Dental CariesNCT06730360
Clinical and Radiographic Assessment of Photobiomodulated MTA Pulpotomy in Immature First Permanent Molars with Irreversible Pulpitis
A study testing MTA Pulpotomy without photobiomodulation and MTA Pulpotomy with Photobiomodulation (LLLT) in people with Dental Caries and Irreversible Pulpitis, run by Mansoura University at 1 site in Egypt.
Trial summary
This study evaluates the effectiveness of photobiomodulation (PBM) in conjunction with mineral trioxide aggregate (MTA) pulpotomy for treating irreversible pulpitis in immature first permanent molars. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Dental Caries, Irreversible Pulpitis
- What is being tested?
- MTA Pulpotomy without photobiomodulation and MTA Pulpotomy with Photobiomodulation (LLLT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2024to 5 Apr 2026
- 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 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6 to 9 years.
- Non-contributory medical history (healthy otherwise).
- Presence of carious first permanent molars with the following characteristics:
- Deep caries extending to ≥2/3 of dentin.
- Positive response to cold testing.
- Clinical diagnosis of irreversible pulpitis (moderate or severe), with or without periapical periodontitis.
Show all 9Show fewer
- Restorable tooth.
- Probing pocket depth and mobility within normal limits.
- No signs of pulpal necrosis, including sinus tract or swelling.
Who cannot join
- Insufficient bleeding after pulp exposure (indicating necrotic or partially necrotic pulp).
- Presence of systemic or medical conditions that may contraindicate participation.
- Teeth with unrestorable structure.
- Teeth showing signs of pulpal necrosis, such as the presence of a sinus tract or swelling.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Al Mansurah, Dakahlia Governorate, 35516
peter samir abdelshahed, +201141859508, petersamir@mans.edu.eg
About this study
Official title: Clinical and Radiographic Assessment of Photobiomodulated MTA Pulpotomy in Immature First Permanent Molars with Irreversible Pulpitis: a Randomized Controlled Clinical Trial
This study evaluates the effectiveness of photobiomodulation (PBM) in conjunction with mineral trioxide aggregate (MTA) pulpotomy for treating irreversible pulpitis in immature first permanent molars. PBM, also known as low-level laser therapy (LLLT), is used to enhance healing, reduce inflammation, and manage pain in young teeth. The randomized clinical trial involves 72 children aged 6-9 years, divided into two groups: one receiving MTA pulpotomy alone and the other receiving MTA pulpotomy with PBM. Clinical and radiographic outcomes will be assessed at intervals over 15 months. This research aims to determine the combined therapy's efficacy in improving pulp healing and reducing post-operative discomfort compared to MTA alone.
Read the detailed description
This randomized controlled trial evaluates the clinical and radiographic outcomes of MTA pulpotomy, with and without PBM, for immature permanent molars diagnosed with irreversible pulpitis. The study includes two parallel groups of 36 children each. Group I will undergo MTA pulpotomy alone, while Group II will receive PBM treatment alongside MTA pulpotomy.
PBM employs low-level laser therapy to stimulate pulp tissue regeneration, enhance mitochondrial activity, and reduce inflammation and pain, thereby potentially improving MTA pulpotomy outcomes. Key inclusion criteria involve children with deep carious lesions and clinical signs of irreversible pulpitis but without pulpal necrosis. Follow-up will occur at 3, 6, 12, and 15 months post-treatment to evaluate success based on the absence of clinical symptoms (e.g., pain, tenderness) and radiographic indicators of healing.
By comparing these two approaches, the study aims to provide insights into PBM's role as an adjunctive therapy for vital pulp preservation, particularly in pediatric dentistry.
- Conditions
- Dental Caries, Irreversible Pulpitis
- Being tested
- MTA Pulpotomy without photobiomodulation, MTA Pulpotomy with Photobiomodulation (LLLT)
- Keywords
- Irreversible pulpitis, Immature permanent molars, Vital pulp therapy (VPT), Mineral trioxide aggregate (MTA), Photobiomodulation (PBM)
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTA Pulpotomy without photobiomodulationProcedure or surgery
This intervention involves the application of Mineral Trioxide Aggregate (MTA) to the pulp chamber after the removal of the coronal pulp tissue in first permanent molars with irreversible pulpitis. The procedure is performed without the use of photobiomodulation (low-level laser therapy). The MTA is placed as a seal to preserve the vitality of the remaining radicular pulp.
MTA Pulpotomy with Photobiomodulation (LLLT)Procedure or surgery
This intervention combines MTA pulpotomy with photobiomodulation (low-level laser therapy). After performing the MTA pulpotomy, low-level laser therapy is applied to the pulp stumps to reduce inflammation, promote healing, and modulate pain. The laser therapy uses specific wavelengths of light to stimulate cellular activity and enhance the regeneration of pulp tissue.
| Study group | Role | What they receive |
|---|---|---|
| MTA Pulpotomy without Photobiomodulation | Active comparator | Participants will receive MTA (Mineral Trioxide Aggregate) pulpotomy as a standard treatment without the application of photobiomodulation (low-level laser therapy). Receives: Procedure: MTA Pulpotomy without photobiomodulation |
| MTA Pulpotomy with Photobiomodulation | Experimental | Participants will receive MTA (Mineral Trioxide Aggregate) pulpotomy treatment enhanced with photobiomodulation (low-level laser therapy). The laser will be applied to pulp stumps before the placement of MTA to promote healing and reduce inflammation.
These entries should resolve the error and align with your protocol. Receives: Procedure: MTA Pulpotomy with Photobiomodulation (LLLT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success of Pulpotomy Treatment
Evaluation of clinical signs and symptoms (absence of pain, tenderness to percussion, sinus tract, or swelling). Treatment is considered successful if these are absent at all follow-up visits.
Measured: 15 months post-treatment (assessed at 3, 6, 12, and 15 months).
Secondary outcomes (2)
Radiographic Healing
Assessment of radiographic evidence of healing, including no periapical rarefaction, root resorption, or new furcal pathosis. Success is determined by achieving a PAI (Periapical Index) score of 1 or 2, or reduction in PAI score if preoperative rarefaction is present.
Periapical Index (PAI) Scale: 1 to 5
Interpretation:
1: Normal periapical structures (better outcome) 5: Severe changes with evident bone destruction (worse outcome).
Measured: 15 months post-treatment (assessed at 6, 12, and 15 months).
Root Development Progression
Radiographic evaluation of root maturity and the formation of a hard tissue bridge
Measured: 15 months post-treatment (assessed at 6, 12, and 15 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start10 Oct 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion5 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Samir, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730360
- Sponsor's protocol ID
- A0109024PP
- Status last verified
- Sep 2024
- First submitted
- 9 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- 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 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Assessment of Photobiomodulated MTA Pulpotomy in Immature First Permanent Molars with Irreversible Pulpitis: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06730360
- Acronym / sponsor ID
- A0109024PP
- Conditions
- Dental Caries, Irreversible Pulpitis
- Keywords
- Irreversible pulpitis, Immature permanent molars, Vital pulp therapy (VPT), Mineral trioxide aggregate (MTA), Photobiomodulation (PBM)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 5 Apr 2026 (estimated)
- First posted
- 12 Dec 2024 (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 evaluates the effectiveness of photobiomodulation (PBM) in conjunction with mineral trioxide aggregate (MTA) pulpotomy for treating irreversible pulpitis in immature first permanent molars. PBM, also known as low-level laser therapy (LLLT), is used to enhance healing, reduce inflammation, and manage pain in young teeth. The randomized clinical trial involves 72 children aged 6-9 years, divided into two groups: one receiving MTA pulpotomy alone and the other receiving MTA pulpotomy with PBM. Clinical and radiographic outcomes will be assessed at intervals over 15 months. This research aims to determine the combined therapy's efficacy in improving pulp healing and reducing post-operative discomfort compared to MTA alone.
Detailed description
This randomized controlled trial evaluates the clinical and radiographic outcomes of MTA pulpotomy, with and without PBM, for immature permanent molars diagnosed with irreversible pulpitis. The study includes two parallel groups of 36 children each. Group I will undergo MTA pulpotomy alone, while Group II will receive PBM treatment alongside MTA pulpotomy.
PBM employs low-level laser therapy to stimulate pulp tissue regeneration, enhance mitochondrial activity, and reduce inflammation and pain, thereby potentially improving MTA pulpotomy outcomes. Key inclusion criteria involve children with deep carious lesions and clinical signs of irreversible pulpitis but without pulpal necrosis. Follow-up will occur at 3, 6, 12, and 15 months post-treatment to evaluate success based on the absence of clinical symptoms (e.g., pain, tenderness) and radiographic indicators of healing.
By comparing these two approaches, the study aims to provide insights into PBM's role as an adjunctive therapy for vital pulp preservation, particularly in pediatric dentistry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTA Pulpotomy without Photobiomodulation | Active comparator | Procedure: MTA Pulpotomy without photobiomodulationParticipants will receive MTA (Mineral Trioxide Aggregate) pulpotomy as a standard treatment without the application of photobiomodulation (low-level laser therapy). |
| MTA Pulpotomy with Photobiomodulation | Experimental | Procedure: MTA Pulpotomy with Photobiomodulation (LLLT)Participants will receive MTA (Mineral Trioxide Aggregate) pulpotomy treatment enhanced with photobiomodulation (low-level laser therapy). The laser will be applied to pulp stumps before the placement of MTA to promote healing and reduce inflammation. These entries should resolve the error and align with your protocol. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children aged 6 to 9 years.
- Non-contributory medical history (healthy otherwise).
- Presence of carious first permanent molars with the following characteristics:
- Deep caries extending to ≥2/3 of dentin.
- Positive response to cold testing.
Key exclusion criteria (4 listed)
- Insufficient bleeding after pulp exposure (indicating necrotic or partially necrotic pulp).
- Presence of systemic or medical conditions that may contraindicate participation.
- Teeth with unrestorable structure.
- Teeth showing signs of pulpal necrosis, such as the presence of a sinus tract or swelling.
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 |
|---|---|---|
| MTA Pulpotomy without photobiomodulationThis intervention involves the application of Mineral Trioxide Aggregate (MTA) to the pulp chamber after the removal of the coronal pulp tissue in first permanent molars with irreversible pulpitis. The procedure is performed without the use of photobiomodulation (low-level laser therapy). The MTA is placed as a seal to preserve the vitality of the remaining radicular pulp. | Procedure or surgery | MTA Pulpotomy without Photobiomodulation |
| MTA Pulpotomy with Photobiomodulation (LLLT)This intervention combines MTA pulpotomy with photobiomodulation (low-level laser therapy). After performing the MTA pulpotomy, low-level laser therapy is applied to the pulp stumps to reduce inflammation, promote healing, and modulate pain. The laser therapy uses specific wavelengths of light to stimulate cellular activity and enhance the regeneration of pulp tissue. | Procedure or surgery | MTA Pulpotomy with Photobiomodulation |
Primary outcome
Clinical Success of Pulpotomy Treatment
Time frame: 15 months post-treatment (assessed at 3, 6, 12, and 15 months).
Evaluation of clinical signs and symptoms (absence of pain, tenderness to percussion, sinus tract, or swelling). Treatment is considered successful if these are absent at all follow-up visits.
2 secondary outcomes
Radiographic Healing
Time frame: 15 months post-treatment (assessed at 6, 12, and 15 months).
Root Development Progression
Time frame: 15 months post-treatment (assessed at 6, 12, and 15 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MTA Pulpotomy without photobiomodulation and MTA Pulpotomy with Photobiomodulation (LLLT) in people with Dental Caries and Irreversible Pulpitis, 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 9 inclusion and 4 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 17 Dec 2024. 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?
Contact peter samir abdelshahed, assistant lecture (+201141859508, petersamir@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success of Pulpotomy Treatment (time frame: 15 months post-treatment (assessed at 3, 6, 12, and 15 months).). 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 17 Dec 2024.