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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05820750
Enrollment
60
Registered
2023-04-20
Start date
2022-12-01
Completion date
2024-05-01
Last updated
2023-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Photodynamic Therapy

Brief 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.

Interventions

DEVICEphotodynamic therapy

root canal treatment of primary molars using photodynamic therapy

PROCEDUREpulpectomy with metapex

root canal treatment using standard technique

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of clinical success of photodynamic therapy14 monthsThe following criteria will be used for the determination of treatment success or failure: 1. Repair (= success) Clinically: absence of signs and symptoms. 2. Lack of repair (= failure) Clinically: signs and symptoms indicative of acute apical periodontitis.
Evaluation of radiographic success of photodynamic therapy14 monthsThe following criteria will be used for the determination of treatment success or failure: 1. 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. 2. Incomplete repair (= success) Radiographically: absence of pathological root resorption and reduction lesion size in the periapical region. 3. 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026