Postoperative Pain After Using Er,Cr,YSGG Lazer Irradiation During Root Canal Treatment

NCT03783520 | Completed

• 1 other identifier: Cukurova Endodontics
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief Summary

Irrigation with sodium hypochlorite (NaOCl) during chemo-mechanic preparation for effective root canal disinfection is a standard protocol in root canal treatment. NaOCl is an alkali irrigant with pH 11.0 -12.0. Nearby its high antimicrobial efficacy, cytotoxic features make it questionable when it comes contact with periradicular tissues. Several irrigation materials were investigated less cytotoxic, more or equal antimicrobial to avoid such adverse effects. Calcium hypochlorite, chlorhexidine, chitosan and antibiotics are some of the chemicals tested. Laser is not a chemical but its action may show antibacterial effect. Studies showed that Er,Cr:YSGG laser is strongly antibacterial against Enterococcus faecalis biofilm. This antibacterial effect were frequently obtained with laser activated irrigation (LAI) or photon-induced photoacoustic streaming (PIPS) in the literature. The aim of this study was to evaluate whether disinfection procedure with laser provides more or less benefit in terms of postoperative pain when compared with the conventional NaOCl irrigation method.

Conditions

Postoperative Pain

Keywords

root canal treatment; intracanal irrigation; Laser

Outcome Measures

Primary Outcomes (1)

• Evaluation of Postoperative pain

  Postoperative pain evaluation with verbal analog scale after root canal treatment. Patients signed as 0: no pain; 1: mild pain, analgesic not required; 2: moderate pain, analgesic required; 3: severe pain, analgesic has no effect in relieving the pain. The data were collected and statistically analysed using by the numerical data. In this study, "0" and "1" scores are considered as better outcome. Patients who signed these scores didn't need to use analgesics. The worst outcome is considered as the patients signed "3". Each scale range for each time interval evaluated as count of patient and presented as percentage. Scale ranges are not summed.

  0-24 hours after root canal treatment

Study Arms (2)

Er,Cr:YSGG Laser

EXPERIMENTAL

In laser group, each root canal was dried with paper points and then Er,Cr:YSGG (Biolase™, Waterlase™, San Clemente, CA, USA) was used for intracanal disinfection with the following parameters: panel output power of 0,75 W, pulse frequency of 20 Hz, and 1% water pressure to 10% air pressure ratio laser with RFT3 tips (415 µm diameter radial firing tip RFT3 Endolase, Biolase Technology, Inc; calibration factor of 0.85). The fiber was placed at 1mm short of the WL. Irradiation was delivered along the entire length of the root canal with helicoradial movements, 1mm per seconds in speed. This procedure was repeated three times and kept for 20 seconds between each irradiation.

Device: Er,Cr:YSGG Laser

Sodium hypochlorite

ACTIVE COMPARATOR

In control group, each canal were irrigated with 6 ml of 2,5% NaOCl. For the final irrigation, 5 ml of sterile saline were used. During irrigation, needle was inserted 1 mm short of the WL.

Other: Sodium hypochlorite

Interventions

Er,Cr:YSGG Laser DEVICE

Er,Cr:YSGG Laser is used for disinfection of the root canals.

Er,Cr:YSGG Laser

Sodium hypochlorite OTHER

Sodium hypochlorite is used for disinfection of the root canals

Sodium hypochlorite

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• )Single-rooted, maxillary and mandibular incisors, canines or premolars that were asymptomatic (no preoperative pain, swelling or acute endodontic or periodontal abscess). 2)Nonvital pulps and did not respond to cold testing.
• )People had no systemic diseases or allergies to local anesthetic agents . 4)People had not received any endodontic treatment previously. 5)People had no radiographic evidence of periapical bone loss.

You may not qualify if:

• Pregnant and breastfeeding women
• Patients taking analgesic, anti-inflammatory, or antibiotic medications during seven days prior to beginning of treatment.

Sponsors & Collaborators

• Cukurova University: lead

Related Publications (4)

• Arias A, de la Macorra JC, Hidalgo JJ, Azabal M. Predictive models of pain following root canal treatment: a prospective clinical study. Int Endod J. 2013 Aug;46(8):784-93. doi: 10.1111/iej.12059. Epub 2013 Feb 12.

  PMID: 23402273 BACKGROUND

• Dewsnup N, Pileggi R, Haddix J, Nair U, Walker C, Varella CH. Comparison of bacterial reduction in straight and curved canals using erbium, chromium:yttrium-scandium-gallium-garnet laser treatment versus a traditional irrigation technique with sodium hypochlorite. J Endod. 2010 Apr;36(4):725-8. doi: 10.1016/j.joen.2009.11.017. Epub 2010 Feb 6.

  PMID: 20307752 BACKGROUND

• Figini L, Lodi G, Gorni F, Gagliani M. Single versus multiple visits for endodontic treatment of permanent teeth: a Cochrane systematic review. J Endod. 2008 Sep;34(9):1041-7. doi: 10.1016/j.joen.2008.06.009.

  PMID: 18718362 BACKGROUND

• Christo JE, Zilm PS, Sullivan T, Cathro PR. Efficacy of low concentrations of sodium hypochlorite and low-powered Er,Cr:YSGG laser activated irrigation against an Enterococcus faecalis biofilm. Int Endod J. 2016 Mar;49(3):279-86. doi: 10.1111/iej.12447. Epub 2015 Apr 1.

  PMID: 25772335 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Dentist

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 21, 2018
• Study Start: November 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 21, 2020

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share