients were asked to put a mark perpendicular to the pain VAS line at the point that indicated their pain severity during the 3 days after the endodontic treatment.
234 of the two hundred and forty examinations were properly returned. 77 belonged to the group A, 78 to group B and 79 to the Control group. The missing 6 questionnaires were returned one day later and were incorporated in the examination.
The outcomes for the groups A, B and CG related to existence (yes/no), kind (mild, moderate, severe), and period (days) of pain were evaluated, and related to the following diagnostic factors: vital teeth, presence or absence of pre-operative pain, group of teeth, or ubication, age and sex, presence of occlusal contacts.
- Conditions
- Post Operative Pain
- Being tested
- For the Group A. Applied Cryotherapy at 6 oC, For the Group B. Applied Cryotherapy at 2.5 oC, Control Group (CG). Applied irrigant at room temperature
- Keywords
- post-endodontic pain, pain, criotherapy, cold irrigation
- 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.
For the Group A. Applied Cryotherapy at 6 oCProcedure or surgery
Also called Cold irrigant used after root canal treatment
Patients assigned to this group receive a final irrigation with 5 mL cold (6 oC) 17% EDTA followed with 20 mL cold (6 oC) sterile saline solution dispensed to the WL using a cold (6 oC) metallic micro-cannula included in the Endo Vac System (Kerr Endo) for 5 minutes.
For the Group B. Applied Cryotherapy at 2.5 oCProcedure or surgery
Also called Cold irrigant used after RCT
Patients assigned to this group receive a final irrigation with 5 mL cold (2.5 oC) 17% EDTA followed with 20 mL cold (2.5 oC) sterile saline solution dispensed to the WL using a cold (2.5 oC) metallic micro-cannula included in the Endo Vac System for five minutes.
Control Group (CG). Applied irrigant at room temperatureProcedure or surgery
Also called Use of Saline solution at room temperature
Patients assigned to this control group were treated identically to the experimental groups, except that receive a final flush with 5 mL (room temperature) 17% EDTA followed with twenty mL (room temperature) sterile saline solution delivered to the WL using a metallic micro-cannula included in the Endo Vac System for five minutes.
| Study group | Role | What they receive |
|---|---|---|
| Group A. Cold Protocol with 6 oC | Experimental | Use of 20 mL cold (6 oC) sterile saline solution.
After the clinical procedure cryotherapy was applied. 5 mL cold (6 oC) 17% EDTA followed with 20 mL cold (6 oC) sterile saline solution dispensed to the WL using a cold (6 oC) metallic micro-cannula included in the Endo Vac System for five minutes. Receives: Procedure: For the Group A. Applied Cryotherapy at 6 oC |
| Group B. Cold Protocol with 2.5 oC | Experimental | Use of 20 mL cold (2.5 oC) sterile saline solution
After the procedure cryotherapy was applied. 5 mL cold (2.5 oC) 17% EDTA followed with 20 mL cold (2.5 oC) sterile saline solution dispensed to the WL using a cold (2.5 oC) metallic micro-cannula included in the Endo Vac System for five minutes. Receives: Procedure: For the Group B. Applied Cryotherapy at 2.5 oC |
| CG. Room temperature Protocol | Experimental | Use of 20 mL (at room temperature) sterile saline solution
The group will receive irrigant at room temperature. 5mL of 17% EDTA and 20 mL of sterile saline usingmetallic micro-cannula included in the Endo Vac System for five minutes. Receives: Procedure: Control Group (CG). Applied irrigant at room temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the post-endodontic pain after one-visit after the root canal treatment with reciprocating NiTi system.
Pain was evaluated after 24, 48 and 72 hrs after instrumentation with reciproc NiTi instruments, the 80 canals were flushed with cold irrigants (6 and 2.5 oC). According to the VAS table provided to the participants
Measured: 24 hours to 72 hours
Secondary outcomes (1)
Evaluate the Use of intracanal cryotherapy on post-endodontic pain after single-visit RC.
Pain reduction was evaluated after a final irrigation with cold 5cc of (2.5 oC- 6 oC) 17% EDTA gently delivered to the WL using a cold (2.5- 6 oC) sterile metallic micro cannula. According to the VAS table provided to the participants
Measured: 24 hours to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start7 Mar 2018
- Primary completion8 Mar 2018
- Study completion30 Apr 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 different temperature of irrigating solution groups. Of the sample of 240 teeth, 80 were randomly assigned to the one of the 3 irrigating protocols. Treatment was performed by 3 experienced endodontists; each prepared and irrigated 80 teeth.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 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
- NCT03559127
- Sponsor's protocol ID
- Pain after RCT 2018
- Acronym
- EP18
- Status last verified
- Jun 2018
- First submitted
- 10 May 2018
- Last updated
- 15 Jun 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 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Reduction After One-visit Root Canal Treatment Using Two Cold Irrigating Protocols in Teeth With Vital Pulps.
- ClinicalTrials.gov ID
- NCT03559127
- Acronym / sponsor ID
- EP18 / Pain after RCT 2018
- Conditions
- Post Operative Pain
- Keywords
- post-endodontic pain, pain, criotherapy, cold irrigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Universidad Autonoma de Baja CaliforniaUniversity, hospital or other
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 8 Mar 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 15 Jun 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 clinical research was to relate the incidence of post-endodontic pain after one-visit root canal treatment using two cold protocols of irrigation. Methodology: All 240 patients had upper or lower molar, premolar or anterior teeth selected for conventional root canal treatment for prosthetic reasons detected with only vital pulps (symptomatic or asymptomatic condition). Of the sample of 240 teeth, were selected to different manner to irrigate. Reciproc instruments were used with a micro motor (VDW, Munich Germany). Final irrigation with cold (6oC, 2.5 oC and room temperature 17% EDTA and saline solution served as a lubricants.
Detailed description
RCT was done in one-visit. Topical anesthetic (Anestesia Topica, Astra Mexico) was applied before infiltration. Patients received 2 carpules of articaine 2% with epinephrine 1:200,000 (Septodont, Saint-Maur des-Fosses, France). In circumstances in which additional anesthesia was required, intra-ligamental anesthesia (2 mL articaine 2%) was administered. For the upper teeth, the solution was injected by slow and gradual local infiltration. For the lower teeth, 1 of the carpules was used for an inferior alveolar nerve block and the other 1 for a gentle labial infiltration near the tooth to be treated.
Rubber dam was placed and the tooth was clean with 5.25% NaOCl. Preparation of the access cavity was achieved using sterile # 331 bur (Dentsply Int, York, PA), with high-speed and refrigeration. 5.25% NaOCl was employed to disinfect the coronal access. The canals were cautiously probed with #10 K-type file (Flex-R files, Moyco/Union Broach, York PA, USA).
17% EDTA (Roth International, Chicago, IL) irrigant was administered at the entrance of the canals. Working length was established with a #15 k-file and the Root ZX electronic apex locator (J Morita, Irvine CA, USA), and confirmed radiographically (Schick Technologies, NY, USA). Cervical and middle thirds of the canal was flared with a K3XF 25/10 rotary instrument (Kerr Endo, Orange County, CA) at 500 rpm. The root canal was flushed with 3 mL 5.25% sodium hypochlorite (NaOCl). A glide path to the WL was then established.
Preparations of the canals were completed with an electric motor (VDW Silver Motor, VDW, Munich Germany). Torque and rotation were predetermined for each reciproc instrument, and were used in continuous reciprocating mode.
Dentinal remains were removed from the instrument with a sterile gauze, immediately to the instrument change after two-three pull in-and-pull out (pecking) movements (Reciproc) following the manufacturers' recommendations.
Each root canal was flushed with 2.5mL 2.6% NaOCl. Irrigation was achieved 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 getting the WL after each instrument insertion. A size #10 K file was used to maintain WL after each Reciproc instrument. The established WL was checked repeatedly throughout the clinical procedures.
After instrumentation, the root canals were flushed with 1 mL 2.6% NaOCl, activated ultrasonically; It was achieved by means of an Irrisafe ultrasonic 20.00 tip (Satelec, Merignac, France) at 50% power of the Mini-Endo ultrasonic device (Kerr Endo) with the tip placed three mm from the WL for thirty seconds per root canal.
Irrigating Protocols Group A. The R25 (size 25/ .08) instrument was used in thin and curved canals, and R40 files (40/ .06) were used in broad root canals. Three in/out pecking cycles were employed with a fullness of not more than 3 mm until reaching the established WL. Patients assigned to this group receive a final irrigation with 5 mL cold (6 oC) 17% EDTA followed with 20 mL cold (6 oC) sterile saline solution dispensed to the WL using a cold (6 oC) metallic micro-cannula included in the Endo Vac System (Kerr Endo) for 5 minutes.
Group B. Canals were prepared as in group A, Patients assigned to this group receive a final irrigation with 5 mL cold (2.5 oC) 17% EDTA followed with 20 mL cold (2.5 oC) sterile saline solution dispensed to the WL using a cold (2.5 oC) metallic micro-cannula included in the Endo Vac System for five minutes.
Control Group (CG). 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 cycles were applied with a distance of not more than three mm until getting the established WL. Reciproc instruments were employed in one tooth only (single use). Patients assigned to this control group were treated identically to the experimental groups, except that receive a final flush with 5 mL (room temperature) 17% EDTA followed with twenty mL (room temperature) sterile saline solution delivered to the WL using a metallic micro-cannula included in the Endo Vac System for five minutes.
Each experimental and control group were flushed with the irrigant described above. Care was taken to confirm that the metallic cannula would aspirate properly by noticing the system's translucent evacuation duct. In case there was some obstacle, the metallic device was rapidly replaced.
Recapitulation of working length was performed again by using an apex locator as described before using #35 and #40 files.
The root canals were desiccated with disinfected paper cones and filled at the same visit. Gutta-percha points (Dentsply Maillefer) were laterally condensed with #25 nickel-titanium spreaders (Dentsply Maillefer) and AH-plus as the sealer (Dentsply Maillefer). The access cavities were etched and fixed with Fuji IX (GC Corp, Tokyo, Japan).
After these irrigation regimens, the patients were warned of the possible occurrence of pain for hours following RCT and received an evaluation form (VAS questionnaire) to be completed and give it back 72 hours after. In it, they confirmed the presence/absence of pain. The pain level was measured using a validated pain scale known as the VAS (Hawker et al. 2011). The VAS scale is a continuous measure comprised of a horizontal line, which is 10 cm in length. For pain intensity, the VAS is anchored by ''no pain'' (score of 0) and ''pain as bad as it could be'' (score of 10). The cut points on the pain VAS are no pain (0-0.5 cm), mild pain (0.6-4.0 cm), moderate pain (0.45-7.4 cm), and severe pain (7.5-10 cm) (Jensen et al. 2003). The pain VAS was completed by the patients. The patients were asked to put a mark perpendicular to the pain VAS line at the point that indicated their pain severity during the 3 days after the endodontic treatment.
234 of the two hundred and forty examinations were properly returned. 77 belonged to the group A, 78 to group B and 79 to the Control group. The missing 6 questionnaires were returned one day later and were incorporated in the examination.
The outcomes for the groups A, B and CG related to existence (yes/no), kind (mild, moderate, severe), and period (days) of pain were evaluated, and related to the following diagnostic factors: vital teeth, presence or absence of pre-operative pain, group of teeth, or ubication, age and sex, presence of occlusal contacts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Random Selection of different temperature of irrigating solution groups. Of the sample of 240 teeth, 80 were randomly assigned to the one of the 3 irrigating protocols. Treatment was performed by 3 experienced endodontists; each prepared and irrigated 80 teeth.
| Arm | Type | Receives |
|---|---|---|
| Group A. Cold Protocol with 6 oC | Experimental | Procedure: For the Group A. Applied Cryotherapy at 6 oCUse of 20 mL cold (6 oC) sterile saline solution. After the clinical procedure cryotherapy was applied. 5 mL cold (6 oC) 17% EDTA followed with 20 mL cold (6 oC) sterile saline solution dispensed to the WL using a cold (6 oC) metallic micro-cannula included in the Endo Vac System for five minutes. |
| Group B. Cold Protocol with 2.5 oC | Experimental | Procedure: For the Group B. Applied Cryotherapy at 2.5 oCUse of 20 mL cold (2.5 oC) sterile saline solution After the procedure cryotherapy was applied. 5 mL cold (2.5 oC) 17% EDTA followed with 20 mL cold (2.5 oC) sterile saline solution dispensed to the WL using a cold (2.5 oC) metallic micro-cannula included in the Endo Vac System for five minutes. |
| CG. Room temperature Protocol | Experimental | Procedure: Control Group (CG). Applied irrigant at room temperatureUse of 20 mL (at room temperature) sterile saline solution The group will receive irrigant at room temperature. 5mL of 17% EDTA and 20 mL of sterile saline usingmetallic micro-cannula included in the Endo Vac System for five minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- absence of radiographic sign of apical pathosis and a diagnosis of irreversible pulpitis (IP) and vital pulp 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 root canal therapy done before the research. 7) No painkillers or antibiotics used 7 days' prior the clinical events started.
Key exclusion criteria (7 listed)
- the necessity for retreatment
- Root fractures
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 |
|---|---|---|
| For the Group A. Applied Cryotherapy at 6 oCAlso: Cold irrigant used after root canal treatmentPatients assigned to this group receive a final irrigation with 5 mL cold (6 oC) 17% EDTA followed with 20 mL cold (6 oC) sterile saline solution dispensed to the WL using a cold (6 oC) metallic micro-cannula included in the Endo Vac System (Kerr Endo) for 5 minutes. | Procedure or surgery | Group A. Cold Protocol with 6 oC |
| For the Group B. Applied Cryotherapy at 2.5 oCAlso: Cold irrigant used after RCTPatients assigned to this group receive a final irrigation with 5 mL cold (2.5 oC) 17% EDTA followed with 20 mL cold (2.5 oC) sterile saline solution dispensed to the WL using a cold (2.5 oC) metallic micro-cannula included in the Endo Vac System for five minutes. | Procedure or surgery | Group B. Cold Protocol with 2.5 oC |
| Control Group (CG). Applied irrigant at room temperatureAlso: Use of Saline solution at room temperaturePatients assigned to this control group were treated identically to the experimental groups, except that receive a final flush with 5 mL (room temperature) 17% EDTA followed with twenty mL (room temperature) sterile saline solution delivered to the WL using a metallic micro-cannula included in the Endo Vac System for five minutes. | Procedure or surgery | CG. Room temperature Protocol |
Primary outcome
Evaluate the post-endodontic pain after one-visit after the root canal treatment with reciprocating NiTi system.
Time frame: 24 hours to 72 hours
Pain was evaluated after 24, 48 and 72 hrs after instrumentation with reciproc NiTi instruments, the 80 canals were flushed with cold irrigants (6 and 2.5 oC). According to the VAS table provided to the participants
1 secondary outcome
Evaluate the Use of intracanal cryotherapy on post-endodontic pain after single-visit RC.
Time frame: 24 hours to 72 hours
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 15 Jun 2018.
- Background: 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
Related trials for Post Operative Pain
Recruiting
Postoperative Delirium and Analgesia in Elderly Patients
Postoperative Delirium, Postoperative Pain, Acute
Not yet recruiting
Effect of Stress Ball Use on Perioperative Anxiety and Postoperative Pain in Parturients Undergoing Cesarean Section
Postoperative Pain
Not yet recruiting
Effect of Sacral Erector Spinae Plane Block on Quality of Recovery After Cesarean Delivery: A Prospective Randomized Controlled Trial
Pain, Postoperative Pain
Not yet recruiting
VibraCool Device to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction (ACLR)
ACL, Opioid Use
RecruitingPhase 4
Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA
Periarticular Block, Osteoarthritis (OA)
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing For the Group A. Applied Cryotherapy at 6 oC and For the Group B. Applied Cryotherapy at 2.5 oC in people with Post Operative Pain, run by Universidad Autonoma de Baja California at 3 sites 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 3 inclusion and 7 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 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 one-visit after the root canal treatment with reciprocating NiTi system. (time frame: 24 hours to 72 hours). 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 NCT03559127, 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 15 Jun 2018.