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

NCT05820750 | Unknown

• 1 other identifier: M02041022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Photodynamic Therapy

Outcome Measures

Primary Outcomes (2)

• Evaluation of clinical success of photodynamic therapy

  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.

  14 months

• Evaluation of radiographic success of photodynamic therapy

  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.

  14 months

Study Arms (3)

standard root canal treatment

OTHER

Procedure: pulpectomy with metapex

photodynamic therapy

OTHER

Device: photodynamic therapy

instrumentation and photodynamic therapy

OTHER

Device: photodynamic therapy

Interventions

photodynamic therapy DEVICE

root canal treatment of primary molars using photodynamic therapy

instrumentation and photodynamic therapy; photodynamic therapy

pulpectomy with metapex PROCEDURE

root canal treatment using standard technique

standard root canal treatment

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mohamed El Sayed Abo Farrag

Al Mansurah, 35511, Egypt

Location

MeSH Terms

Interventions

Photochemotherapy; Pulpectomy; Metapex

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Endodontics; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer at paediatric dentistry department

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 20, 2023
• Study Start: December 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

EG (1)