An interventional study of MTA Pulpotomy without photobiomodulation and MTA Pulpotomy with Photobiomodulation (LLLT) in Dental Caries and Irreversible Pulpitis, sponsored by Mansoura University. Recruiting at 1 site in Egypt. Open to participants aged 6 Years to 9 Years. Per ClinicalTrials.gov, last updated 2024-12-17.
Sponsored by Mansoura University · Not applicable, Interventional, and Treatment
Among 19 studies in Dental Caries by Mansoura University — 5 open to participants now, 12 under way, none of them phase 3. Dental Caries · Mansoura University.
Among the 19 studies in Dental Caries by Mansoura University, this one is the 4th largest by planned enrollment, is one of 5 that started in 2024, is one of 19 with no phase, reaches primary completion later than 2 of the 11 other live ones, and was the 9th registered.
1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.
Browse Dental Caries studies →5 of the 19 studies in Dental Caries by Mansoura University are open now, in 1 country. Recruiting first, the newest first:
Mansoura University · Sites in Egypt
Mansoura University · Sites in Egypt
Mansoura University · Sites in Egypt
Mansoura University · Sites in Egypt
By country, each count listing its studies:
Of the 86 Dental Caries studies recruiting now, 18 (21%) set no upper age limit and 66 (77%) stop at 75 or younger; 60 take children under 18; 53 take healthy volunteers.
This study: 6 Years to 9 Years · all sexes · no healthy volunteers.
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19 studies; the count open now beside each. This study's row is marked.
First in 2019; this study’s year is marked. 5 started in 2024.
This study's planned enrollment of 72 is above the median of 60 across 967 interventional studies indexed under Dental Caries.
Median enrollment 40 across the 19 interventional studies. Of the 7 that completed or were terminated, 0 (0%) have results posted.
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Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
6 of the studies in Dental Caries by Mansoura University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07711132Mansoura UniversityRemineralizing Effect of Nano-eggshell, Casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP), and Sodium Fluoride on Initial Enamel Caries | 2026-12-20 |
| NCT07052526Mansoura UniversityComparative Evaluation of Hydrophilic and Hydrophobic Sealants in Partially Erupted First Molars | 2027-01-01 |
| NCT06265116Mansoura UniversityOne-Step Universal Adhesives: A 3-year Clinical Trial in Class II Composite Restorations | 2027-01-23 |
| NCT07849478Mansoura UniversityTwo-year Clinical Performance of Ion-releasing and Conventional Bulk-fill Resin Composite Restorative Systems. | 2027-05 |
| NCT07849426Mansoura UniversityTwo Year Clinical Performance of Ion-releasing and Non Ion-releasing Composite Restorative Systems in Restoring Cervical Carious Lesions. | 2027-05 |
Among the 19 studies in Dental Caries by Mansoura University, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will receive MTA (Mineral Trioxide Aggregate) pulpotomy as a standard treatment without the application of photobiomodulation (low-level laser therapy).
Procedure: MTA Pulpotomy without photobiomodulation
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.
Procedure: MTA Pulpotomy with Photobiomodulation (LLLT)
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.
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.
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.
Time frame: 15 months post-treatment (assessed at 3, 6, 12, and 15 months).
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).
Time frame: 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
Time frame: 15 months post-treatment (assessed at 6, 12, and 15 months)
Postoperative Pain Intensity
Measured using the Wong-Baker Faces Pain Rating Scale to assess postoperative pain levels. Wong-Baker Facial Pain Rating Scale Scale: 0 to 10 Interpretation: 0: No pain (better outcome) 10: Worst pain imaginable (worse outcome).
Time frame: 2 days post-treatment.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Jan 2026, 14 months after the start.
Of 469 non-industry interventional studies with no phase under Dental Caries, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 14 months is close to that.
Counting every sponsor, half of 502 studies reached it within 15 months; a quarter within 7 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
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