Postoperative Pain After Root Canal Preparation Using Different Engine-driven Systems

Asymptomatic Molar Teeth With Periapical Lesions Clinical Trial

Official title:

Postoperative Pain Incidence of Asymptomatic Mandibular Molar Teeth After Using Different Engine-driven Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04454814
• Other study ID #: 15-6/15
• Status: Completed
• Phase: N/A
• Start date: October 15, 2017
• Est. completion date: February 15, 2020

Study information

• Verified date: June 2020
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Asymptomatic Molar Teeth With Periapical Lesions
• Pain, Postoperative

Intervention

Other:
• Protaper Universal instruments
Root canal treatment using Protaper Universal instruments
• Reciproc Blue instruments
Root canal treatment using Reciproc Blue instruments

Locations

Country	Name	City	State
Turkey	Gözde Kandemir Demirci	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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 o

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 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of postoperative pain	Postoperative pain after 6, 12, 24, 48, 72 hours and 7 days after obturation was measured using a modified 4-grade visual analogue scale (VAS) ranging from 1(no pain), 2(mild pain), 3 (moderate pain/pain relieved by analgesics), to (4) severe pain.	6-hour to 7-day