NCT03120845

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable postoperative-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2017

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

2 years

First QC Date

April 14, 2017

Last Update Submit

April 18, 2017

Conditions

Keywords

Pain,one-visittwo visits

Outcome Measures

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

    one week

Study Arms (2)

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.

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.

Procedure: Post operative pain in two-visits RCT

Interventions

One visit RCTPROCEDURE

Root canal treatment in one vist

Also known as: Endodontic therapy
Post operative Pain in one visit RCT

Root canal treatment in Two visits

Also known as: Endodontic Therapy
Post operative pain in two-visits RCT

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 22892729BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

Dental Implantation, Endosseous, Endodontic

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Dental Implantation, EndosseousDental ImplantationOral Surgical Procedures, PreprostheticOral Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationEndodonticsDentistryProsthodontics

Study Officials

  • Miguel O Osuna, DDS

    SECRETARIA DE SALUD

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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. Each participant received a root canal treatment (RTC)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Ibuprofen for post operative pain. after RCT in one visit
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
D.D.D., MsC, PhD

Study Record Dates

First Submitted

April 14, 2017

First Posted

April 19, 2017

Study Start

February 2, 2015

Primary Completion

February 2, 2017

Study Completion

February 26, 2017

Last Updated

April 19, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

Each participant will be evaluated a week after the treatment.