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NCT Number: NCT06129643

"Postoperative Pain Following Laser-Assisted Root Canal Treatment: A Randomized Clinical Trial"

The aim of this study is to evaluate in vivo the post operative pain after laser root canal treatment in necrotic teeth in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in post operative pain between conventional irrigation and the two types of lasers used.

Forty-five patients are equally divided into 3 separate groups :

* Group A (Conventional): 2.5% NaOCL and 17% EDTA. * Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination * Group C(Combined): saline along with 17% EDTA and diode laser combination Each patient is given pain scale chart Numeric Rating Scale (NRS) to record his/her pain level before any endodontic treatment. All data will be collected, tabulated, summarized, and statistically analyzed.

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Key information

Conditions

Pulp Necroses Apical Periodontitis Dental Pulp Diseases Dental Pulp Necrosis Jaw Diseases Mouth Diseases Necrosis Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Postoperative Complications Pulp Disease, Dental Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ain Shams University

Cairo, Abbassia, 11566, Egypt

About this study

Postoperative pain is a common complication following conventional endodontic treatment. According to a systematic review, the frequency of endodontic postoperative pain is between 3% and 58% of patients.Postoperative pain is attributed to chemical, mechanical and microbiological factors.

Residual microorganisms remaining due to the complexity of the root canal system and the limited penetration capability of conventional irrigants are directly responsible for Post operative pain The aim of this study is to evaluate in vivo the post operative pain after laser root canal treatment in necrotic teeth in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in post operative pain between conventional irrigation and the two types of lasers used.

Forty-five patients are equally divided into 3 separate groups :

  • Group A (Conventional): 2.5% NaOCL and 17% EDTA.
  • Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination
  • Group C(Combined): saline along with 17% EDTA and diode laser combination Each patient will be given pain scale chart (NRS scale) to record his/her pain level before any endodontic treatment. After disinfection, local anesthetic, tooth isolation, access cavity preparation and final obturation. Patients are asked to mark on a numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity at 6, 12, 24, 48, 72 hours, and 7 days after the procedure All data will be collected, tabulated, summarized, and statistically analyzed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who had asymptomatic, single-rooted maxillary anterior teeth with necrotic pulp and periapical lesion with a periapical index score of 3 or 4
  • Patients complaining of no pain and without fistulous tract
  • Closed apex.
  • Acceptance to participate in the study.

Exclusion criteria

  • Antibiotic use within the last month, anti-inflammatory analgesic use within the last 5 d, systemic diseases or allergic reactions, calcified canals, root resorption, previous root canal treatment.
  • Periodontal diseases, presence of swelling or fistulous tract.
  • Vulnerable group including pregnant females, mentally or physically disabled individuals. - Technical difficulties during root canal treatment such as; curved roots, broken files, over instrumentation, overfilling or incomplete filling.

Treatment and study plan

Conventional group

Drug

conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA

Other names: (NaOCl/EDTA)

Dual laser group

Device

Er,Cr:YSGG intracanal laser irradiation to remove smear layer followed by diode laser for disinfection

Other names: (Er,Cr:YSGG/Diode)

Combined group

Combination Product

17% EDTA was used to remove smear layer followed by diode laser for disinfection

Other names: (EDTA/Diode)

Primary outcomes

  1. Postoperative pain assessment

    Time frame: Measure changes in post-operative pain 6 hours after intervention in the three groups using NRS

    Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain".

    • Pain level assigned to one of 4 categorical scores:
    • No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).

  2. Postoperative pain assessment

    Time frame: Measure changes in post-operative pain 12 hours after intervention in the three groups using NRS

    Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain".

    • Pain level assigned to one of 4 categorical scores:
    • No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).

  3. Postoperative pain assessment

    Time frame: Measure changes in post-operative pain 24 hours after intervention in the three groups using NRS

    Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain".

    • Pain level assigned to one of 4 categorical scores:
    • No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).

  4. Postoperative pain assessment

    Time frame: Measure changes in post-operative pain 48 hours after intervention in the three groups using NRS

    Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain".

    • Pain level assigned to one of 4 categorical scores:
    • No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).

  5. Postoperative pain assessment

    Time frame: Measure changes in post-operative pain 72 hours after intervention in the three groups using NRS

    Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain".

    • Pain level assigned to one of 4 categorical scores:
    • No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).

  6. Postoperative pain assessment

    Time frame: Measure changes in post-operative pain up to 7 days after intervention in the three groups using NRS

    Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain".

    • Pain level assigned to one of 4 categorical scores:
    • No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Collaborators

  • Ain Shams University

Registry information

Official study title

"Postoperative Pain Following Laser-Assisted Root Canal Treatment of Necrotic Teeth With Apical Periodontitis: A Randomized Clinical Trial"

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Nov 13, 2023
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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