Clinical trial NCT04454814: Postoperative Pain After Root Canal Preparation Using Different Engine-driven Systems
Official title: Postoperative Pain Incidence of Asymptomatic Mandibular Molar Teeth After Using Different Engine-driven Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asymptomatic Molar Teeth With Periapical Lesions
Keywords: one-visit root canal treatment,
engine-driven instruments,
asymptomatic molar teeth wtih periapical lesions
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A hundred twenty patients who had an asymptomatic mandibular molar teeth with periapical lesion were included. For each patient, teeth were prepared with Reciproc Blue or Protaper Universal instruments. Each tooth was obturated with gutta-percha and resin-based sealer using single cone technique for mesial roots and for distal roots single cone and cold lateral compaction technique. Root canal treatment was performed in a single visit. Postoperative pain was assessed as no, mild, moderate, or severe at 6, 12, 24, 48, 72 hours and 7 days after obturation.

Detailed description: The aim of this study was to compare the effect of root canal preparation techniques on the occurrence and intensity of postoperative pain in patients with asymptomatic mandibular molar teeth with periapical lesions.A hundred twenty patients who had an asymptomatic mandibular molar teeth with periapical lesion were included. For each patient, teeth were prepared with Reciproc Blue or Protaper Universal instruments. Each tooth was obturated with gutta-percha and resin-based sealer using single cone technique for mesial roots and for distal roots single cone and cold lateral compaction technique. Root canal treatment was performed in a single visit. Postoperative pain was assessed as no, mild, moderate, or severe at 6, 12, 24, 48, 72 hours and 7 days after obturation.For the comparison of pain scores between the tested instrumentation systems, the Mann Whitney test was used. Differences between postoperative pain intencity for each instrumentation technique, at different time intervals, were assessed by the Friedman test. For the association of pain and an analgesic intake with gender, the chi-square test was performed. For the association of pain with age and an analgesic intake were calculated using Mann Whitney test. A P value \< .05 or less was considered significant.

Eligibility criteria: Inclusion Criteria:

* Patients without systemic diseases
* Patients who had a mandibular first molar with asymptomatic periapical lesion without previous endodontic treatment with no sensitivity to percussion
* Patients who had no spontaneous pre-treatment pain
* Patients not having taken any analgesics, antibiotics or corticosteroids before the treatment visit,
* Patients who had no allergic reaction to NaOCl and no intolerance to nonsteroidal anti-inflammatory drugs.

Exclusion Criteria:

* Patients who had severe periodontal disease
* The teeth with previous endodontic treatment
* The teeth with root canal calcification, root resorption
* The teeth that could not be isolated with rubber dam or were not suitable for further restoration

Primary outcomes:
measure: The incidence of postoperative pain
timeFrame: 6-hour to 7-day
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Gözde Kandemir Demirci
Study officials:
affiliation: Ege University Faculty of Dentistry
name: Gözde Kandemir Demirci
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University Faculty of Dentistry
name: Seniha Miçooğulları Kurt
role: STUDY_CHAIR
affiliation: Ege University Faculty of Dentistry
name: Burcu Serefoglu
role: STUDY_CHAIR
affiliation: Ege University Faculty of Dentistry
name: Mehmet E Kaval
role: STUDY_CHAIR
affiliation: Ege University Faculty of Dentistry
name: Mehmet K Çalışkan
role: STUDY_CHAIR
References:
citation: Mollashahi NF, Saberi EA, Havaei SR, Sabeti M. Comparison of Postoperative Pain after Root Canal Preparation with Two Reciprocating and Rotary Single-File Systems: A Randomized Clinical Trial. Iran Endod J. 2017 Winter;12(1):15-19. doi: 10.22037/iej.2017.03.
citation: Shokraneh A, Ajami M, Farhadi N, Hosseini M, Rohani B. Postoperative endodontic pain of three different instrumentation techniques in asymptomatic necrotic mandibular molars with periapical lesion: a prospective, randomized, double-blind clinical trial. Clin Oral Investig. 2017 Jan;21(1):413-418. doi: 10.1007/s00784-016-1807-2. Epub 2016 Apr 4.
citation: Kherlakian D, Cunha RS, Ehrhardt IC, Zuolo ML, Kishen A, da Silveira Bueno CE. Comparison of the Incidence of Postoperative Pain after Using 2 Reciprocating Systems and a Continuous Rotary System: A Prospective Randomized Clinical Trial. J Endod. 2016 Feb;42(2):171-6. doi: 10.1016/j.joen.2015.10.011. Epub 2015 Nov 29.
citation: Gambarini G, Sudani DA, Carlo SD, Pompa G, Pacifici A, Pacifici L, Testarelli L (2013) Incidence and intensivity of postoperative pain and periapical inflammation after endodontic treatment with two different instrumentation techniques. European Journal of Inflammation. 10, 99-103.