Clinical and Radiographic Evaluation of Photodynamic Therapy for Root Canal Treatment of Primary Molars

Photodynamic Therapy Clinical Trial

Official title:

Clinical and Radiographic Evaluation of Photodynamic Therapy for Root Canal Treatment of Primary Molars

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05820750
• Other study ID #: M02041022
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: April 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be conducted to evaluate clinical and radiographic success of Photodynamic Therapy for root canal treatment of primary molars in comparison to the standard root canal treatment.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

Inclusion Criteria:

• Children aged 4-7 years.
• Apparent healthy child not suffering from any mental or physical disability.
• Cooperative children.
• Restorable teeth.
• Each child should have at least one carious primary molar with signs and symptoms of irreversible pulpitis or pulp necrosis.
• Absence of internal and / or external perforation in the furcation area.
• At least 2/3 thirds of the roots should be remained.

Exclusion Criteria:

• Children with compromised health or physical disability.
• Resorption of the roots more than 2/3 thirds.
• Non restorable teeth.

Related Conditions & MeSH terms

• Photodynamic Therapy

Intervention

Device:
• photodynamic therapy
root canal treatment of primary molars using photodynamic therapy

Procedure:
• pulpectomy with metapex
root canal treatment using standard technique

Locations

Country	Name	City	State
Egypt	Mohamed El Sayed Abo Farrag	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of clinical success of photodynamic therapy	The following criteria will be used for the determination of treatment success or failure: Repair (= success) Clinically: absence of signs and symptoms.; Lack of repair (= failure) Clinically: signs and symptoms indicative of acute apical periodontitis.	14 months
Primary	Evaluation of radiographic success of photodynamic therapy	The following criteria will be used for the determination of treatment success or failure: Complete repair (= success) Radiographically: absence of pathological root resorption, normal width of periodontal ligament space, absence of lesion development in periapical regions in cases of absence of lesion in the initial diagnostic radiograph and complete regression of lesion in cases of presence of lesion in the initial diagnostic radiograph.; Incomplete repair (= success) Radiographically: absence of pathological root resorption and reduction lesion size in the periapical region.; Lack of repair (= failure) Radiographically: presence of pathological root resorption, lesion in furcation/periapical region unchanged in size during follow-up period, increase in lesion size or the development of a new lesion.	14 months