Carious Primary Molars
Conditions
Brief summary
Will Calcium-Enriched Mixture (CEM) cement pulpotomy have less postoperative pain and more clinical and radiographic success compared to Calcium Hydroxide/Iodoform (Metapex) pulpectomy when managing second primary molars with irreversible pulpitis?
Interventions
PROCEDUREPulpotomy using Calcium-Enriched Mixture (CEM) Cement
pulpotomy procedure using (CEM) Cement as pulp dressing material
PROCEDUREPulpectomy using Calcium Hydroxide/Iodoform Paste (Metapex)
pulpectomy procdure performed using Metapex paste as root canal filling material
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
statistician
Eligibility
Sex/Gender
ALL
Age
6 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* Children: Aged 6-8 years of both sexes. Cooperative and medically free. Diagnosed with irreversible pulpitis based on clinical and radiographic criteria. Parents/legal guardians provide written informed consent. Parents able to attend follow-up visits. Teeth: Deep carious second primary molars with signs of irreversible pulpitis. No clinical signs of necrosis (abscess, fistula, mobility). No radiographic signs of necrosis (periapical lesion or resorption).
Exclusion criteria
* Children: With systemic or mental disorders. Whose parents refuse to give consent. Uncooperative behavior. Teeth: Signs of pulpal necrosis (swelling, fistula, pathological mobility). Periapical or furcal radiolucency exceeding half the furcation-apical distance. Non-restorable teeth, root caries, internal/external resorption, or calcified canals.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity | 1, 3, 6, 9, and 12 months post-treatment | Pain intensity will be evaluated using the Visual Analog Scale (VAS) of faces, rated from 0 (no pain) to 5 (severe pain). Assessment will be performed at 1, 3, 6, 9, and 12 months after treatment. Clinical success will be considered when the patient reports no pain (score = 0). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Clinical Success | 1, 3, 6, 9, and 12 months post-treatment | Clinical success will be evaluated by the absence of pain, swelling, tenderness to percussion, sinus, fistula, and pathological mobility. Clinical assessment will be performed at 1, 3, 6, 9, and 12 months postoperatively. |
| Evaluation of Radiographic Success | 6 and 12 months post-treatment | Radiographic success will be defined as the absence of widening of the periodontal ligament space, internal/external root resorption, or radiolucency in the furcation or periapical area. Radiographic failure will be recorded if any of these findings are observed. |
Contacts
Primary ContactAlaa Hassab Elrasoul Abdelmajed, Master degree
Outcome results
None listed