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CompletedNCT03120845Updated Apr 19, 2017

Incidence of Post-operative Pain After Single-visit Versus Two-visit Treatment

An interventional study of One visit RCT and Post operative pain in two-visits RCT in Post-operative Pain, sponsored by Jorge Paredes Vieyra. Completed. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-19.

Sponsored by Jorge Paredes Vieyra · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Post-operative Pain

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Keywords

  • Pain,
  • one-visit
  • two visits
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 110 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Jorge Paredes Vieyra is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. The aims and requirements of the study were freely accepted;
  2. Treatment was limited to patients in good health;
  3. All teeth had nonvital pulps and apical periodontitis, with or without a sinus tract;
  4. A negative response to hot and cold pulp sensitivity tests;
  5. Presence of sufficient coronal tooth structure for rubber dam isolation;
  6. No prior endodontic treatment on the involved tooth
  7. No analgesics or antibiotics were used five days before the clinical procedures began.

Exclusion criteria

Exclusion Criteria:

  1. Patients who did not meet inclusion requirements;
  2. Patients who did not provide authorization for participation;
  3. Patients who were younger than 16 years old;
  4. Patients who were pregnant;
  5. Patients who were diabetic;
  6. Patients with a positive history of antibiotic use within the past month;
  7. Patients whose tooth had been previously accessed or endodontically treated;
  8. Teeth with root resorption,
  9. 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    Post operative Pain in one visit RCT

    One visit RCT Ibuprofen for Post operative pain. Take 400 mg every 6 hours, a week after.

    Procedure: One visit RCT

  • Experimental
    Post operative pain in two-visits RCT

    Two visits RCT Ibuprofen for Post operative pain. Take 400 mg every 6-8 hours, a week after.

    Procedure: Post operative pain in two-visits RCT

Interventions

  • ProcedureOne visit RCT

    Root canal treatment in one vist

    Also known as: Endodontic therapy

  • ProcedurePost operative pain in two-visits RCT

    Root canal treatment in Two visits

    Also known as: Endodontic Therapy

06

What researchers measure

Primary outcomes

  1. Post-operative pain in one visit

    Pain intensity measure with general pain scale Each patient will recall a week to evaluate post operative pain

    Time frame: one week

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: Yes — Each participant will be evaluated a week after the treatment.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03120845
Lead sponsor
Jorge Paredes Vieyra
Responsible party
Jorge Paredes Vieyra (D.D.D., MsC, PhD, Universidad Autonoma de Baja California) — Sponsor-investigator
First posted
Apr 19, 2017
Start date
Feb 2, 2015
Primary completion
Feb 2, 2017
Completion
Feb 26, 2017
Last update
Apr 19, 2017

Study contacts

Miguel O Osuna, DDS
study chair · SECRETARIA DE SALUD

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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