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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pulpotomy, Measuring Cytokines level.
- Who it may be relevant to
- Registry conditions: Pulpitis - Reversible, Occlusal Caries, Proximal Caries. Basic parameters: 4 years — 9 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- 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 irrigati - Other Measuring Cytokines level
measuring cytokines level as an indicator for pulp inflammation
Primary outcome measures
- Post operative Pain [Time frame: pain will be measured at one week , 3 months , 6 months and 12 months.]
- Preapical lesion [Time frame: will be measured at 3 months , 6 months and 12 months]
- Pain on percussion [Time frame: will be measured at 3 months , 6 months and 12 months]
- Mobility [Time frame: will be measured at 3 months , 6 months and 12 months]
Secondary outcome measures (2)
- radiographic success [Time frame: baseline data at the first visit following the procedure completion and at 6 and 12 months]
- Cytokines level [Time frame: at the time of pulpotomy procedure]
Eligibility criteria
Inclusion criteria
- Children with provoked pain.
- Caries in proximal surface to the dentine full thickness.
- Caries in occlusal surface to the dentine full thickness.
- Radicular pulp health is verified by achieving hemostasis within eight minutes of compression using a cotton pellet with 5% sodium hypochlorite.
Exclusion criteria
- Unrestorable primary molars.
- Primary molars with spontaneous pain.
- Medically compromised patients who have systemic disease.
- Uncooperative children who refuse treatment.
- Children whose parents are unwilling to place stainless steel crowns.
- Children whose parents or caregivers refuse to participate in the study or are unable to attend follow-up visits.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Egypt · 1 center
- Cairo Univeristy — Cairo
Identifiers
NCT: NCT07171229 · 14422023529314