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

NCT02815189 | Completed Phase 2 DMC

• 1 other identifier: 52016
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pain

Keywords

pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity measure with general pain scale

  Each patient will recall a week to evaluate post operative pain

  a week

Study Arms (2)

Post operative Pain after a RCT

EXPERIMENTAL

Ibuprofen for Post operative pain. Take 400 mg taken a week after. Incidence of flare ups after a single vs multiple visits root canal treatments.

Procedure: Ibuprofen for post operative pain; Drug: Acetaminophen 325 mg for Flare up

Flare up

EXPERIMENTAL

Acetaminophen 325 mg for Flare Up. Taken second day after. Incidence of Post operative pain after root canal treatment in one vs two visits.

Procedure: Ibuprofen for post operative pain; Drug: Acetaminophen 325 mg for Flare up

Interventions

Ibuprofen for post operative pain PROCEDURE

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).

Also known as: Endodontic therapy

Flare up; Post operative Pain after a RCT

Acetaminophen 325 mg for Flare up DRUG

Each patient will be evaluated a week after completion the clinical procedures.

Also known as: Endodontic procedures

Flare up; Post operative Pain after a RCT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Baja California: lead

MeSH Terms

Conditions

Pain

Interventions

Ibuprofen; Dental Implantation, Endosseous, Endodontic; Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Endodontics; Dentistry; Prosthodontics; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Miguel O Millan, PhD

  Mexico: Secretaria de Salud

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, MsC, PhD

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 28, 2016
• Study Start: February 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 2, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share