Incidence of Post-operative Pain After Single-visit Versu... | NCT03120845

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

NCT03120845

Sponsor

Jorge Paredes Vieyra

Status

Completed

Last Update Posted

Apr 19, 2017Actual

Enrollment

110Actual

Phase

Not Applicable

Conditions

Post-operative Pain

Interventions

One visit RCT
Post operative pain in two-visits RCT

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2015

Primary Completion Date

Feb 2, 2017Actual

Completion Date

Feb 26, 2017Actual

First Submitted Date

Apr 14, 2017

First Submission Date that Met QC Criteria

Apr 18, 2017

First Posted Date

Apr 19, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2017

Last Update Posted Date

Apr 19, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
One visit RCT	Procedure	Root canal treatment in one vist	Post operative Pain in one visit RCT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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;
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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Miguel O Osuna, DDS	SECRETARIA DE SALUD	Study Chair

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22892729	Background	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.

ID	Term
D010149	Pain, Postoperative
D010146	Pain

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009461	Neurologic Manifestations

ID	Term
D003758	Dental Implantation, Endosseous
D003757	Dental Implantation
D013516	Oral Surgical Procedures, Preprosthetic
D019647	Oral Surgical Procedures