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

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.

Study Overview

• Status: Completed
• Conditions: Post-operative Pain
• Intervention / Treatment: Procedure: One visit RCT; Procedure: Post operative pain in two-visits RCT

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Root canal treatment in one vist; Other Names: Endodontic therapy
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; Root canal treatment in Two visits; Other Names: Endodontic Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Jorge Paredes Vieyra
• Investigators: Study Chair: Miguel O Osuna, DDS, Secretaria de Salud

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: February 2, 2015
• Primary Completion (Actual): February 2, 2017
• Study Completion (Actual): February 26, 2017

Study Registration Dates

• First Submitted: April 14, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (Actual): April 19, 2017

Study Record Updates

• Last Update Posted (Actual): April 19, 2017
• Last Update Submitted That Met QC Criteria: April 18, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Pain,; one-visit; two visits
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Postop pain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Each participant will be evaluated a week after the treatment.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No