Periapical Healing After One or Two-visits to Endodontic Treatment in Adolescents Patients (PHAP)

September 17, 2012 updated by: Patricia de Andrade Risso, Universidade Federal do Rio de Janeiro
The main objective of this study is the prevention and repair of apical periodontitis in lower molars with pulp necrosis after the execution of endodontic treatment in one or two visits in adolescent patients. Moreover, it is also observed the frequency of postoperative pain in endodontic treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This project is developed in adolescent patients who have need of endodontic treatment in necrotic molars. The patients were randomly divided into two groups of treatment: one and two visits. The treatment protocol is the same for both groups, except the number of visits and the use of intra canal medication in the group treated in two visits. Patients will be followed clinically and radiographically for a minimum period of two years. The data was collected by the evaluation of postoperative pain and to determine the healing of periapical lesions, characterizing the success of the treatment.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 21941-913
        • Federal University of Rio de Janeiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients healthy
  2. Not have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the beginning of treatment
  3. Lower first or second permanent molars with complete root formation and dental pulp necrosis with or without symptoms

Exclusion Criteria:

  1. Presence of periodontal diseases
  2. Pulp calcification
  3. Acute dent-alveolar abscesses
  4. Hemorrhage in the canal after access

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: One vist group
All patients included in this treatment group will receive the complete endodontic treatment in a single visit.
Procedure: Root canal therapy in one visit
Patient was anesthetized with local anesthetic solutions, and the caries was removed. The tooth was isolated with rubber dam and access to pulp chamber was completed. Cleaning and shaping preparation was achieved with manual and rotatory endodontic instruments.The ideal working length was determined by an electronic apex locator and periapical radiography. Irrigation was performed with 5.25%NaOCl solution. The smear layer was removed by 10% citric acid. The cases were obturated with guta-percha cones using a lateral compaction filling technique as well as zinc oxide-eugenol-based root canal sealer. The teeth filled with a light-cured resin.
Other Names:
  • One visit root canal treatment
  • Single visit
ACTIVE_COMPARATOR: Two-vist group
All patients included in this treatment group will receive treatment in two visits. The first will be done chemo mechanical root canal preparation, the placement of the intracanal medication the basis of calcium hydroxide and coronal sealing. Ten to twelve days later, this medication is removed and the root canal will be permanently filled.
Procedure: Root Canal Therapy in two-vist
The treatment protocol was the same as described for one visit group. In the first visit, after cleaning, shaping and smear layer removal, the root canals were medicated with a calcium hydroxide paste and sterile distilled water (1:1) and the pulp chamber was sealed with a minimum 3mm thickness temporary filling restoration. After 10-12 days, during the second visit, the medication was removed, and the cases were obturated with guta-percha cones using a lateral compaction filling technique as well as zinc oxide-eugenol-based root canal sealer. The teeth filled with a light-cured resin.
Other Names:
  • Multiple-visit of root canal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing Rate of one- versus two-visit endodontic treatment
Time Frame: Two years
After completion of endodontic treatment in one or two visits, patients will be followed clinically and radiographically every 06 months for a minimum of two years to assess the prevention and repair of apical periodontitis.
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain of endodontic treatment
Time Frame: 60 days
Following the completion of endodontic treatment in one or two visits, patients receive a clinical record for home monitoring of postoperative pain and return to clinic to conduct a follow-up clinical and radiographic. Pain is assessed using a numerical scale for pain.
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio de Janeiro

Investigators

  • Principal Investigator: Patrícia A Risso, Dentist, Universidade Federal do Rio de Janeiro
  • Study Director: Antonio JL Cunha, doctor, Universidade Federal do Rio de Janeiro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (ACTUAL)

May 1, 2007

Study Completion (ACTUAL)

August 1, 2008

Study Registration Dates

First Submitted

March 9, 2011

First Submitted That Met QC Criteria

March 9, 2011

First Posted (ESTIMATE)

March 10, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 18, 2012

Last Update Submitted That Met QC Criteria

September 17, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08176567-9

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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