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

Not Applicable

Completed

• Conditions: Periapical Periodontitis
• Interventions: Procedure: Root canal therapy in one visit; Procedure: Root Canal Therapy in two-vist

• Registration Number: NCT01312194
• Lead Sponsor: Universidade Federal do Rio de Janeiro

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.

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 Timeline

• Study Start: 2004-05
• Primary Completion: 2007-05
• Study Completion: 2008-08
• Study First Submitted: 2011-03-09
• Study First Submitted QC: 2011-03-09
• Study First Posted: 2011-03-10
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-17
• Last Update Posted: 2012-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One vist group	Root canal therapy in one visit	All patients included in this treatment group will receive the complete endodontic treatment in a single visit.
Two-vist group	Root Canal Therapy in two-vist	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.

Primary Outcome Measures

Name	Time	Method
Healing Rate of one- versus two-visit endodontic treatment	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative pain of endodontic treatment	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.

Trial Locations

Locations (1)

Federal University of Rio de Janeiro; 🇧🇷 Rio de Janeiro, Brazil