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

Akademicka Poliklinika Stomatologiczna

Status and phase

Completed

Early Phase 1

Conditions

Apical Periodontitis

Treatments

Drug: BioRoot

Study type

Interventional

Funder types

Other

Identifiers

NCT04072926

021/002-19-208

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 4 patient groups

PDT+/BIOROOT

Experimental group

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.

Treatment:

Drug: BioRoot

PUI/BIOROOT

Experimental group

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.

Treatment:

Drug: BioRoot

PDT+/AH+

Active Comparator group

Description:

Treatment:

Drug: BioRoot

PUI/AH+

Active Comparator group

Description:

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

Treatment: