Irreversible Pulpitis
Conditions
Keywords
partial pulpotomy , CGF
Brief summary
partial pulpotomy of mature molars with irrevesible pulptits using CGF in adolescents
Detailed description
partial pulpotomy of mature molars with irrevesible pulptits using CGF in adolescents form 12-17 years old versus endodontic treatment with a 2 years follow up
Interventions
PROCEDUREOther treatment
partial pulpotomy using CGF in irreversibly inflamed mature molars in adolescents
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
A parallel randomized controlled study that compares partial pulpotomy using CGF with endodontic treatment as a control
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Patient-based criteria: Class ASA I or II cooperative adolescents of 11 - 17 years. Based on a 10 cm modified visual analog scale (VAS), only patients who reported a preoperative pain intensity score of ≥ 7, indicative of severe pain were included. Tooth-based criteria: Presence of occlusal extremely deep carious lesion with pulp exposure of mandibular first permanent molars with closed apices (i.e. class V according to Cvek's stages of root development) with sound contralateral molars to provide a reference for biomarker quantification and pulp sensibility tests. Only teeth diagnosed with symptomatic irreversible pulpitis (SIP) were included. To validate the diagnosis of SIP, the teeth with the teeth diagnosed with symptomatic irreversible pulpitis (SIP) were included. To validate the diagnosis of SIP, the teeth with the following criteria were exclusively included: 1. History of sharp, spontaneous, and lingering pain that was precipitated by thermal provocation and lasted mostly for ≥ 30 seconds. 2. Early prolonged, intense, and lingering response to cold thermal stimulus and positive response electric pulp test (EPT) at low thresholds. 3. Normal color and appearance of the tooth surrounding gingival tissues with no evidence of gingival inflammation, swelling, abnormal tooth mobility, or sinus tract or fistula formation upon visual and palpation inspections. 4. Preoperative periapical radiograph with evidence of caries penetrating the entire thickness of the dentin with no isolating radiopaque zone separating the lesion from the pulp indicating extremely deep caries. 5. Normal radiographic findings in terms of intact periodontal membrane space
Exclusion criteria
Patient-based criteria: Patients with a positive history of the following conditions were excluded: 1. Emotional or behavioral problems and those receiving antidepressant drugs. 2. Under treatment with antibacterial or anti-inflammatory medicaments for the last four weeks (Akbal Dincer et al., 2020). 3. Localized or generalized gingivitis and/or periodontitis with loss of epithelial attachment ≥ 3mm upon probing. 4. Poor oral hygiene with dense accumulation of calculus or dental plaque. 5. Systemic conditions such as diabetes, bleeding, immunological disorders. Tooth-based criteria: 1. Teeth with abnormal structure or developmental anomalies. 2. Persistent hemorrhage from the root canal orifices lasting longer than 10 minutes. 3. Loss of coronal structure beyond restorability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome was to compare the cumulative pain responses using modified VAS scores. | one week | The primary outcome was to compare the cumulative pain responses using modified VAS scores which has a scale from 0 -10 after partial pulpotomy using CGF versus Endodontic treatment throughout one week of follow-up period. |
| Pulpal blood biomarkers | one week | Measuring Biomarker levels via quantifying NKA, SP, IL-8, and MMP-8 in pg/ml blood after partial pulpotomy using CGF versus Endodontic treatment throughout one week of follow-up period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical follow up | one week | Assess the absence of pain using VAS pain scale from 0-10 |
| Radiographic follow up | 2 years | assess the presence or absence of any signs of periapical radiolucency using parallel periapical radiographic dental x-rays using woodpecker digital sensor and its software with the Periapical Index (PAI) which has 5 scores ranging from 1-5 assessing the size of the periapical lesion after 1-, 3-, and 6-month 1 year and 2 years of follow-up |
Countries
Egypt
Contacts
CONTACTMostafa Kamel Mohamed, Master's degree
Outcome results
None listed