Clinical trial NCT03096587: Effect Of XP Endo Finisher Versus Ultrasonic Activated Irrigation On Post-operative Pain In Endodontic Treatment of Symptomatic Irreversible Pulpitis
Official title: Effect Of Using XP Endo Finisher Versus Ultrasonic Activated Irrigation On Post-operative Pain In Single Visit Endodontic Treatment of Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Symptomatic Irreversible Pulpitis
Keywords: XP Endo Finisher
ultrasonic activated irrigation
postoperative pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 44
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recruited patients with symptomatic irreversible pulpitis are assigned to interventional (XP Endo Finisher file) and control group(ultrasonic activated irrigation) to undergo single visit endodontic treatment and record postoperative pain afterwards.

Detailed description: The investigator will recruit patients from the clinic of endodontics in faculty of oral and dental medicine, Cairo university.

The patients who are found eligible to the criteria, will be randomly assigned to either the control group (ultrasonic activated irrigation )or to the intervention group( XP Endo-Finisher file). Endodontic treatment will be done in single visit.

After the visit, patients will be asked to record post operative pain by NRS (Numerical Rate Scale)in a given sheet.

Eligibility criteria: Inclusion Criteria:

1. Medically- free of any systemic disease
2. Male or female
3. Patients with age range 25-45
4. Symptomatic irreversible pulpitis in single rooted single canal teeth without apical periodontitis.
5. Teeth with mature root
6. Restorable teeth
7. Teeth without calcified root canals
8. Teeth without root caries
9. Teeth without internal or external root resorption
10. Teeth with no sign of crack formation
11. Teeth without anatomic abnormalities

Exclusion Criteria:

1. Pregnant females.
2. If analgesics have been administrated during the past two weeks preoperatively.
3. Patients having bruxism or clenching.
4. Multi rooted or multi canaled teeth.
5. Patients with swelling or acute peri-apical abscess.
6. Previously endodontically treated teeth
7. periodontally affected teeth .

Primary outcomes:
measure: post-operative pain
timeFrame: up to 1 week after the visit
Secondary outcomes:
measure: Number of taken analgesic tablets
timeFrame: within a week after the visit
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and dental medicine, Cairo University
Study officials:
affiliation: Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university
name: Nouran A Hany, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university
name: Shaimaa I Gawdat, PHD
role: STUDY_DIRECTOR
affiliation: Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university
name: Hebatallah M El-Far, Professor
role: STUDY_CHAIR
References:
citation: Alves FR, Andrade-Junior CV, Marceliano-Alves MF, Perez AR, Rocas IN, Versiani MA, Sousa-Neto MD, Provenzano JC, Siqueira JF Jr. Adjunctive Steps for Disinfection of the Mandibular Molar Root Canal System: A Correlative Bacteriologic, Micro-Computed Tomography, and Cryopulverization Approach. J Endod. 2016 Nov;42(11):1667-1672. doi: 10.1016/j.joen.2016.08.003. Epub 2016 Sep 15.
citation: Middha M, Sangwan P, Tewari S, Duhan J. Effect of continuous ultrasonic irrigation on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Int Endod J. 2017 Jun;50(6):522-530. doi: 10.1111/iej.12666. Epub 2016 Jun 28.
citation: Sadaf D, Ahmad MZ. Factors associated with postoperative pain in endodontic therapy. Int J Biomed Sci. 2014 Dec;10(4):243-7.