Clinical trial NCT03919318: Postoperative Pain After the Use of Different Root Canal Sealers
Official title: Effect of Two Different Calcium Silicate Based and One Epoxy Resin-based Root Canal Sealers on Postoperative Pain After Root Canal Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: postoperative pain
Endoseal MTA
Endosequence BC
AH Plus
Root canal filling
endodontic treatment
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluated the postoperative pain after the endodontic treatment using AH Plus, Endoseal MTA and EndoSequence BC sealers in root canal obturation.


Eligibility criteria: Inclusion Criteria:

* Participants between 18 - 60 years of age,
* Good oral hygiene,
* Have not taken any analgesics in the last day,
* Have not taken antibiotics in the last week,
* Patients diagnosed with asymptomatic irreversible pulpitis caused by deep carious lesion on the mandibular first or second molar teeth.
* A prolonged positive response to cold vitality tests,
* The presence of pulp, which is exposed during caries removing and bleeding with a dense and thick consistency.
* The periapical region was healthy in radiographic diagnosis.

Exclusion Criteria:

* Devital teeth that have no response to pulp test,
* The presence of advanced periodontal disease,
* Having a systemic disease that requires antibiotic prophylaxis,
* Radiographically more than 30° root inclination, presence of clear apex, presence of calcification, presence of root resorption,
* The need for root canal treatment which is mesial and/or distal neighbour of the tooth to be treated,
* The presence of a sinus tract in the relevant tooth region,
* Having systemic diseases that reduce immune system resistance,
* Participants with allergic sensitivity to materials and agents that should be used during the root canal treatment,
* Allergic sensitivity to local anesthetics,
* Pregnant participants or participants in the lactation period,
* Over preparation or over filling during treatment,
* Teeth which cannot be applied a rubber-dam,
* Teeth which was damaged enough to require coronal fiber post application,
* Sensitive to Ibuprofen based analgesics.

Primary outcomes:
measure: Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 6th hours.
timeFrame: 6th hours
measure: Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 12th hours.
timeFrame: 12th hours
measure: Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 24th hours.
timeFrame: 24th hours
measure: Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 48th hours.
timeFrame: 48th hours
measure: Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 3rd days.
timeFrame: 3rd days
measure: Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 4th days.
timeFrame: 4th days
measure: Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 5th days.
timeFrame: 5th days
measure: Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 6th days.
timeFrame: 6th days
measure: Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 7th days.
timeFrame: 7th days
Secondary outcomes:
measure: Analgesic intake comparison after root canal obturation with three different endodontic sealers at 6th hours.
timeFrame: 6th hours
measure: Analgesic intake comparison after root canal obturation with three different endodontic sealers at 12th hours.
timeFrame: 12th hours
measure: Analgesic intake comparison after root canal obturation with three different endodontic sealers at 24th hours.
timeFrame: 24th hours
measure: Analgesic intake comparison after root canal obturation with three different endodontic sealers at 48th hours.
timeFrame: 48th hours
measure: Analgesic intake comparison after root canal obturation with three different endodontic sealers at 3rd days.
timeFrame: 3rd days
measure: Analgesic intake comparison after root canal obturation with three different endodontic sealers at 4th days.
timeFrame: 4th days
measure: Analgesic intake comparison after root canal obturation with three different endodontic sealers at 5th days.
timeFrame: 5th days
measure: Analgesic intake comparison after root canal obturation with three different endodontic sealers at 6th days.
timeFrame: 6th days
measure: Analgesic intake comparison after root canal obturation with three different endodontic sealers at 7th days.
timeFrame: 7th days
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University, Faculty of Dentistry
state: İç Anadolu
Study officials:
affiliation: Erciyes University, Faculty of Dentistry
name: Tuğrul Aslan, PHD. Dr.
role: STUDY_DIRECTOR
References:
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.
citation: Atav Ates A, Dumani A, Yoldas O, Unal I. Post-obturation pain following the use of carrier-based system with AH Plus or iRoot SP sealers: a randomized controlled clinical trial. Clin Oral Investig. 2019 Jul;23(7):3053-3061. doi: 10.1007/s00784-018-2721-6. Epub 2018 Nov 5.