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

Primary Purpose

Apical Periodontitis

Status
Completed
Phase
Early Phase 1
Locations
Croatia
Study Type
Interventional
Intervention
BioRoot
Sponsored by
Akademicka Poliklinika Stomatologiczna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apical Periodontitis focused on measuring Biomaterials, irrigation protocol, pariapical healing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dental Clinic Zagreb

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

PDT+/BIOROOT

PUI/BIOROOT

PDT+/AH+

PUI/AH+

Arm Description

Photodynamic therapy will bi conducted with diode laser (660nm, 100mW, 60 seconds) with toluidine at the end of chemomechanical preparation. Final root canal filling will be with BioRoot in combination with guttapercha points.

This arm will only get PUI (passive ultrasound irrigation) with 2,5ml of 2,5% sodium hypochlorite, then 2ml of 15% EDTA which will be activated for 60seconds (EndoUltra MicroMega, France) and finally 2,5ml of 2,5% of sodium hypochlorite will be also activated for 30 seconds. Root canal filling in combination with BioRoot and guttapercha points.

Photodynamic therapy will bi conducted with diode laser (660nm, 100mW, 60 seconds) with toluidine at the end of chemomechanical preparation. Final root canal filling will be with AH+ epoxy based cement in combination with guttapercha points.

This arm will only get PUI (passive ultrasound irrigation) in combination with AH+ epoxy based cement and guttapercha points.

Outcomes

Primary Outcome Measures

Change in volume of periapical lesion
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.
Level of postoperative pain after endodontic treatment
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)

Secondary Outcome Measures

Full Information

First Posted
August 27, 2019
Last Updated
January 18, 2023
Sponsor
Akademicka Poliklinika Stomatologiczna
Collaborators
School of Dental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04072926
Brief Title
Effects of PDT and Bioceramic Filling on Periapical Healing and Postoperative Pain After Endodontic Retreatment
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 16, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akademicka Poliklinika Stomatologiczna
Collaborators
School of Dental Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Periodontitis
Keywords
Biomaterials, irrigation protocol, pariapical healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Each of the two main groups are divided to two subgroups.
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PDT+/BIOROOT
Arm Type
Experimental
Arm Description
Photodynamic therapy will bi conducted with diode laser (660nm, 100mW, 60 seconds) with toluidine at the end of chemomechanical preparation. Final root canal filling will be with BioRoot in combination with guttapercha points.
Arm Title
PUI/BIOROOT
Arm Type
Experimental
Arm Description
This arm will only get PUI (passive ultrasound irrigation) with 2,5ml of 2,5% sodium hypochlorite, then 2ml of 15% EDTA which will be activated for 60seconds (EndoUltra MicroMega, France) and finally 2,5ml of 2,5% of sodium hypochlorite will be also activated for 30 seconds. Root canal filling in combination with BioRoot and guttapercha points.
Arm Title
PDT+/AH+
Arm Type
Active Comparator
Arm Description
Photodynamic therapy will bi conducted with diode laser (660nm, 100mW, 60 seconds) with toluidine at the end of chemomechanical preparation. Final root canal filling will be with AH+ epoxy based cement in combination with guttapercha points.
Arm Title
PUI/AH+
Arm Type
Active Comparator
Arm Description
This arm will only get PUI (passive ultrasound irrigation) in combination with AH+ epoxy based cement and guttapercha points.
Intervention Type
Drug
Intervention Name(s)
BioRoot
Other Intervention Name(s)
Photodynamic therapy
Intervention Description
Influence of biomaterial BioRoot on periapical healing
Primary Outcome Measure Information:
Title
Change in volume of periapical lesion
Description
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.
Time Frame
1 year
Title
Level of postoperative pain after endodontic treatment
Description
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)
Time Frame
7 days day after day monitoring of the level of pain.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BORIS PAZIN, DDM
Organizational Affiliation
DENTAL CLINIC ZAGREB
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dental Clinic Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia

12. IPD Sharing Statement

Learn more about this trial

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

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