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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Mexico

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.

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 groups in NCT03559127
Study groupRoleWhat they receive
Group A. Cold Protocol with 6 oCExperimentalUse 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 oCExperimentalUse 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 ProtocolExperimentalUse 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.

  1. 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)
  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.

  1. First posted15 Jun 2018
  2. Study start7 Mar 2018
  3. Primary completion8 Mar 2018
  4. Study completion30 Apr 2018

Resources

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)
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

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.

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