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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.

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 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.

Mexico1 site
  • Jose Clemente

    Tijuana, Estado de Baja California, 22000

Other trials in Mexico

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.

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 groups in NCT03424655
Study groupRoleWhat they receive
Group TFAExperimentalTwisted files were used serially with a single controlled motion according to the manufacturer's instructions.
Receives: Procedure: Twisted File Adaptive
Group BFExperimentalThe 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 WONExperimentalWaveOne 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 RECExperimentalReciproc 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.

  1. 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)
  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.

  1. First posted7 Feb 2018
  2. Study start12 Nov 2017
  3. Primary completion13 Nov 2017
  4. Study completion14 Nov 2017

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
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)
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

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.

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