Periapical Healing After One or Two-visits to Endodontic Treatment in Adolescents Patients
PHAP
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 9, 2011
CompletedFirst Posted
Study publicly available on registry
March 10, 2011
CompletedSeptember 18, 2012
September 1, 2012
3 years
March 9, 2011
September 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Healing Rate of one- versus two-visit endodontic treatment
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 Outcomes (1)
Postoperative pain of endodontic treatment
60 days
Study Arms (2)
One vist group
EXPERIMENTALAll patients included in this treatment group will receive the complete endodontic treatment in a single visit.
Two-vist group
ACTIVE COMPARATORAll 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patients healthy
- Not have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the beginning of treatment
- Lower first or second permanent molars with complete root formation and dental pulp necrosis with or without symptoms
You may not qualify if:
- Presence of periodontal diseases
- Pulp calcification
- Acute dent-alveolar abscesses
- Hemorrhage in the canal after access
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil
Related Publications (2)
Risso PA, Cunha AJ, Araujo MC, Luiz RR. Postobturation pain and associated factors in adolescent patients undergoing one- and two-visit root canal treatment. J Dent. 2008 Nov;36(11):928-34. doi: 10.1016/j.jdent.2008.07.006. Epub 2008 Sep 3.
PMID: 18771838RESULTde Andrade Risso P, da Cunha AJ, de Araujo MC, Luiz RR. Postoperative pain and associated factors in adolescent patients undergoing two-visit root canal therapy. Aust Endod J. 2009 Aug;35(2):89-92. doi: 10.1111/j.1747-4477.2008.00134.x.
PMID: 19703082RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrícia A Risso, Dentist
Universidade Federal do Rio de Janeiro
- STUDY DIRECTOR
Antonio JL Cunha, doctor
Universidade Federal do Rio de Janeiro
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PHD
Study Record Dates
First Submitted
March 9, 2011
First Posted
March 10, 2011
Study Start
May 1, 2004
Primary Completion
May 1, 2007
Study Completion
August 1, 2008
Last Updated
September 18, 2012
Record last verified: 2012-09