Effect of Low-level Laser Therapy Versus Calcium Hydroxide Intracanal Medication on Postoperative Pain and Substance P Levels in Patients With Symptomatic Apical Periodontitis

NCT04594317 | Unknown

• 1 other identifier: ENDO 3/3/5
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

a randomized clinical study to compare the effect of using low level laser therapy versus calcium hydroxide intra-canal medication on:

• Incidence and intensity of postoperative pain in patients with symptomatic apical periodontitis.
• The intensity of postoperative percussion pain in patients with symptomatic apical periodontitis
• The total amount of substance P and Interleukin 8 in periapical fluids one week post instrumentation.

Conditions

Postoperative Pain; Apical Periodontitis

Keywords

low level laser therapy; calcium hydroxide; postoperative pain; biomarker; substance P; interleukin 8

Outcome Measures

Primary Outcomes (1)

• incidence of postoperative pain

  incidence of postoperative pain will be recorded in pain chart

  24 hours

Secondary Outcomes (1)

• intensity of postoperative pain: modified visual analogue scale

  48 hours

Study Arms (2)

low level laser therapy

EXPERIMENTAL

970 ± 15-nm diode laser (Biolase Epic X, Biolase, Irvine, California, USA)will be activated at 0.5 W and 10 Hz at a distance of approximately 10 mm to the tissue around the apex of the root. A circular movement will be performed during application. Pulse duration will be 0.5 s, and pulse pause will be 50%. Total application time will be30 s for the tooth. For this application, a 200-μm optical tip will be used.

Device: low level laser therapy

Calcium hydroxide intracanal medication

ACTIVE COMPARATOR

calcium hydroxide paste (Metapaste, Meta Biomed Co., Ltd, Korea) will be inserted in the canal using disposable plastic tip and placed at a distance 1 or 2 mm less than the working length.

Device: low level laser therapy

Interventions

low level laser therapy DEVICE

buccal application of diode laser on non-contact mode

Calcium hydroxide intracanal medication; low level laser therapy

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
• Age between 25-50 years old.
• Males \& Females.
• Single canaled teeth:
• Diagnosed clinically with symptomatic apical periodontitis.
• Widening in the periodontal membrane space or with small sized periapical radiolucency
• Presence of pain with percussion and preoperative percussion pain level will be evaluated and recorded using modified visual analog scale (VAS).
• Patients' acceptance to participate in the trial.
• Patients who can understand pain scale and can sign the informed consent

You may not qualify if:

• Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients have shown higher incidence of pain and lower healing rate.
• Pregnant women: Avoid radiation exposure, anesthesia, and medication.
• If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively might alter their pain perception.
• Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation.
• Teeth that shows association with acute periapical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.
• Greater than grade I mobility or pocket depth greater than 5mm. Need special surgical and/or periodontal therapy.
• No restorability: Hopeless tooth.
• Immature teeth.
• Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Pain, Postoperative; Periapical Periodontitis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will be blinded to the study hypothesis as to which intervention is expected to be better.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized parallel clinical trial

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 20, 2020
• Study Start: February 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: January 26, 2021

Record last verified: 2021-01