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

Not Applicable

• Conditions: Photodynamic Therapy
• Interventions: Procedure: pulpectomy with metapex; Device: photodynamic therapy

• Registration Number: NCT05820750
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-03-27
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-06
• Last Update Submitted: 2023-04-06
• Study First Posted: 2023-04-20
• Last Update Posted: 2023-04-20
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard root canal treatment	pulpectomy with metapex	-
instrumentation and photodynamic therapy	photodynamic therapy	-
photodynamic therapy	photodynamic therapy	-

Primary Outcome Measures

Name	Time	Method
Evaluation of clinical success of photodynamic therapy	14 months	The 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 therapy	14 months	The 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.

Trial Locations

Locations (1)

Mohamed El Sayed Abo Farrag; 🇪🇬 Mansoura, Egypt