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

Apical Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04072926
• Other study ID #: 021/002-19-208
• Status: Completed
• Phase: Early Phase 1
• Start date: October 16, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: Akademicka Poliklinika Stomatologiczna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apical Periodontitis
• Pain, Postoperative
• Periapical Periodontitis
• Periodontitis

Intervention

Drug:
• BioRoot
Influence of biomaterial BioRoot on periapical healing

Locations

Country	Name	City	State
Croatia	Dental Clinic Zagreb	Zagreb

Sponsors (2)

Lead Sponsor	Collaborator
Akademicka Poliklinika Stomatologiczna	School of Dental Medicine

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.