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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Patricia de Andrade Risso, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01312194
First received: March 9, 2011
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Periapical Periodontitis
Procedure: Root canal therapy in one visit
Procedure: Root Canal Therapy in two-vist

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Periapical Healing After One or Two-visits to Endodontic Treatment in Adolescents Patients

Further study details as provided by Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • Healing Rate of one- versus two-visit endodontic treatment [ Time Frame: Two years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Postoperative pain of endodontic treatment [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 120
Study Start Date: May 2004
Study Completion Date: August 2008
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Multiple-visit of root canal 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.

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312194

Locations
Brazil
Federal University of Rio de Janeiro
Rio de Janeiro, Brazil, 21941-913
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Patricia de Andrade Risso, PHD, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01312194     History of Changes
Other Study ID Numbers: 08176567-9
Study First Received: March 9, 2011
Last Updated: September 17, 2012
Health Authority: BRAZIL: National System of Information on Ethics in Research Involving Humans

Keywords provided by Universidade Federal do Rio de Janeiro:
Periapical Periodontitis
Dental Pulp Necrosis
Root canal Therapy
Adolescent

Additional relevant MeSH terms:
Periapical Periodontitis
Periodontitis
Jaw Diseases
Mouth Diseases
Periapical Diseases
Periodontal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 19, 2014