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

Post-operative Pain Clinical Trial

Official title:

Incidence of Post-operative Pain After Single-visit Versus Two-visit Root Canal Treatment of Teeth With Necrotic Pulp and Apical Periodontitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120845
• Other study ID #: Postop pain
• Status: Completed
• Phase: N/A
• First received: April 14, 2017
• Last updated: April 18, 2017
• Start date: February 2, 2015
• Est. completion date: February 26, 2017

Study information

• Verified date: April 2017
• Source: Universidad Autonoma de Baja California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 26, 2017
• Est. primary completion date: February 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

Procedure:
• One visit RCT
Root canal treatment in one vist
• Post operative pain in two-visits RCT
Root canal treatment in Two visits

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jorge Paredes Vieyra

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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