Irreversible Pulpitis
Conditions
Keywords
Vital pulp therapy, Pulp cap, pulpotomy, calcium enriched mixture, CEM cement, Endodontic
Brief summary
To compare the effect of different VPT methods using Calcium Enriched Mixture (CEM) cement for management of human dental pulp with irreversible pulpitis.
Detailed description
The purpose of this randomized clinical trial is to demonstrate the effect of four methods of Vital Pulp Therapy (VPT) using a new endodontic bio-material \[calcium enriched mixture (CEM) cement\] in pain relief as well as clinical/radiographic success, for management of irreversible pulpitis of human permanent teeth.
Interventions
PROCEDUREIndirect pulp capping (IPC)
Procedure: IPC The IPC will be performed as follow: * Anesthesia * isolation the tooth * access to the lesion * incomplete removal of carious tissue from the cavity walls * indirect pulp capping with ≈2 mm layer calcium enriched mixture cement * permanent filling with sandwich technique
PROCEDUREDirect pulp capping (DPC)
Procedure: DPC The DPC will be performed as follow: * Anesthesia * isolation the tooth * access to the lesion * complete removal of carious tissue from the cavity walls result in pulp exposure * preparation of clot-free pulpal mound * direct pulp capping with ≈2 mm layer calcium enriched mixture cement * permanent filling with sandwich technique
PROCEDUREMiniature pulpotomy (MP)
Procedure: MP The MP will be performed as follow: * Anesthesia * isolation the tooth * access to the lesion * complete removal of carious tissue from the cavity walls result in pulp exposure * intentionally removal of pulp horn (≈1 mm) * preparation of clot-free pulpal mound * direct pulp capping with ≈2 mm layer calcium enriched mixture cement * permanent filling with sandwich technique
PROCEDUREFull pulpotomy (FP)
Procedure: FP The FP will be performed as follow: * Anesthesia * isolation the tooth * access to the lesion * complete removal of carious tissue from the cavity walls result in pulp exposure * pulpotomy * preparation of clot-free pulpal mound * direct pulp capping with ≈2 mm layer calcium enriched mixture cement * permanent filling with sandwich technique
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Carious permanent vital mature molar tooth with closed apex (with preoperative X-ray) 2. Positive response to EPT or cold test 3. patients willing to participate in study 4. Healthy subjects; absence of any systematic disorder 5. Age ≥ 10 years old 6. Both gender 7. Written informed consent
Exclusion criteria
1. Moderate or severe periodontitis; pockets \>3mm 2. None restorable tooth 3. Internal or external root resorption 4. Root canal calcification 5. Non vital pulps 6. Analgesic taken within the last 8h 7. Active systemic disease 8. Pregnancy or nursing 9. History of opioid addiction/abuse 10. Temporary residency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical and radiographical success rates (%) of each treatment group | 1 year | The outcome of clinical success/failure is determined by subjective symptoms and objective observation of inflammation/infection. The outcome of radiographic success is classified by using a modification of the Strindberg criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Assessment of Pain with questionnaire | 6-months | Pain assessment is carried out using the pain Numerical Rating Scale (NRS) with ratings between 0 to 9. Pain assessment is made up to 7 days. One NRS form is given to each patient to complete. |
Countries
Iran
Outcome results
None listed