Clinical trial NCT06665152: Comparison of Post-operative Pain After Using Different File Systems
Official title: Comparison of Postoperative Pain After Root Canal Preparation With Reciprocal (WaveOne) Versus Continuous Rotary (ProTaper Gold) For Asymptomatic Irreversible Pulpitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Armed Forces Institute of Dentistry, Pakistan
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of postoperative pain in two groups of patients, who underwent root canal treatment with two different file systems. total 74 patients divided into two groups and given different interventional treatment to monitor pain after treatment.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Post operative pain
timeFrame: 6 hours - 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: 28 MDC
state: Punjab
Study officials:
affiliation: CMH LMC IOD
name: Nadeem A Rana, BDS, FCPS
role: STUDY_DIRECTOR
References: