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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05820750
Other study ID # M02041022
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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