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

Periapical Periodontitis Clinical Trial

— PHAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01312194
• Other study ID #: 08176567-9
• Status: Completed
• Phase: N/A
• First received: March 9, 2011
• Last updated: September 17, 2012
• Start date: May 2004
• Est. completion date: August 2008

Study information

• Verified date: September 2012
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: BRAZIL: National System of Information on Ethics in Research Involving Humans
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2008
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periapical Periodontitis
• Periodontitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Federal University of Rio de Janeiro	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

de 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Postoperative pain of endodontic treatment	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	No