Irreversible Pulpitis, Apical Periodontitis
Conditions
Brief summary
This randomized controlled clinical trial evaluates the effect of different methods of cryotherapy (extra-oral, intra-canal, and combination) on postoperative pain and periapical Substance P levels in patients with acute irreversible pulpitis and symptomatic apical periodontitis. Forty participants will be divided into four groups to compare the therapeutic benefits of cold applications in endodontic treatment
Interventions
PROCEDUREExtra-oral Cryotherapy
Application of extra-oral cold packs (on the cheek) for 30 minutes after the conventional root canal treatment
PROCEDUREIntra-canal Cryotherapy
Application of intra-canal cold (2-4°C) 2.5% NaOCl irrigation after the conventional root canal treatment
PROCEDURECombination (extra-oral and intra-canal)
Received both extra-oral gel pack and intra-canal cold NaOCl applications (as previous) after the conventional root canal treatment
PROCEDUREConventional Endodontic Treatment
Standard root canal treatment without the application of cryotherapy
Sponsors
Ahmad badrah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Candidates received a comprehensive explanation of the study, provided written informed consent, and agreed to complete the full trial. * Patients having lower molars with vital pulp \& irreversible pulpitis. * Patients with apical periodontitis were selected based on severe preoperative and percussion pain, defined as a visual analogue scale (VAS) score greater than 7. * The absence of periapical radiolucency on radiographs.
Exclusion criteria
* History of systemic disease. * Vulnerable population: prisoners, pregnant women, mentally ill people, etc. * Patients took analgesics before treatment * A radiographically calcified canal * A previous endodontic treatment * Sinus tracts * Local gingival inflammation around the offended tooth * Severe periodontal disease * Presence of periodontal pockets \>3 mm in the affected tooth * No bleeding observed upon access cavity preparation * Inaccurate working length determination * Separated instruments, over instrumentation, and overfilling or under filling * Resorption * Periapical radiolucency * Anatomical variations as, excessively curved root or Prescence radix, excessively long or short roots,teeth with open apices
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | Measured at 6, 12, 24, and 48 hours and 1 week postoperatively | Assessment of postoperative pain intensity using the Visual Analog Scale (VAS) or Numerical Rating Scale (NRS) at specific intervals |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| substance P (SP) Levels | Assessed immediately after the conventional root canal preparation, and subsequently after the application of cryotherapy for the experimental groups or after 30 minutes for the control group | Evaluation of Substance P concentration in periapical tissue fluid as a biochemical marker for inflammation |
Countries
Egypt
Outcome results
None listed