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Completed

NCT Number: NCT01312194

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

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.

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Key information

Conditions

Periapical Periodontitis Dental Pulp Diseases Dental Pulp Necrosis Jaw Diseases Mouth Diseases Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Periapical Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases Tooth Diseases

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Rio de Janeiro

Rio de Janeiro, 21941-913, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Root canal therapy in one visit

Procedure

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

Root Canal Therapy in two-vist

Procedure

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 names: Multiple-visit of root canal treatment

Primary outcomes

  1. Healing Rate of one- versus two-visit endodontic treatment

    Time frame: 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 outcomes

  1. Postoperative pain of endodontic treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Registry information

Acronym: PHAP

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Mar 10, 2011
Registry last updated
Sep 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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