NCT07171229

Evaluation of Cytokines Level as an Indicator of Pulp Inflammation and Its Relation to the Success Rates of Pulpotomy in Primary Molars Affected With Proximal Versus Occlusal Decay

Evaluation of Cytokines Level as an Indicator of Pulp Inflammation and Its Relation to the Success Rates of Pulpotomy in Primary Molars Affected With Proximal Versus Occlusal Decay: Non-Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 4 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

pulpotomy will be done I primary molars with occlusal or proximal decay and level of cytokines will be measured as an indicator for pulp inflammation levels

Detailed description

The proposed trial interventions, pulpotomy, will follow standard clinical procedural guidelines. Participants will be allocated to one of the two intervention groups only after intra-operative confirmation of pulp vitality and achievement of radicular pulp hemostasis. Standard clinical protocol for both groups with occlusal and proximal decay: 1. A detailed history of symptoms will be obtained, and a thorough clinical examination will be conducted. 2. Pre-operative pain intensity will be assessed using a validated five-face visual analog scale (VAS), where children select the face that best represents their pain level. 3. A standard pre-operative periapical radiograph will be taken, ensuring the image extends beyond the root tip and shows no distortion or processing errors. 4. Local anesthesia will be administered, and the tooth will be isolated with a rubber dam. 5. To minimize further bacterial contamination, carious tissues will be removed progressively, starting from the cavity periphery and then over the pulp chamber roof. 6. Before managing the pulpal hemorrhage, a sterile cotton pellet will be placed over the pulp tissue for 30-45 s. to obtain pulpal blood samples. The specimens will be collected into heparin-coated tubes with 1 mg saline solution and stored at - 20 °C (-4.0 °F) for 6 months until the day of testing. 7. A fresh sterile bur will be used to remove all coronal pulp tissue down to the root canal orifices, with copious water irrigation. Intra-operative assessment of pulp vitality will be conducted, with healthy vital pulp appearing as uniformly reddish-pink vascular tissue and non-vital pulp as dark avascular tissue or yellowish liquefied areas. If necrotic, the tooth will be excluded from the study, and local management protocols will be followed for treatment (Bas et al., 2024). 8. MTA will be used as medicament of choice for pulpotomy. 9. Once a 2-3 mm thickness is ensured, the cavity will be filled with restorative glass ionomer cement to seal it. 10. The pulpotomy-treated tooth will be prepared to receive a full-coverage stainless steel crown (SSC) after the procedure.

Conditions

• Pulpitis - Reversible
• Occlusal Caries
• Proximal Caries

Interventions

Type	Name	Description
PROCEDURE	Pulpotomy	* Local anesthesia will be administered, and the tooth will be isolated with a rubber dam. * To minimize further bacterial contamination, carious tissues will be removed progressively, starting from the cavity periphery and then over the pulp chamber roof. * Before managing the pulpal hemorrhage, a sterile cotton pellet will be placed over the pulp tissue for 30-45 s. * A fresh sterile bur will be used to remove all coronal pulp tissue down to the root canal orifices, with copious water irrigation * MTA will be used as medicament of choice for pulpotomy. * The pulpotomy-treated tooth will be prepared to receive a full-coverage stainless steel crown (SSC) after the procedure.
OTHER	Measuring Cytokines level	measuring cytokines level as an indicator for pulp inflammation

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-09-01
• Completion: 2026-10-01
• First posted: 2025-09-12
• Last updated: 2025-09-12

Locations

1 site across 1 country: Egypt