Apical PeriodontitisEarly Phase 1NCT04072926
Effects of PDT and Bioceramic Filling on Periapical Healing and Postoperative Pain After Endodontic Retreatment
A Early Phase 1 study testing BioRoot in people with Apical Periodontitis, run by Medical Innovation Center Wroclaw at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- BioRoot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCroatia
- Study dates
- 16 Oct 2019to 31 Dec 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Apical Periodontitis
- Being tested
- BioRoot
- Keywords
- Biomaterials, irrigation protocol, pariapical healing
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioRootDrug
Also called Photodynamic therapy
Influence of biomaterial BioRoot on periapical healing
| Study group | Role | What they receive |
|---|---|---|
| PDT+/BIOROOT | Experimental | 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. Receives: Drug: BioRoot |
| PUI/BIOROOT | Experimental | 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. Receives: Drug: BioRoot |
| PDT+/AH+ | Active comparator | 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. Receives: Drug: BioRoot |
| PUI/AH+ | Active comparator | This arm will only get PUI (passive ultrasound irrigation) in combination with AH+ epoxy based cement and guttapercha points. Receives: Drug: BioRoot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
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)
Measured: 7 days day after day monitoring of the level of pain.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start16 Oct 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each of the two main groups are divided to two subgroups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Innovation Center Wroclaw
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zagreb
- Responsible party
- Principal investigator, BORIS PAZIN, Medical Innovation Center Wroclaw
- Investigators
- BORIS PAZIN, DDM, Principal investigator, DENTAL CLINIC ZAGREB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072926
- Sponsor's protocol ID
- 021/002-19-208
- Status last verified
- Jan 2023
- First submitted
- 27 Aug 2019
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pazin B, Lauc T, Petricevic GK, Gabric D, Bago I. Periapical Lesion Healing After Retreatment and Root Canal Filling with a Bioceramic-Based Sealer: A Randomized Clinical Study with 1-Year Follow-Up. J Clin Med. 2025 Nov 21;14(23):8267. doi: 10.3390/jcm14238267.
PubMed 41375569
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04072926
- Acronym / sponsor ID
- 021/002-19-208
- Conditions
- Apical Periodontitis
- Keywords
- Biomaterials, irrigation protocol, pariapical healing
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Medical Innovation Center WroclawUniversity, hospital or other
- Collaborators
- University of Zagreb
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Each of the two main groups are divided to two subgroups.
| Arm | Type | Receives |
|---|---|---|
| PDT+/BIOROOT | Experimental | Drug: BioRootPhotodynamic 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. |
| PUI/BIOROOT | Experimental | Drug: BioRootThis 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. |
| PDT+/AH+ | Active comparator | Drug: BioRootPhotodynamic 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. |
| PUI/AH+ | Active comparator | Drug: BioRootThis arm will only get PUI (passive ultrasound irrigation) in combination with AH+ epoxy based cement and guttapercha points. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Immunocompromised patients,
- pregnancy,
- teeth with signs of vertical root fracture,
- teeth that can't be restored,
- antibiotic usage within last month,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioRootAlso: Photodynamic therapyInfluence of biomaterial BioRoot on periapical healing | Drug | PDT+/AH+, PDT+/BIOROOT, PUI/AH+, PUI/BIOROOT |
Primary outcome
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.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Derived from this study: PubMed 41375569Pazin B, Lauc T, Petricevic GK, Gabric D, Bago I. Periapical Lesion Healing After Retreatment and Root Canal Filling with a Bioceramic-Based Sealer: A Randomized Clinical Study with 1-Year Follow-Up. J Clin Med. 2025 Nov 21;14(23):8267. doi: 10.3390/jcm14238267.
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Necrotic Pulps With no Apical Periodontitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BORIS PAZIN, DDM principal investigator
DENTAL CLINIC ZAGREB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BioRoot in people with Apical Periodontitis, run by Medical Innovation Center Wroclaw at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in volume of periapical lesion (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04072926, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.