Post-operative PainRPEPNCT03559140
Reduction of Post-endodontic Pain After 3 Irrigation Regime
A study testing Applied saline solution at 2.5 oC (Cryotherapy group), Applied saline solution at 8oC (Cryotherapy ) and Applied saline solution at room temperature (No cryotherapy) 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 there irrigating regime. 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. 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?
- Applied saline solution at 2.5 oC (Cryotherapy group), Applied saline solution at 8oC (Cryotherapy ) and Applied saline solution at room temperature (No cryotherapy)
- 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 28 Mar 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 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 can
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Post-endodontic Pain After Single-visit RCT Using Three Irrigating Regimens.
The goal of this research was to relate the occurrence of post-endodontic pain after single-visit RCT using there irrigating regime. 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 just one method for instrumentation and different manner to irrigate. All instruments were used with a micro motor (VDW, Munich Germany). Reciproc instruments. Final irrigation with cold (8oC, 2.5 oC and room temperature 17% EDTA and saline solution served as a lubricants.
Read the detailed description
Two hundred and sixteen of 245 patients (119 women and 97 men) aged 18-65 years were referred and incorporated in this research while 29 were excluded as not meeting the inclusion criteria. All patients presented with a vital upper or lower molar, premolar or anterior teeth selected for conventional root canal treatment for prosthetic reasons.
Patients rejecting to join the study or rejecting, single-visit root canal treatment, consuming analgesics or NSAIDs were excluded too. All participants were informed on the goals, risks and strategy of the study, and written informed consent permissions were gained previous their enrollment.
Random Selection of instrumentation groups. An investigator who had not contributed in the study made the randomization arrangement using a computer random table generator (www.random.org). Each patient receive a consecutive number. A total of 216 patients met the inclusion requirements and were incorporated in the study. Of the sample of 216 teeth, 72 were randomly assigned to the one of the 3 irrigating methods. Treatment was performed by 3 experienced endodontists; each prepared 72 teeth, 24 per method.
Treatment Protocol All patients were anesthetized with two carpules of articaine 2% with epinephrine 1:200,000 (Septodont, Saint-Maur des-Fosses, France). In cases in which supplemental anesthesia was needed, intraligamental anesthesia (2 mL articaine 2%) was administered. For the upper teeth, the 2 carpules were administered by gradual infiltration in the buccal vestibule. For the lower teeth, 1.5 of the carpules was used for an inferior alveolar nerve block and the other 1.5 for a gentle buccal infiltration around the tooth to be treated.
After absolute isolation using rubber dam, the tooth was disinfected with 5.25% NaOCl. Preparation of the access cavity was performed using # 331 bur (Dentsply International, York, PA), with high-speed and water cooling. 5.25% NaOCl was used to clean the coronal cavity. The root canals were carefully probed with #10 K-type hand files (Flex-R files, Moyco/Union Broach, York PA, USA).
REDTA (Roth International, Chicago, IL) lubricant was located at the entry of the canals. Working length was determined with a #15 k-file and the Root ZX electronic device (J Morita, Irvine CA, USA), followed by subtracting 0.5 mm from the measurement, which was confirmed radiographically (Schick Technologies, NY, USA). Cervical and middle thirds of the root canal was flared with a K3XF 25/10 rotary instrument (Kerr Endo, Orange County, CA) at 500 rpm. The root canal was irrigated with 3 mL 5.25% sodium hypochlorite (NaOCl). A glide path to the WL was the established.
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 instrument. Rotary Ni-Ti instruments were used in continuous reciprocating mode.
Dentinal debris was eliminated from the file with a gauze, instantaneously to the instrument change 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. A size #10 K file was used to maintain WL after each Reciproc instrument.
Group A. 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. Patients assigned to this group receive a final irrigation with 5 mL cold (8oC) 17% EDTA followed with 20 mL cold (8oC) sterile saline solution delivered to the WL using a cold (8oC) sterile microcannula attached to 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 (2.5oC) 17% EDTA followed with 20 mL cold (2.5oC) sterile saline solution delivered to the WL using a cold (2.5oC) sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 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 pecking motions were used with an amplitude of not more than 3 mm until reaching the estimated working length. Reciproc instruments were used in one tooth only (single use). Patients assigned to this control group were treated identically to the experimental groups, except that receive a final irrigation with 5 mL (room temperature) 17% EDTA followed with 20 mL (room temperature) sterile saline solution delivered to the WL using a sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes.
After instrumentation, the root canals were irrigated with 1 mL 2.6% NaOCl, agitated ultrasonically. Ultrasonic activation was performed using an Irrisafe ultrasonic 20.00 tip (Satelec, Merignac, France) at 50% power of the MiniEndo ultrasonic unit (Kerr Endo) with the tip placed 3 mm from the working length for 30 seconds per root canal.
Each experimental and control group received a final irrigation with the irrigant described above, 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.
Recapitulation of working length was performed again by using an apex locator as described before using #35 and #40 files.
The root canals were dried with disinfected paper points and obturated at the same visit. Gutta-percha cones (Dentsply Maillefer) were laterally compacted with #20 nickel-titanium spreaders (Dentsply Maillefer) and AH-plus as the sealer (Dentsply Maillefer). The access cavities of anterior and posterior teeth were etched and repaired with Fuji IX (GC Corp, Tokyo, Japan).
Assessment of Post-endodontic pain and Statistical Analysis After these irrigation regimens, the patients were informed of the probable incidence of pain for days following RCT and received a survey form (VAS questionnaire) to be finished and returned three days after. In it, they proof the presence/absence of post-endodontic pain. The pain level was measured using a validated pain scale known as the VAS. The pain VAS is a continuous scale 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). 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.
Two hundred and ten of the 216 surveys were returned correctly returned. Of these, 69 belonged to the group A, 70 to group B and 71 to the Control group. The missing 6 questionnaires were returned one day later and were included in the data analysis.
The outcomes for the groups A, B and CG associated to occurrence (yes/no), level (mild, moderate, severe), and interval (days) of post-endodontic pain were evaluated, and related to the following diagnostic factors: condition of tooth (all vital), occurrence or nonappearance of pre-operative pain, group of teeth (molar/premolar or anterior), or location (Maxillary, Mandibular).
- Conditions
- Post-operative Pain
- Being tested
- Applied saline solution at 2.5 oC (Cryotherapy group), Applied saline solution at 8oC (Cryotherapy ), Applied saline solution at room temperature (No cryotherapy)
- Keywords
- post-endodontic pain, pain, root canal treatment, cryotherapy
- 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.
Applied saline solution at 2.5 oC (Cryotherapy group)Procedure or surgery
Patients assigned to this group will receive a final irrigation (application of cryotherapy) with 5 mL cold (8oC) 17% EDTA followed with 20 mL cold (8oC) sterile saline solution delivered to the WL using a cold (8oC) sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes.
Applied saline solution at 8oC (Cryotherapy )Procedure or surgery
Patients assigned to this group receive a final irrigation (application of cryotherapy) with 5 mL cold (2.5oC) 17% EDTA followed with 20 mL cold (2.5oC) sterile saline solution delivered to the WL using a cold (2.5oC) sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes.
Applied saline solution at room temperature (No cryotherapy)Procedure or surgery
Patients assigned to this control group were treated identically to the experimental groups, except that they will receive a final irrigation ( application of irrigant at room temperature) with 5 mL (room temperature) 17% EDTA followed with 20 mL (room temperature) sterile saline solution delivered to the WL using a sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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.
After the procedure cryotherapy will be applied as follows:
Patients assigned to this group receive a final irrigation (application of cryotherapy) with 5 mL cold (2.5oC) 17% EDTA followed with 20 mL cold (2.5oC) sterile saline solution delivered to the WL using a cold (2.5oC) sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes Receives: Procedure: Applied saline solution at 8oC (Cryotherapy ) |
| Group B | Experimental | Canals were prepared as in group A, Patients assigned to this group receive (application of criotherapy)
A final irrigation will be applied with 5 mL cold (2.5oC) 17% EDTA followed with 20 mL cold (2.5oC) sterile saline solution delivered to the WL using a cold (2.5oC) sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes. was applied. as follows:
Patients assigned to this group receive a final irrigation (application of cryotherapy) with 5 mL cold (2.5oC) 17% EDTA followed with 20 mL cold (2.5oC) sterile saline solution delivered to the WL using a cold (2.5oC) sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes Receives: Procedure: Applied saline solution at 2.5 oC (Cryotherapy group) |
| Control Group (CG) | Experimental | 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. Reciproc instruments were used in one tooth only (single use).
The group will receive the irrigant solution at room temperature. as follows:
they will receive a final irrigation ( application of irrigant at room temperature) with 5 mL (room temperature) 17% EDTA followed with 20 mL (room temperature) sterile saline solution delivered to the WL using a sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes. Receives: Procedure: Applied saline solution at room temperature (No cryotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the post-endodontic pain after 24 hrs,48 and 72 hrs.
Post-endodontic pain was evaluated after root canal treatment in order to identify in 216 patients: none, mild or severe pain.
Measured: 24 hours to 72 hours
Secondary outcomes (1)
Evaluate the effect of intracanal cryotherapy on post-endodontic pain after root canal treatment.
Post endodontic pain was evaluated after a final irrigation with cold 5cc of (2.5-8oC) 17% EDTA gently delivered to the WL using a cold (2.5-8oC) sterile metallic micro cannula.
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 start4 Jan 2018
- Primary completion5 Jan 2018
- Study completion28 Mar 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 irrigating 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
- NCT03559140
- Sponsor's protocol ID
- post endodontic pain 2018
- Acronym
- RPEP
- Status last verified
- Jun 2018
- First submitted
- 22 Apr 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
- Reduction of Post-endodontic Pain After Single-visit RCT Using Three Irrigating Regimens.
- ClinicalTrials.gov ID
- NCT03559140
- Acronym / sponsor ID
- RPEP / post endodontic pain 2018
- Conditions
- Post-operative Pain
- Keywords
- post-endodontic pain, pain, root canal treatment, cryotherapy
- 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
- 28 Mar 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 research was to relate the occurrence of post-endodontic pain after single-visit RCT using there irrigating regime. 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 just one method for instrumentation and different manner to irrigate. All instruments were used with a micro motor (VDW, Munich Germany). Reciproc instruments. Final irrigation with cold (8oC, 2.5 oC and room temperature 17% EDTA and saline solution served as a lubricants.
Detailed description
Two hundred and sixteen of 245 patients (119 women and 97 men) aged 18-65 years were referred and incorporated in this research while 29 were excluded as not meeting the inclusion criteria. All patients presented with a vital upper or lower molar, premolar or anterior teeth selected for conventional root canal treatment for prosthetic reasons.
Patients rejecting to join the study or rejecting, single-visit root canal treatment, consuming analgesics or NSAIDs were excluded too. All participants were informed on the goals, risks and strategy of the study, and written informed consent permissions were gained previous their enrollment.
Random Selection of instrumentation groups. An investigator who had not contributed in the study made the randomization arrangement using a computer random table generator (www.random.org). Each patient receive a consecutive number. A total of 216 patients met the inclusion requirements and were incorporated in the study. Of the sample of 216 teeth, 72 were randomly assigned to the one of the 3 irrigating methods. Treatment was performed by 3 experienced endodontists; each prepared 72 teeth, 24 per method.
Treatment Protocol All patients were anesthetized with two carpules of articaine 2% with epinephrine 1:200,000 (Septodont, Saint-Maur des-Fosses, France). In cases in which supplemental anesthesia was needed, intraligamental anesthesia (2 mL articaine 2%) was administered. For the upper teeth, the 2 carpules were administered by gradual infiltration in the buccal vestibule. For the lower teeth, 1.5 of the carpules was used for an inferior alveolar nerve block and the other 1.5 for a gentle buccal infiltration around the tooth to be treated.
After absolute isolation using rubber dam, the tooth was disinfected with 5.25% NaOCl. Preparation of the access cavity was performed using # 331 bur (Dentsply International, York, PA), with high-speed and water cooling. 5.25% NaOCl was used to clean the coronal cavity. The root canals were carefully probed with #10 K-type hand files (Flex-R files, Moyco/Union Broach, York PA, USA).
REDTA (Roth International, Chicago, IL) lubricant was located at the entry of the canals. Working length was determined with a #15 k-file and the Root ZX electronic device (J Morita, Irvine CA, USA), followed by subtracting 0.5 mm from the measurement, which was confirmed radiographically (Schick Technologies, NY, USA). Cervical and middle thirds of the root canal was flared with a K3XF 25/10 rotary instrument (Kerr Endo, Orange County, CA) at 500 rpm. The root canal was irrigated with 3 mL 5.25% sodium hypochlorite (NaOCl). A glide path to the WL was the established.
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 instrument. Rotary Ni-Ti instruments were used in continuous reciprocating mode.
Dentinal debris was eliminated from the file with a gauze, instantaneously to the instrument change 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. A size #10 K file was used to maintain WL after each Reciproc instrument.
Group A. 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. Patients assigned to this group receive a final irrigation with 5 mL cold (8oC) 17% EDTA followed with 20 mL cold (8oC) sterile saline solution delivered to the WL using a cold (8oC) sterile microcannula attached to 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 (2.5oC) 17% EDTA followed with 20 mL cold (2.5oC) sterile saline solution delivered to the WL using a cold (2.5oC) sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 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 pecking motions were used with an amplitude of not more than 3 mm until reaching the estimated working length. Reciproc instruments were used in one tooth only (single use). Patients assigned to this control group were treated identically to the experimental groups, except that receive a final irrigation with 5 mL (room temperature) 17% EDTA followed with 20 mL (room temperature) sterile saline solution delivered to the WL using a sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes.
After instrumentation, the root canals were irrigated with 1 mL 2.6% NaOCl, agitated ultrasonically. Ultrasonic activation was performed using an Irrisafe ultrasonic 20.00 tip (Satelec, Merignac, France) at 50% power of the MiniEndo ultrasonic unit (Kerr Endo) with the tip placed 3 mm from the working length for 30 seconds per root canal.
Each experimental and control group received a final irrigation with the irrigant described above, 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.
Recapitulation of working length was performed again by using an apex locator as described before using #35 and #40 files.
The root canals were dried with disinfected paper points and obturated at the same visit. Gutta-percha cones (Dentsply Maillefer) were laterally compacted with #20 nickel-titanium spreaders (Dentsply Maillefer) and AH-plus as the sealer (Dentsply Maillefer). The access cavities of anterior and posterior teeth were etched and repaired with Fuji IX (GC Corp, Tokyo, Japan).
Assessment of Post-endodontic pain and Statistical Analysis After these irrigation regimens, the patients were informed of the probable incidence of pain for days following RCT and received a survey form (VAS questionnaire) to be finished and returned three days after. In it, they proof the presence/absence of post-endodontic pain. The pain level was measured using a validated pain scale known as the VAS. The pain VAS is a continuous scale 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). 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.
Two hundred and ten of the 216 surveys were returned correctly returned. Of these, 69 belonged to the group A, 70 to group B and 71 to the Control group. The missing 6 questionnaires were returned one day later and were included in the data analysis.
The outcomes for the groups A, B and CG associated to occurrence (yes/no), level (mild, moderate, severe), and interval (days) of post-endodontic pain were evaluated, and related to the following diagnostic factors: condition of tooth (all vital), occurrence or nonappearance of pre-operative pain, group of teeth (molar/premolar or anterior), or location (Maxillary, Mandibular).
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 irrigating methods. Treatment was performed by 3 experienced endodontists; each prepared 72 teeth, 24 per technique.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Applied saline solution at 8oC (Cryotherapy )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. After the procedure cryotherapy will be applied as follows: Patients assigned to this group receive a final irrigation (application of cryotherapy) with 5 mL cold (2.5oC) 17% EDTA followed with 20 mL cold (2.5oC) sterile saline solution delivered to the WL using a cold (2.5oC) sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes |
| Group B | Experimental | Procedure: Applied saline solution at 2.5 oC (Cryotherapy group)Canals were prepared as in group A, Patients assigned to this group receive (application of criotherapy) A final irrigation will be applied with 5 mL cold (2.5oC) 17% EDTA followed with 20 mL cold (2.5oC) sterile saline solution delivered to the WL using a cold (2.5oC) sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes. was applied. as follows: Patients assigned to this group receive a final irrigation (application of cryotherapy) with 5 mL cold (2.5oC) 17% EDTA followed with 20 mL cold (2.5oC) sterile saline solution delivered to the WL using a cold (2.5oC) sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes |
| Control Group (CG) | Experimental | Procedure: Applied saline solution at room temperature (No cryotherapy)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. Reciproc instruments were used in one tooth only (single use). The group will receive the irrigant solution at room temperature. as follows: they will receive a final irrigation ( application of irrigant at room temperature) with 5 mL (room temperature) 17% EDTA followed with 20 mL (room temperature) sterile saline solution delivered to the WL using a sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 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 periodontitis and a diagnosis of irreversible pulpitis (IP) established by affirmative response to hot and cold examinations.
Key exclusion criteria (6 listed)
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 |
|---|---|---|
| Applied saline solution at 2.5 oC (Cryotherapy group)Patients assigned to this group will receive a final irrigation (application of cryotherapy) with 5 mL cold (8oC) 17% EDTA followed with 20 mL cold (8oC) sterile saline solution delivered to the WL using a cold (8oC) sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes. | Procedure or surgery | Group B |
| Applied saline solution at 8oC (Cryotherapy )Patients assigned to this group receive a final irrigation (application of cryotherapy) with 5 mL cold (2.5oC) 17% EDTA followed with 20 mL cold (2.5oC) sterile saline solution delivered to the WL using a cold (2.5oC) sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes. | Procedure or surgery | Group A |
| Applied saline solution at room temperature (No cryotherapy)Patients assigned to this control group were treated identically to the experimental groups, except that they will receive a final irrigation ( application of irrigant at room temperature) with 5 mL (room temperature) 17% EDTA followed with 20 mL (room temperature) sterile saline solution delivered to the WL using a sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes. | Procedure or surgery | Control Group (CG) |
Primary outcome
Evaluate the post-endodontic pain after 24 hrs,48 and 72 hrs.
Time frame: 24 hours to 72 hours
Post-endodontic pain was evaluated after root canal treatment in order to identify in 216 patients: none, mild or severe pain.
1 secondary outcome
Evaluate the effect of intracanal cryotherapy on post-endodontic pain after root canal treatment.
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.
- 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 Applied saline solution at 2.5 oC (Cryotherapy group), Applied saline solution at 8oC (Cryotherapy ) and Applied saline solution at room temperature (No cryotherapy) 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 3 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 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 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 24 hrs,48 and 72 hrs. (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 NCT03559140, 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.