Effect of Cryotherapy and LLLT on Postoperative Pain After Root Canal Treatment

NCT05476445 | Completed

• 1 other identifier: 28.04.2022/416
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effect of low-level laser therapy (LLLT) and intracanal cryotherapy applications on postoperative pain in endodontic interventions of primary molar teeth with apical periodontitis. 75 patients were randomly assigned to the control, low-level laser and cryotherapy groups.Root canal treatments were performed in a single session. The pain intensity felt by the patients on the preoperative and postoperative 1st, 3rd, 5th and 7th days were recorded using the Wong Baker visual pain scale. Preoperative and postoperative 7th day percussion sensitivity was recorded using the VAS (visual analog scale) scale. The pain scores of the groups at different times after the procedure were compared. Statistical analysis of the data was performed at the 0.05 significance level.

Conditions

Root Canal Infection; Pain, Postoperative; Cryotherapy Effect; Laser; Pulpitis

Keywords

cryotherapy; LLLT; postoperative pain; pulpectomy; primary teeth

Outcome Measures

Primary Outcomes (7)

• Wong Baker wong baker faces pain rating scale

  Patient's current pain. Scores between 0 to 5. Higher score means worse outcome.

  preoperative

• Wong Baker wong baker faces pain rating scale

  Patient's current pain. Scores between 0 to 5. Higher score means worse outcome.

  postoperative (1st day)

• Wong Baker wong baker faces pain rating scale

  Patient's current pain. Scores between 0 to 5. Higher score means worse outcome.

  postoperative (3rd day)

• Wong Baker wong baker faces pain rating scale

  Patient's current pain. Scores between 0 to 5. Higher score means worse outcome.

  postoperative (5th day)

• Wong Baker wong baker faces pain rating scale

  Patient's current pain. Scores between 0 to 5. Higher score means worse outcome.

  postoperative (7th day)

• Visual Analog Scale (VAS)

  Percussion pain of tooth. Scores between 0 to 10. Higher score means worse outcome.

  preoperative

• Visual Analog Scale (VAS)

  Percussion pain of tooth. Scores between 0 to 10. Higher score means worse outcome.

  postoperative 7th day

Study Arms (3)

Control

ACTIVE COMPARATOR

After the carious tissue was removed and the endodontic cavity was opened, isolation was provided with a rubber-dam. After the canal length was determined with the Apex locater, the canals were prepared using Ni-Ti endodontic rotary instrument files at the torque value recommended by the manufacturer in an endodontic motor. Irrigation needles were kept 4-5 mm shorter than the working length, and irrigation of the channels was performed. A total of 5 ml of 1% NaOCl was washed for each canal, with 2 ml between each pecking movement of the files. The final washing of the channels was carried out using 5 ml of saline at room temperature.After the canals were dried with the help of a paper cone, the canals were filled by injecting iodoform and calcium hydroxide-containing canals. Then the restoration was completed with compomer.

Procedure: Control

Low level laser therapy

EXPERIMENTAL

After the carious tissue was removed and the endodontic cavity was opened, isolation was provided with a rubber-dam. After the canal length was determined with the Apex locater, the canals were prepared using Ni-Ti endodontic rotary instrument files at the torque value recommended by the manufacturer in an endodontic motor. A total of 5 ml of 1% NaOCl was washed for each canal, with 2 ml between each pecking movement of the files. The final washing of the channels was carried out using 5 ml of saline at room temperature.After the canals were dried with the help of a paper cone, the canals were filled by injecting iodoform and calcium hydroxide-containing canals. Then the restoration was completed with compomer. Following the restoration in the LLLT group, the diode laser was activated in biostimulation mode for a total of 1 minute, 30 seconds in the buccal and lingual/palatal regions at the root apex.

Procedure: Laser

Cryotherapy

EXPERIMENTAL

After the carious tissue was removed and the endodontic cavity was opened, isolation was provided with a rubber-dam. After the canal length was determined with the Apex locater, the canals were prepared using Ni-Ti endodontic rotary instrument files at the torque value recommended by the manufacturer in an endodontic motor. Irrigation needles were kept 4-5 mm shorter than the working length, and irrigation of the channels was performed. A total of 5 ml of 1% NaOCl was washed for each canal, with 2 ml between each pecking movement of the files. The final washing of the channels was carried out using 5 ml of saline at room temperature. After the last wash, in the cryotherapy group, unlike the first two groups, each canal was washed with 5 ml of 2°C cold physiological saline for 5 minutes. After the canals were dried with the help of a paper cone, the canals were filled by injecting iodoform and calcium hydroxide-containing canals. Then the restoration was completed with compomer.

Procedure: Cryotherapy

Interventions

Control PROCEDURE

Root canal treatment

Control

Laser PROCEDURE

Root canal treatment+Laser application

Low level laser therapy

Cryotherapy PROCEDURE

Root canal treatment + Cryotherapy application

Cryotherapy

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The informed consent form is signed by the parent,
• The patient is between the ages of 6-9,
• The patient is cooperative (Frankl scale category 3 and 4),
• Having a history of spontaneous pain in primary molar teeth,
• Percussion sensitivity value before treatment is 5 or above 5 on the VAS pain scale,
• Presence of a primary molar tooth with acute or chronic infection in its pulp,
• When the crown pulp of primary molar teeth is removed, the bleeding in the root pulp does not stop or does not exist within 5 minutes,
• Primary molars that can be isolated with rubber-dam,

You may not qualify if:

• Patients with any systemic disease (including conditions requiring antibiotic prophylaxis) or psychiatric problems,
• Patients who used any analgesic, anti-inflammatory or antibiotic in the last 1 week in the last 24 hours before root canal treatment,
• Patients who are allergic to the materials used in the treatment,
• Primary molar teeth with excessive crown destruction that cannot be restored,
• Primary molar teeth with bone loss between roots exceeding 1/3,
• Having previously applied root canal treatment or amputation treatment in the relevant tooth,
• Presence of internal/external and physiological root resorption in the relevant tooth,
• Teeth with root fracture, ankylosis or mobility (Miller mobility classification 3 and 4),
• Teeth with excessive crown destruction that cannot be restored or a rubber-dam can be placed,

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University Faculty of Dentistry

Erzurum, 25050, Turkey (Türkiye)

Location

Related Publications (4)

• Gundogdu EC, Arslan H. Effects of Various Cryotherapy Applications on Postoperative Pain in Molar Teeth with Symptomatic Apical Periodontitis: A Preliminary Randomized Prospective Clinical Trial. J Endod. 2018 Mar;44(3):349-354. doi: 10.1016/j.joen.2017.11.002. Epub 2018 Feb 3.

  PMID: 29398090 BACKGROUND

• Al-Nahlawi T, Hatab TA, Alrazak MA, Al-Abdullah A. Effect of Intracanal Cryotherapy and Negative Irrigation Technique on Postendodontic Pain. J Contemp Dent Pract. 2016 Dec 1;17(12):990-996.

  PMID: 27965485 BACKGROUND

• Lopes LPB, Herkrath FJ, Vianna ECB, Gualberto Junior EC, Marques AAF, Sponchiado Junior EC. Effect of photobiomodulation therapy on postoperative pain after endodontic treatment: a randomized, controlled, clinical study. Clin Oral Investig. 2019 Jan;23(1):285-292. doi: 10.1007/s00784-018-2435-9. Epub 2018 Apr 16.

  PMID: 29658070 BACKGROUND

• Arslan H, Doganay E, Karatas E, Unlu MA, Ahmed HMA. Effect of Low-level Laser Therapy on Postoperative Pain after Root Canal Retreatment: A Preliminary Placebo-controlled, Triple-blind, Randomized Clinical Trial. J Endod. 2017 Nov;43(11):1765-1769. doi: 10.1016/j.joen.2017.06.028. Epub 2017 Sep 28.

  PMID: 28967495 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Pulpitis

Interventions

Lasers; Cryotherapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Therapeutics

Study Officials

• Fatih Şengül, Phd

  Atatürk Uni. Faculty of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and the assessor don't know the study group names.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: After the canal length was determined with the Apex locater, the canals were prepared using Ni-Ti endodontic rotary instrument files. Irrigation needles were kept 4-5 mm shorter than the working length, and irrigation of the channels was performed. A total of 5 ml of 1% NaOCl was washed for each canal, with 2 ml between each pecking movement of the files. The final washing of the channels was carried out using 5 ml of saline at room temperature. After the last wash, in the cryotherapy group, unlike the first two groups, each canal was washed with 5 ml of 2°C cold physiological saline for 5 minutes. After the canals were dried with the help of a paper cone, the canals were filled by injecting iodoform and calcium hydroxide-containing canals. Then the restoration was completed with compomer. Following the restoration in the LLLT group, the diode laser was activated in biostimulation mode for a total of 1 minute, 30 seconds in the buccal and lingual/palatal regions at the root apex.

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 27, 2022
• Study Start: May 2, 2022
• Primary Completion: June 3, 2022
• Study Completion: June 17, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)