Cairo Univeristy
Cairo, Egypt
NCT Number: NCT07171229
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
Trial opening soon.
Get Notified4 year–9 year
All sexes
Interventional
Not applicable
Cairo, Egypt
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
measuring cytokines level as an indicator for pulp inflammation
Time frame: pain will be measured at one week , 3 months , 6 months and 12 months.
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Ask the patient to rate their current level of pain by placing a mark on the line. Use a ruler to measure the distance in centimetres from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10).
Time frame: will be measured at 3 months , 6 months and 12 months
by Clinical examination: presence of Swelling, sinus tract, or fistula: ,(binary outcome: present or absent )
Time frame: will be measured at 3 months , 6 months and 12 months
Tapping the tooth with the blunt end of the mirror binary outcome: present or absent
Time frame: will be measured at 3 months , 6 months and 12 months
using Miller's mobility test :involves holding the tooth firmly between two instruments and assessing its mobility on a scale from 0 to 3. A score of 0 indicates no detectable movement, while scores of 1-3 represent increasing degrees of mobility.
it will be measured as present for any score from 1 to 3 (binary: present or absent)
Time frame: baseline data at the first visit following the procedure completion and at 6 and 12 months
using Digital periapical intraoral radiograph
Radiographic Success:
Criteria for radiographic success
Time frame: at the time of pulpotomy procedure
blood sample will be collected from exposed pulp chamber before removal and IL-8 & IL-10 levels will be measured using Enzyme-linked immunoassay ( ELISA) kit. unit of measurement: ng/L
Contact information is provided by the study sponsor or research team.
Cairo University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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