Photodynamic TherapyNCT05820750
Clinical and Radiographic Evaluation of Photodynamic Therapy for Root Canal Treatment of Primary Molars
A study testing photodynamic therapy and pulpectomy with metapex in people with Photodynamic Therapy, run by Mansoura University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Photodynamic Therapy
- What is being tested?
- photodynamic therapy and pulpectomy with metapex
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Children with compromised health or physical disability.
- Resorption of the roots more than 2/3 thirds.
- Non restorable teeth.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- photodynamic therapy, pulpectomy with metapex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photodynamic therapyDevice
root canal treatment of primary molars using photodynamic therapy
pulpectomy with metapexProcedure or surgery
root canal treatment using standard technique
| Study group | Role | What they receive |
|---|---|---|
| standard root canal treatment | Other | Not described Receives: Procedure: pulpectomy with metapex |
| photodynamic therapy | Other | Not described Receives: Device: photodynamic therapy |
| instrumentation and photodynamic therapy | Other | Not described Receives: Device: photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 months
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.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start1 Dec 2022
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photodynamic TherapyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsayed Abo Farrag, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820750
- Sponsor's protocol ID
- M02041022
- Status last verified
- Apr 2023
- First submitted
- 27 Mar 2023
- Last updated
- 20 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Photodynamic Therapy for Root Canal Treatment of Primary Molars
- ClinicalTrials.gov ID
- NCT05820750
- Acronym / sponsor ID
- M02041022
- Conditions
- Photodynamic Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard root canal treatment | Other | Procedure: pulpectomy with metapex |
| photodynamic therapy | Other | Device: photodynamic therapy |
| instrumentation and photodynamic therapy | Other | Device: photodynamic therapy |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- Children with compromised health or physical disability.
- Resorption of the roots more than 2/3 thirds.
- Non restorable teeth.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photodynamic therapyroot canal treatment of primary molars using photodynamic therapy | Device | instrumentation and photodynamic therapy, photodynamic therapy |
| pulpectomy with metapexroot canal treatment using standard technique | Procedure or surgery | standard root canal treatment |
Primary outcome
Evaluation of clinical success of photodynamic therapy
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing photodynamic therapy and pulpectomy with metapex in people with Photodynamic Therapy, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of clinical success of photodynamic therapy (time frame: 14 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.