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

Primary Purpose

Periapical Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Root canal therapy in one visit
Root Canal Therapy in two-vist
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periapical Periodontitis focused on measuring Periapical Periodontitis, Dental Pulp Necrosis, Root canal Therapy, Adolescent

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Federal University of Rio de Janeiro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

One vist group

Two-vist group

Arm Description

All patients included in this treatment group will receive the complete endodontic treatment in a single visit.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 9, 2011
Last Updated
September 17, 2012
Sponsor
Universidade Federal do Rio de Janeiro
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1. Study Identification

Unique Protocol Identification Number
NCT01312194
Brief Title
Periapical Healing After One or Two-visits to Endodontic Treatment in Adolescents Patients
Acronym
PHAP
Official Title
Periapical Healing After One or Two-visits to Endodontic Treatment in Adolescents Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Periodontitis
Keywords
Periapical Periodontitis, Dental Pulp Necrosis, Root canal Therapy, Adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One vist group
Arm Type
Experimental
Arm Description
All patients included in this treatment group will receive the complete endodontic treatment in a single visit.
Arm Title
Two-vist group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Root canal therapy in one visit
Other Intervention Name(s)
One visit root canal treatment, Single visit
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Root Canal Therapy in two-vist
Other Intervention Name(s)
Multiple-visit of root canal treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Healing Rate of one- versus two-visit endodontic treatment
Description
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.
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Postoperative pain of endodontic treatment
Description
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.
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Presence of periodontal diseases Pulp calcification Acute dent-alveolar abscesses Hemorrhage in the canal after access
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrícia A Risso, Dentist
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio JL Cunha, doctor
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Study Director
Facility Information:
Facility Name
Federal University of Rio de Janeiro
City
Rio de Janeiro
ZIP/Postal Code
21941-913
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
18771838
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.
Results Reference
result
PubMed Identifier
19703082
Citation
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.
Results Reference
result

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

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