Clinical trial NCT04228913: Effect of Different Obturation Techniques on Postoperative Pain
Official title: Comparison of Postoperative Pain Intensity After Three Different Obturation Techniques: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Pain
Endodontic Inflammation
Keywords: cold lateral condensation
Postoperative Pain
GuttaCore
GuttaFlow 2
Obturation Techniques
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single (Participant)
Primary purpose: OTHER

Brief summary: This study evaluated the postoperative pain after the endodontic treatment by using three different obturation techniques. ( Cold lateral condensation (CLC), thermoplasticized solid-core carrier method (GuttaCore) and cold free-flow compation tecnique ( GuttaFlow2))


Eligibility criteria: Inclusion Criteria:

1. Participants between 18 - 72 years of ages,

2 Good oral hygiene,

3. Have not taken any analgesic in the last 7 days,

4. Have not taken any antibiotics in the last 7 days,

5. Positive response to both cold test (EndoIce; Coltene/Whaledent Inc, Cuyahoga ),

6. Patients diagnosed with asymptomatic irreversible pulpitis with his/her single-rooted teeth caused by a deep carious lesion,

7. Patients have single-rooted teeth requiring endodontic treatment according to the pre-prosthetic reason,

8.The presence of profusely pulp bleeding with a thick consistency, which is exposed during caries removing.

9. The periapical region was healthy in radiographic diagnosis.

Exclusion Criteria:

1. Patients who refuse to participate in this study,
2. Medically compromised patients (with immunosuppressive/systemic diseases, patients on medications),
3. Devital teeth that have no response to pulp test,
4. The presence of advanced periodontal disease (probing depth \> 4 mm),
5. The presence of open apex,
6. The presence of calcification,
7. The presence of resorption,
8. Patients who had multiple teeth requiring endodontic treatment,
9. Patients with allergic sensitivity to materials and agents that should be used during the root canal treatment,
10. Allergic sensitivity to local anesthetics,
11. Patients who had systemic or allergic sensitivity for the NSAIDs,
12. Pregnant participants or participants in the lactation period,
13. Teeth cannot be applied to a rubber-dam.

Primary outcomes:
measure: Pain level comparison after root canal obturation with three different obturation technique:: VAS (Visual Analogue Scale) at 6th hours.
timeFrame: 6th hours.
measure: Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 12th hours.
timeFrame: 12th hours.
measure: Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 24th hours
timeFrame: 24th hours.
measure: Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 2nd days.
timeFrame: 2nd days
measure: Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 3th days.
timeFrame: 3th days
measure: Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 4th days.
timeFrame: 4th days.
measure: Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 5th days.
timeFrame: 5th days
measure: Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 6th days.
timeFrame: 6th days
measure: Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 7th days.
timeFrame: 7th days
Secondary outcomes:
measure: Analgesic intake comparison after root canal obturation with three different obturation technique at 6th hours
timeFrame: 6th hours.
measure: Analgesic intake comparison after root canal obturation with three different obturation technique at 12th hours
timeFrame: 12th hours
measure: Analgesic intake comparison after root canal obturation with three different obturation technique at 24th hours
timeFrame: 24th hours.
measure: Analgesic intake comparison after root canal obturation with three different obturation technique at 2nd days
timeFrame: 2nd days
measure: Analgesic intake comparison after root canal obturation with three different obturation technique at 3th days
timeFrame: 3th days
measure: Analgesic intake comparison after root canal obturation with three different obturation technique at 4th days
timeFrame: 4 th days
measure: Analgesic intake comparison after root canal obturation with three different obturation technique at 5th days
timeFrame: 5th days
measure: Analgesic intake comparison after root canal obturation with three different obturation technique at 6th days
timeFrame: 6th days
measure: Analgesic intake comparison after root canal obturation with three different obturation technique at 7th days
timeFrame: 7th days.
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Hicran Dönmez Özkan
Study officials:
affiliation: Adnan Menderes University, Faculty of Dentistry
name: Hicran Dönmez Özkan
role: STUDY_DIRECTOR
References:
citation: Alonso-Ezpeleta LO, Gasco-Garcia C, Castellanos-Cosano L, Martin-Gonzalez J, Lopez-Frias FJ, Segura-Egea JJ. Postoperative pain after one-visit root-canal treatment on teeth with vital pulps: comparison of three different obturation techniques. Med Oral Patol Oral Cir Bucal. 2012 Jul 1;17(4):e721-7. doi: 10.4317/medoral.17898.
citation: Su Y, Wang C, Ye L. Healing rate and post-obturation pain of single- versus multiple-visit endodontic treatment for infected root canals: a systematic review. J Endod. 2011 Feb;37(2):125-32. doi: 10.1016/j.joen.2010.09.005. Epub 2010 Nov 12.
citation: Graunaite I, Skucaite N, Lodiene G, Agentiene I, Machiulskiene V. Effect of Resin-based and Bioceramic Root Canal Sealers on Postoperative Pain: A Split-mouth Randomized Controlled Trial. J Endod. 2018 May;44(5):689-693. doi: 10.1016/j.joen.2018.02.010. Epub 2018 Mar 20.