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Effect of Different Root Canal Disinfection Procedures on Postoperative Pain (EDRCD-PP)

C

Cumhuriyet University

Status

Completed

Conditions

Pain, Postoperative

Treatments

Procedure: Conventional Needle Irrigation
Procedure: KTP Laser Disinfection
Procedure: Passive Ultrasonic Irrigation
Procedure: Sonic Irrigation

Study type

Interventional

Funder types

Other

Identifiers

NCT07355816
2022-11/01

Details and patient eligibility

About

This clinical study evaluated the effects of different root canal disinfection procedures on postoperative pain. Patients requiring root canal treatment received one of several disinfection methods. Postoperative pain was assessed at 6,24, 48, 72 hours and on the 7th day using a standard pain scale. The aim of the study was to identify which method resulted in the least discomfort. Participation involved a single treatment session and short-term follow-up for pain measurement.

Enrollment

80 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

  • Systemically healthy individuals between the ages of 18 and 65,
  • Adequate mouth opening,
  • Asymptomatic devitaled mandibular premolar with a single root and single canal,
  • Negative response to cold and electric pulp tests and no bleeding at the pulp chamber opening,
  • Able to provide rubber dam isolation,
  • Presence of opposing teeth.

Exclusion criteria

  • Presence of mental or psychiatric disorders,
  • Allergic diseases,
  • Use of painkillers within 12 hours or antibiotics within 1 week before the procedure,
  • Swelling, palpation/percussion pain, or sinus tract before treatment,
  • Presence of a periodontal pocket greater than 3 mm in diameter on the involved tooth,
  • Presence of a periapical radiolucency greater than 5 mm in diameter associated with the involved tooth,
  • Initiation of root canal treatment,
  • Irreparable material loss, root fracture, or crack,
  • Severe mobility,
  • Open apex,
  • Severe root canal calcification,
  • Internal or external resorption,
  • Bruxism,
  • Complaints of pain elsewhere in the mouth or in a tooth,
  • Being pregnant or breastfeeding.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 4 patient groups

conventional needle irrigation
Experimental group
Description:
Conventional needle irrigation(CNI) Group: A total of 6 mL of 2.5% NaOCl was delivered in three cycles using a 31-gauge irrigation needle positioned 2 mm short of the working length. Each cycle lasted 20 seconds, followed by a 20-second waiting period. Subsequently, 2 mL of 17% Ethylenediaminetetraacetic acid(EDTA) (Imicryl Dental, Konya, Türkiye) was applied for 1 minute, followed by another 1-minute waiting period, and finally 2 mL of distilled water was used as the final rinse.
Treatment:
Procedure: Conventional Needle Irrigation
Passive Ultrasonic Irrigation Group
Experimental group
Description:
Passive ultrasonic irrigation(PUI) Group: Passive ultrasonic activation was performed with an ultrasonic device (Ultra X, Eighteeth, Changzhou, China) using a 20/.02 tip during the waiting periods used in the CNI group. The ultrasonic tip was positioned 2 mm short of the working length and activated vertically with 2-3 mm strokes without contacting the canal walls.
Treatment:
Procedure: Passive Ultrasonic Irrigation
Sonic Irrigation Group
Experimental group
Description:
Sonic irrigation(SI) Group: Sonic activation was performed using a polymer tip (Dentsply Tulsa Dental Specialties) loosely fitted into the canal and placed 2 mm short of the working length during the waiting periods used in the CNI group. The tip was activated by vertical in-and-out motion to induce sonic agitation.
Treatment:
Procedure: Sonic Irrigation
KTP Laser Disinfection Group
Experimental group
Description:
Potassium titanyl phosphate(KTP) Laser Group: In this group, after shaping was completed, the final irrigation procedure was carried out as in the CNI group. Following irrigation, the root canals were dried with sterile paper points at the working length. Then, KTP laser irradiation (SMARLITE D, DEKA laser system, Calenzano FI, Italy) was applied in a pulsed mode at 1.5 W power (Ton: 20 ms, Toff: 50 ms). A 200 µm fiber tip attached to the handpiece was inserted 1 mm short of the working length and moved coronally in a spiral motion for 5 seconds. After each 5-second irradiation, a 20-second interval was allowed, and the process was repeated five times. Laser safety protocols were strictly followed, and protective goggles were used by the operator, assistant, and patient.
Treatment:
Procedure: KTP Laser Disinfection

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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