Evaluating Postoperative Pain and Antibacterial Effect of Ultrasonic and 980 nm Diode Laser Combination

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-35
SponsorAl-Azhar University

About this trial

This study is a parallel randomized controlled clinical trial that was designed and interpreted according to Preferred Reporting Items for Randomized Trial in Endodontics (PRIRATE) 2020 guidelines. Patients of age range between 20 and 35 years old from the outpatient clinic of Endodontic Department, Faculty of Dental Medicine for Girls, Al-Azhar University will participate in this study. These patients have single rooted teeth with necrotic pulp and periapical radiolucency. Patients will be informed about all the study's procedures. They will be included in the study after fulfilling the inclusion criteria and sign an informed consent.Inclusion Criteria:

* Patients have mature teeth with closed apex. * Single rooted teeth with root canal form type I. * Asymptomatic. * Have Periapical radiolucency with diameter up to 5 mm. * Restorable teeth.

Exclusion Criteria:

* Patients with symptomatic apical periodontitis. * Systemic disease. * Physical or mental disability. * Root fracture and tooth mobility.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients have mature teeth with closed apex.

Single-rooted teeth with root canal form type I.

Asymptomatic.

Have periapical radiolucency with a diameter of up to 5 mm.

Disqualifiers

Patients with symptomatic apical periodontitis.

Systemic disease.

Physical or mental disability.

Root fracture and tooth mobility.

Trial design

Design model

Parallel

Treatments tested in this trial

  • diode laser

    Device

    980 nm diode laser with optical fiber 200 µm (Lite medics, Italy) and power setting 1.2 watt in pulsed mode. The irradiation protocol will be a 5 sec. irradiation followed by a 10 sec. rest, which constituted one lasing cycle. The lasing cycle will be performed four times for each tooth.

  • conventional irrigation

    Other intervention

    After each file use, the root canal will be irrigated with 5ml of freshly prepared 2.5% sodium hypochlorite (NaOCl) solution (Alex. Deteregents and Chemical Co., Egypt) for 1 minute using a 31-gauge Navi-Tip flexible irrigating needle (Navi-Tip, Ultradent product, South Jourdan, UT). 5 ml of 17% EDTA (Colgate Oral Care Company, Waverly, Australia) for 1 min will be used for smear layer removal. 5 ml of saline solutio

  • Diode laser

    Device

    980 nm diode laser with optical fiber 200 µm (Lite medics, Italy) and power setting 1.2 watt in pulsed mode. The irradiation protocol will be a 5 sec. irradiation followed by a 10 sec. rest, which constituted one lasing cycle. The lasing cycle will be performed four times for each tooth.

  • Ultrasonic

    Device

    The needle will be operated using Satelec P5 Piezoelectric Ultrasonic Unit (Acteon, Mount Laurel, NJ, USA.) at power setting of 5. The stopper on the PiezoFlow needle will be set 1 mm short of binding in the canals, but not more than 75% of the WL. A syringe containing 5 mL of 2.5% NaOCl will be attached to the Piezoflow activation needle and the inactive needle will be inserted in the canal, and irrigant flow will be started before activation. During activation, the needle will be moved up and down passively in the canal

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Group I (conventional group)Experimental treatment 1 intervention
Group B: Group II (Diode laser group)Experimental treatment 1 intervention
Group C: Group III (Ultrasonic group)Experimental treatment 1 intervention
Group D: Group IV Ultrasonic+DiodeExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Postoperative pain evaluation

Postoperative pain will be recorded using numerical rating scale (NRS) with minimum value 0 and maximum value 10 (worst pain).

Time frame
after 24,48 and 72hours of the treatment

Secondary outcomes

1

Microbiological analysis

Microbiological analysis of samples (S1\&S2) will be performed to evaluate the percentage of reduction in the number of Colony Forming Units (CFU) of aerobic and anaerobic bacteria.

Time frame
24,48 hours

Other outcomes

Sponsors and contacts

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