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

NCT ID: NCT04072926

Last Updated: 2023-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-16

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Apical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each of the two main groups are divided to two subgroups.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

BioRoot

Intervention Type DRUG

Influence of biomaterial BioRoot on periapical healing

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.

Group Type EXPERIMENTAL

BioRoot

Intervention Type DRUG

Influence of biomaterial BioRoot on periapical healing

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.

Group Type ACTIVE_COMPARATOR

BioRoot

Intervention Type DRUG

Influence of biomaterial BioRoot on periapical healing

PUI/AH+

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

Group Type ACTIVE_COMPARATOR

BioRoot

Intervention Type DRUG

Influence of biomaterial BioRoot on periapical healing

Interventions

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BioRoot

Influence of biomaterial BioRoot on periapical healing

Intervention Type DRUG

Other Intervention Names

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Photodynamic therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zagreb

OTHER

Sponsor Role collaborator

Akademicka Poliklinika Stomatologiczna

OTHER

Sponsor Role lead

Responsible Party

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BORIS PAZIN

DDM, SPECIALIST IN ENDODONTICS AND RESTORATIVE DENTISTRY

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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BORIS PAZIN, DDM

Role: PRINCIPAL_INVESTIGATOR

DENTAL CLINIC ZAGREB

Locations

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Dental Clinic Zagreb

Zagreb, , Croatia

Site Status

Countries

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Croatia

Other Identifiers

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021/002-19-208

Identifier Type: -

Identifier Source: org_study_id

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