Post-operative PainNCT03120845
Incidence of Post-operative Pain After Single-visit Versus Two-visit Treatment
A study testing One visit RCT and Post operative pain in two-visits RCT in people with Post-operative Pain, run by Jorge Paredes Vieyra.
Trial summary
Aim :to compare incidence of post-operative pain and apical healing after single-visit versus two-visit root canal treatment of teeth with necrotic pulp and apical periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- One visit RCT and Post operative pain in two-visits RCT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2015to 26 Feb 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The aims and requirements of the study were freely accepted;
- Treatment was limited to patients in good health;
- All teeth had nonvital pulps and apical periodontitis, with or without a sinus tract;
- A negative response to hot and cold pulp sensitivity tests;
- Presence of sufficient coronal tooth structure for rubber dam isolation;
- No prior endodontic treatment on the involved tooth
- No analgesics or antibiotics were used five days before the clinical procedures began.
Who cannot join
- Patients who did not meet inclusion requirements;
- Patients who did not provide authorization for participation;
- Patients who were younger than 16 years old;
- Patients who were pregnant;
- Patients who were diabetic;
- Patients with a positive history of antibiotic use within the past month;
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- Patients whose tooth had been previously accessed or endodontically treated;
- Teeth with root resorption,
- Immature/open apex, or a root canal in which patency of the apical foramen could not be established were all excluded from the study. Teeth with periodontal pockets deeper than 4 mm also were excluded of the study.
About this study
Official title: Incidence of Post-operative Pain After Single-visit Versus Two-visit Root Canal Treatment of Teeth With Necrotic Pulp and Apical Periodontitis
Aim :to compare incidence of post-operative pain and apical healing after single-visit versus two-visit root canal treatment of teeth with necrotic pulp and apical periodontitis.
Read the detailed description
Aim to compare incidence of post-operative pain and apical healing after single-visit versus two-visit root canal treatment of teeth with necrotic pulp and apical periodontitis.
Methodology: All teeth of the one and two-visit group were asymptomatic (92) and symptomatic (18) with a diagnosis of pulp necrosis (RCT cases) determined by hot and cold sensitivity tests and radiographically all teeth showed a small and irregular radiolucency at the tooth apex. Working length was established with EAL and confirmed radiographically. Reciprocating files (VDW, Munich Germany) were used to complete root canal preparation. EDTA served as a lubricant.
- Conditions
- Post-operative Pain
- Being tested
- One visit RCT, Post operative pain in two-visits RCT
- Keywords
- Pain,, one-visit, two visits
- 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.
One visit RCTProcedure or surgery
Also called Endodontic therapy
Root canal treatment in one vist
Post operative pain in two-visits RCTProcedure or surgery
Also called Endodontic Therapy
Root canal treatment in Two visits
| Study group | Role | What they receive |
|---|---|---|
| Post operative Pain in one visit RCT | Experimental | One visit RCT Ibuprofen for Post operative pain. Take 400 mg every 6 hours, a week after. Receives: Procedure: One visit RCT |
| Post operative pain in two-visits RCT | Experimental | Two visits RCT Ibuprofen for Post operative pain. Take 400 mg every 6-8 hours, a week after. Receives: Procedure: Post operative pain in two-visits RCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain in one visit
Pain intensity measure with general pain scale Each patient will recall a week to evaluate post operative pain
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start2 Feb 2015
- Primary completion2 Feb 2017
- Study completion26 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Parallel groups
- Model description
- Ibuprofen for post operative pain. after RCT in one visit
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jorge Paredes Vieyra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jorge Paredes Vieyra, Universidad Autonoma de Baja California
- Investigators
- Miguel O Osuna, DDS, Study chair, SECRETARIA DE SALUD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120845
- Sponsor's protocol ID
- Postop pain
- Status last verified
- Apr 2017
- First submitted
- 14 Apr 2017
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Each participant will be evaluated a week after the treatment.
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 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Post-operative Pain After Single-visit Versus Two-visit Root Canal Treatment of Teeth With Necrotic Pulp and Apical Periodontitis
- ClinicalTrials.gov ID
- NCT03120845
- Acronym / sponsor ID
- Postop pain
- Conditions
- Post-operative Pain
- Keywords
- Pain,, one-visit, two visits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Jorge Paredes VieyraUniversity, hospital or other
- Study start
- 2 Feb 2015
- Primary completion
- 2 Feb 2017 (actual)
- Study completion
- 26 Feb 2017 (actual)
- First posted
- 19 Apr 2017 (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.
Aim :to compare incidence of post-operative pain and apical healing after single-visit versus two-visit root canal treatment of teeth with necrotic pulp and apical periodontitis.
Detailed description
Aim to compare incidence of post-operative pain and apical healing after single-visit versus two-visit root canal treatment of teeth with necrotic pulp and apical periodontitis.
Methodology: All teeth of the one and two-visit group were asymptomatic (92) and symptomatic (18) with a diagnosis of pulp necrosis (RCT cases) determined by hot and cold sensitivity tests and radiographically all teeth showed a small and irregular radiolucency at the tooth apex. Working length was established with EAL and confirmed radiographically. Reciprocating files (VDW, Munich Germany) were used to complete root canal preparation. EDTA served as a lubricant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Ibuprofen for post operative pain. after RCT in one visit
| Arm | Type | Receives |
|---|---|---|
| Post operative Pain in one visit RCT | Experimental | Procedure: One visit RCTOne visit RCT Ibuprofen for Post operative pain. Take 400 mg every 6 hours, a week after. |
| Post operative pain in two-visits RCT | Experimental | Procedure: Post operative pain in two-visits RCTTwo visits RCT Ibuprofen for Post operative pain. Take 400 mg every 6-8 hours, a week after. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The aims and requirements of the study were freely accepted;
- Treatment was limited to patients in good health;
- All teeth had nonvital pulps and apical periodontitis, with or without a sinus tract;
- A negative response to hot and cold pulp sensitivity tests;
- Presence of sufficient coronal tooth structure for rubber dam isolation;
Key exclusion criteria (9 listed)
- Patients who did not meet inclusion requirements;
- Patients who did not provide authorization for participation;
- Patients who were younger than 16 years old;
- Patients who were pregnant;
- Patients who were diabetic;
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 |
|---|---|---|
| One visit RCTAlso: Endodontic therapyRoot canal treatment in one vist | Procedure or surgery | Post operative Pain in one visit RCT |
| Post operative pain in two-visits RCTAlso: Endodontic TherapyRoot canal treatment in Two visits | Procedure or surgery | Post operative pain in two-visits RCT |
Primary outcome
Post-operative pain in one visit
Time frame: one week
Pain intensity measure with general pain scale Each patient will recall a week to evaluate post operative pain
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 19 Apr 2017.
- 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: Yes. Each participant will be evaluated a week after the treatment.
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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.
Miguel O Osuna, DDS study chair
SECRETARIA DE SALUD
Questions about this trial
What is this clinical trial studying?
A study testing One visit RCT and Post operative pain in two-visits RCT in people with Post-operative Pain, run by Jorge Paredes Vieyra.
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 7 inclusion and 9 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 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Post-operative pain in one visit (time frame: one week). 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 NCT03120845, 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 19 Apr 2017.