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

Sponsor
Akademicka Poliklinika Stomatologiczna (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04072926
Collaborator
School of Dental Medicine (Other)
200
Enrollment
1
Location
4
Arms
39.5
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Each of the two main groups are divided to two subgroups.Each of the two main groups are divided to two subgroups.
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 16, 2019
Actual Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Jan 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: PDT+/BIOROOT

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.

Drug: BioRoot
Influence of biomaterial BioRoot on periapical healing
Other Names:
  • Photodynamic therapy

    		•
    Experimental: PUI/BIOROOT

    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.

    Drug: BioRoot
    Influence of biomaterial BioRoot on periapical healing
    Other Names:
  • Photodynamic therapy

    		•
    Active Comparator: PDT+/AH+

    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.

    Drug: BioRoot
    Influence of biomaterial BioRoot on periapical healing
    Other Names:
  • Photodynamic therapy

    		•
    Active Comparator: PUI/AH+

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

    Drug: BioRoot
    Influence of biomaterial BioRoot on periapical healing
    Other Names:
  • Photodynamic therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in volume of periapical lesion [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 [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dental Clinic Zagreb Zagreb Croatia 10000

    Sponsors and Collaborators

    • Akademicka Poliklinika Stomatologiczna
    • School of Dental Medicine

    Investigators

    • Principal Investigator: BORIS PAZIN, DDM, DENTAL CLINIC ZAGREB

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BORIS PAZIN, DDM, SPECIALIST IN ENDODONTICS AND RESTORATIVE DENTISTRY, Akademicka Poliklinika Stomatologiczna
    ClinicalTrials.gov Identifier:
    NCT04072926
    Other Study ID Numbers:
    • 021/002-19-208
    First Posted:
    Aug 28, 2019
    Last Update Posted:
    Feb 15, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by BORIS PAZIN, DDM, SPECIALIST IN ENDODONTICS AND RESTORATIVE DENTISTRY, Akademicka Poliklinika Stomatologiczna
    Biomaterials
    irrigation protocol
    pariapical healing
    Additional relevant MeSH terms:
    Periodontitis
    Periapical Periodontitis
    Pain, Postoperative

    Study Results

    No Results Posted as of Feb 15, 2022