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Clinical Trials/NCT06665152
NCT06665152CompletedNot Applicable

Comparison of Postoperative Pain After Root Canal Preparation With Reciprocal (WaveOne) Versus Continuous Rotary (ProTaper Gold) For Asymptomatic Irreversible Pulpitis

Ahmed Abdullah2 sites in 1 country74 target enrollmentStarted: January 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
74
Locations
2
Primary Endpoint
Post operative pain

Study Overview

Brief Summary

To compare the postoperative pain in patients undergoing root canal instrumentation with two different file systems, WaveOne and ProTaper systems.

Detailed Description

Endodontic postoperative pain is experienced after the procedure of root canal. It is defined as an unpleasant sensation, of varying degree, experienced by the patients. Depending upon the individual and other variable, the range of postoperative pain lies between 3% to 58%. Endodontic postoperative pain could occur due to various factors that can be microbial, injured pulp, chemical, or mechanical. Factors that influence pain following a root canal include the presence of preoperative pain, apical debris extrusion, intracanal interappointment dressing extrusion, presence of periapical pathosis, hyper occlusion, and irrigant extrusion.

Although apically extruded debris can be reduced through various means, it cannot be completely avoided. Thus, increasing the incidence of postoperative pain in patients. The debris produced during apical extrusion contains necrotic tissue, dental chips, microbes, pulp tissue, and canal irrigants. The infected debris may disturb the balance between the microbes and the immune system, leading to acute exacerbation.

Manual steel K files tend to produce more debris, causing a high risk of postoperative discomfort. Nickel-titanium rotary instruments powered by the engine have various advantages including; time-saving, preservation of root canal anatomy, and homogeneous preparation of the shape of the root canal. The debris produced by these instruments is potentially lesser than the manual files. Mainly because they have rotary action and they excavate the debris with the help of their flutes. Repeated irrigation along with the action of an engine-driven instrument, has the potential to decrease postoperative pain. WaveOne reciprocating file instruments have potential advantages including reduced fatigue, resistance to fracture, less debris extrusion, good shaping ability, no cross-contamination (single use), and reduced cost.

Relation between debris extrusion and postoperative care has not been established in any previous study. This study is aimed at comparing the use of ProTaper Universal and WaveOne system, for preparation of permanent human teeth during root canal procedure and their effect on postoperative pain.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Masking Description

The patients did not know which file system was used in their treatment. The investigator was also not disclosed the intervention's name; rather, a code name was given to them.

Outcomes accessor also did not know the exact name but was provided with a code name.

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patients with unremarkable/ noncontributory medical history
  • Healthy persons between the ages of 18 and 60 years
  • Maxillary and mandibular molar teeth diagnosed with symptomatic irreversible pulpitis.
  • Patients not having taken any medication for 6 hours before treatment
  • No allergies to the drugs or dental material being used in the treatment

Exclusion Criteria

  • Patients who had taken analgesics on anti-inflammatory drugs within the last 12 hours
  • Pregnant women and patients with immunocompromised health state
  • Patients having severe malocclusion associated with traumatic occlusion
  • Teeth with calcified canals
  • Teeth with periapical radiolucency
  • Teeth with root resorption
  • Teeth previously undergone root canal treatment

Outcomes

Primary Outcomes

Post operative pain

Time Frame: 6 hours - 72 hours

Document and compare post-operative pain after root canal treatment, after using two different motorized file systems with different mechanisms. The Visual Analog scale (VAS) would be used to assess the pain. The patients would be guided in detail about the VAS scoring system and mark pain according to the readings on VAS.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Ahmed Abdullah
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Ahmed Abdullah

Principal investigator

Armed Forces Institute of Dentistry, Pakistan

Study Sites (2)

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