ClinicalTrials.Veeva

Menu

Comparison of Postoperative Pain After Root Canal Treatment With Rotary vs Reciprocating Systems (Post op pain)

A

Armed Forces Institute of Dentistry, Pakistan

Status

Completed

Conditions

Post Operative Pain

Treatments

Device: Hyflex EDM system
Device: Reciproc VDW system

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

To compare the postoperative pain in patients undergoing root canal instrumentation with two different file systems, Hyflex EDM and Reciproc VDW.

Full description

Endodontic postoperative pain is experienced after the procedure of the root canal. It is defined as an unpleasant sensation, of varying degrees, 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 root canal shape. The debris produced by these instruments is potentially lesser than the manual files. Mainly because they have rotary action and 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. Reciproc VDW 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.

No previous study has established a relationship between debris extrusion and postoperative care. This study aims to compare the use of the Hyflex EDM and Reciproc VDW systems for preparing permanent human teeth during root canal procedures and their effect on postoperative pain.

Enrollment

80 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 2 patient groups

Hyflex Group
Active Comparator group
Description:
These patients underwent root canal treatment due to pain in their molar teeth. The file system used in this arm was Hyflex EDM (Coltene), a rotary file system that moves in a complete 360° rotation and prepares a root canal.
Treatment:
Device: Hyflex EDM system
Recriproc Group
Active Comparator group
Description:
These patients underwent root canal treatment due to pain in their molar teeth. The file system used in this arm was Reciproc (VDW), a reciprocating file system that moves in 130° anticlockwise and 50° clockwise motion and prepares a root canal.
Treatment:
Device: Reciproc VDW system

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems