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OpenTrials
Completed

NCT Number: NCT04072926

Effects of PDT and Bioceramic Filling on Periapical Healing and Postoperative Pain After Endodontic Retreatment

The purpose is to investigate influence of bioceramic filling of the root canal and photodynamic therapy on periapical healing and development of postoperative pain after endodontic retreatment. Patients are divided into two main groups and each of the group is divided into two subgroups. Main groups are patients receiving photodynamic therapy and patients receiving passive ultrasonic irrigation. Each of the main group is divided by the root canal filling material on the AH+ group and BioRoot group.

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Key information

Conditions

Apical Periodontitis Jaw Diseases Mouth Diseases Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Dental Clinic Zagreb

Zagreb, 10000, Croatia

About this study

Clinical trial will be conducted in Dental clinic Zagreb. Patients will be chosen for this randomized prospective trials from the everyday patients referred by general dentist for endodontic retreatment. In the research will be included only patients with symptoms of chronic apical periodontitis and previous endodontic treatment. It includes teeth sensitive to palpation, percussion or visible sinus tract or swelling and asymptomatic inadequate endodontic filling. Patients that are immunocompromised, pregnant women, teeth with pocket depth bigger then 3mm, teeth with signs of vertical root fracture, teeth that are impossible to restore are excluded from research.

Every patient will be assigned to one group and one subgroup using "wheeldecide" programme. Patients will not be aware what group or subgroup they are assigned. endodontic retreatment will be conducted by one specialist in endodontics. Therapy is single visit retreatment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients with symptoms of periapical disease after endodontic treatment,
  • teeth sensitive to percussion and palpation,
  • teeth with present sinus tract and
  • asymptomatic teeth with radiologically inadequate root canal filling.

Exclusion criteria

  • Immunocompromised patients,
  • pregnancy,
  • teeth with signs of vertical root fracture,
  • teeth that can't be restored,
  • antibiotic usage within last month,
  • teeth with acute apical abscess

Treatment and study plan

BioRoot

Drug

Influence of biomaterial BioRoot on periapical healing

Other names: Photodynamic therapy

Primary outcomes

  1. Change in volume of periapical lesion

    Time frame: 1 year

    Volumetric change of size of periapical lesion depending of the root canal filling material and the use of photodynamic therapy at the end of chemomechanical preparation.

  2. Level of postoperative pain after endodontic treatment

    Time frame: 7 days day after day monitoring of the level of pain.

    After endodontic treatment receives questionaire with day - by - day monitoring of the level of pain on the scale from 0 (no pain) to 10 (sever pain)

Sponsors and collaborators

Lead sponsor

Medical Innovation Center Wroclaw

Other

Collaborators

  • University of Zagreb

Registry information

Official study title

Clinical Research of the Effects of Photodynamic Therapy and Bioceramic Filling of Root Canals on the Healing of Periapical Lesions and the Occurence of Postoperative Pain After Endodontic Retreatment

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 28, 2019
Registry last updated
Jan 19, 2023

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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