An interventional study of Root canal treatment (AH Plus-NA) and Root canal treatment (AH Plus-EA) in Post Operative Pain and Apical Periodontitis, sponsored by Mustafa Kemal University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by Mustafa Kemal University · Not applicable, Interventional, and Treatment
Aim: This clinical study aims to compare post-operative pain after single-visit root canal treatment of teeth with asymptomatic apical periodontitis using epoxy-resin based AH Plus and calcium silicate based Endosequence BC sealers with or without sonic activation.
Materials and Methods: The study included 72 individuals having one first or second mandibular premolar tooth with asymptomatic apical periodontitis. They were randomly divided into 4 groups according to the root canal sealer (AH Plus or Endosequence BC) and activation protocol (sonic activation or non-activation) (n=18). Participants were ask to rate their post-operative pain intensity on a NRS scale as none, minimal, moderate, or severe after 24 h, 48 h, 72 h and 7 days following treatment. Patients were also asked to record the number of prescribed analgesic medication tablets (ibuprofen 400 mg) taken. The collected data were statistically analyzed at 0.05 significance level.
Root Canal Treatment After inferior alveolar nervus block anesthesia with 4% Articaine with 1:100,000 adrenaline, the tooth was isolated with a rubber dam. The access cavity was opened using high-speed diamond round burs under water cooling. The working length (WL) was set at 0.5 mm shorter than the 0.0 reading using a 15 K-type file and apex locator (Morita Root ZX, Japan) and checked with radiographs. The root canals were prepared with Resiproc (Resiproc, VDW, Munich, Germany) R25 and R40 files, respectively, at the WL using the crown down technique. A total of 20 mL of 2.5% sodium hypochlorite (NaOCl) was used with a 30-gauge needle (Max-i-Probe; Dentsply Sirona) during preparation. 5 mL of distilled water was left in the canal for 1 min to neutralize the effect of NaOCl, and then the root canals were irrigated with 3 ml of 17% ethylene diamine tetra acetic acid (EDTA). EDTA was activated for 3 × 20s with the EA 25/04 tip 2 mm shorter than the WL. The EA tip was used with 2-4 mm vertical strokes. The root canals were irrigated with 5 mL distilled water and dried with paper points.
The subjects were divided into four groups for root filling. Randomization was performed using online software (www.randomizer.org) with a four-block-sized block randomization technique to ensure even distribution between the groups (allocation ratio 1:1:1:1). A co-investigator managed the allocation and reported the allocated treatment procedure to the operator. The operator could not be blinded due to the different stages of the treatment protocols. The patients were blinded to the chosen root canal sealer and activation protocol.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 120 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
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Exclusion Criteria:
AH Plus was mixed according to the manufacturer's instructions. The R40 gutta-percha (VDW) was coated with the sealer and inserted into the canal, and the root canals were filled using the single cone technique (SCT). The sealer was not activated.
Procedure: Root canal treatment (AH Plus-NA)
An EA 25/04 tip was coated with AH Plus and activated in the root canals for 10 seconds. Then, the R40 gutta-percha was coated with the sealer and inserted into the canal, and the root canals were filled using SCT.
Procedure: Root canal treatment (AH Plus-EA)
The ready-to-use EndoSequence BC was injected into the root canals and no activation was performed. Then, the R40 gutta-percha was inserted into the canali and the root canals were filled using SCT.
Procedure: Root canal treatment (BC-NA)
EndoSequence BC was injected into the root canals. An EA 25/04 tip was inserted 2 mm beyond the WL and activated for 10 s. Then, the R40 gutta-percha was inserted into the canal and the root canals were filled using SCT.
Procedure: Root canal treatment (BC-EA)
Root canal treatment procedures explained in arm descriptions.
Root canal treatment procedures explained in arm descriptions.
Root canal treatment procedures explained in arm descriptions.
Root canal treatment procedures explained in arm descriptions.
post operative pain
All participants were given a questionnaire based on a 0-10 numeric rating scale (NRS), with 0 indicating no pain and 10 indicating the worst pain. Patients recorded their pain on days 1, 2, 3 and 7 after treatment. Pain intensity was rated into 4 categories using the NRS. None: (NRS 0); Mild (NRS 1-3); Moderate (NRS 4-7); Severe (NRS 8-10).
Time frame: 1 week
Plan to share: No
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Mustafa Kemal University