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

NCT04072926 | Completed Early Phase 1 DMC

• 1 other identifier: 021/002-19-208
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Apical Periodontitis

Keywords

Biomaterials; irrigation protocol; pariapical healing

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  7 days day after day monitoring of the level of pain.

Study Arms (4)

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.

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.

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.

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.

Drug: BioRoot

Interventions

BioRoot DRUG

Influence of biomaterial BioRoot on periapical healing

Also known as: Photodynamic therapy

PDT+/AH+; PDT+/BIOROOT; PUI/AH+; PUI/BIOROOT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Innovation Center Wroclaw: lead
• University of Zagreb: collaborator

Study Sites (1)

Dental Clinic Zagreb

Zagreb, 10000, Croatia

Location

Related Publications (1)

• 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.

  PMID: 41375569 DERIVED

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• BORIS PAZIN, DDM

  DENTAL CLINIC ZAGREB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDM, SPECIALIST IN ENDODONTICS AND RESTORATIVE DENTISTRY

Model Details: Each of the two main groups are divided to two subgroups.

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 28, 2019
• Study Start: October 16, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: January 19, 2023

Record last verified: 2023-01

Locations

CR (1)