Incidence of Flare-ups and Apical Healing After Single-visit or Two-visits Treatment.

Pain Clinical Trial

— FlareUp  

Official title:

Incidence of Flare-ups and Apical Healing After Single-visit or Two-visits Treatment of Teeth With Necrotic Pulp and Apical Periodontitis After a Two-year Control Period. A Randomised Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02815189
• Other study ID #: 52016
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2016
• Last updated: May 1, 2017
• Start date: February 2014
• Est. completion date: May 2016

Study information

• Verified date: May 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 flare-ups and apical healing after single-visit or two-visits treatment of teeth with necrotic pulp and apical periodontitis after a two-year control period.

110 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex. Working length was established with EAL and confirmed radiographically. M4 system with Flex-R files were used to complete canal preparation. Level of discomfort were recorded and cases with severe postoperative pain and/or swelling were classified as flare-ups.

Description:

110 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex. Working length was established with EAL and confirmed radiographically. M4 system with Flex-R files were used to complete canal preparation. Level of discomfort were recorded and cases with severe postoperative pain and/or swelling were classified as flare-ups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• a) Radiographic evidence of apical periodontitis (minimum size =2.0 mm x 2.0 mm) and a diagnosis of pulpal necrosis confirmed by negative response to hot and cold tests and b) Need for retreatment. Thermal pulp testing was performed by the author, and radiographic interpretation was verified by one certified oral surgeon.

Exclusion Criteria:

• patients without inclusion requirements or failure to obtain patient´s authorization. Patients, were excluded if they were younger than 18 years old, pregnant, had a positive history of antibiotic use within the past month, suffered from diabetes, or other systemic diseases. Teeth with periodontal pockets deeper than 4 mm also were excluded of the study.

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• Ibuprofen for post operative pain
All treatment sessions were approximately 50 minutes in length to allow for acceptable time for completion of treatment and retreatment in one or two visits. All the clinical procedures were performed by the author. Following local anesthesia with 2% lidocaine with 1:100,000 epinephrine (Septodont Saint-Maur des Fossés, France) and rubber dam isolation the tooth was disinfected with 5.25% NaOCl (Ultra bleach, Bentonville, AR, USA).

Drug:
• Acetaminophen 325 mg for Flare up
Each patient will be evaluated a week after completion the clinical procedures.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Baja California

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity measure with general pain scale	Each patient will recall a week to evaluate post operative pain	a week