Postoperative Pain After İntracanal Procedures

NCT04892355 | Unknown FDA Device

• 1 other identifier: AfyonkarahisarHSU
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim: The aim of this study is to investigate the effects of different irrigation activation systems on pain after endodontic treatment in molar teeth with irreversible pulpitis.Post-operative pain values of the participants will be recorded and evaluated with the VAS scale. Postoperative pain values of the techniques will be compared with statistical evaluation.

Conditions

Endodontically Treated Teeth

Keywords

EDDY; EndoActivatör; Xp-endo Finisher; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain After İntracanal Procedures Based On Different İrrigation Activation Tecniques: A Randomized, Clinical Trial

  Preoperative pain of the patients before the treatment was recorded with the VAS scale. Pain levels were classified as 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-10: severe pain .After the treatment of the patients, a pain assessment form was given to the patient in order to evaluate the postoperative pain. Patients were asked to mark their pain levels on the VAS scale. The marking procedure was taught to the patients by a blinded researcher from the groups. When the patients came to the control appointment, VAS scales were collected and the data were analyzed.

  one week(7 days)

Study Arms (4)

Conventional Syringe Irrigation Group

EXPERIMENTAL

During the final irrigation procedure, a 30 - G side vented needle was placed 2 mm shorter than the working length and was applied without agitation. 5 mL of 2.5% NaOCl was applied for 1 minute for each channel. Each canal was then washed with 2 mL of 17% EDTA for 1 minute.

Device: Root canal irrigation

Xp Endo Finisher Group

EXPERIMENTAL

Xp Endo Finisher file was used with VDW Silver (VDW) endomotor at 800 rpm speed and 1 Ncm torque according to the manufacturer's instructions. The Xp Endo Finisher file was placed in the canal, 2 mm shorter than the working length, and was used with slow movements of 7-8 mm amplitude in the canal during activation. 5 mL of 2.5% NaOCl was applied for 1 minute for each channel. Each canal was then washed with 2 mL of 17% EDTA for 1 minute.

Device: Root canal irrigation

EDDY Group

EXPERIMENTAL

An EDDY tip of size 25/04 was used for sonic activation. The EDDY was placed in the duct 2 mm shorter than the working length and the activation process was performed with slow movements with an amplitude of 2-4 mm. In the irrigation process, 5 mL of 2.5% NaOCI was applied for 1 minute for each channel. Each canal was then washed with 2 mL of 17% EDTA for 1 minute.

Device: Root canal irrigation

Endoactivator Group

EXPERIMENTAL

Medium Endoactivator tip of 25 / .04 size was used for irrigation activation. Medium type was placed in the canal 2 mm shorter than the working length and activation was performed by making short strokes of 2-3 mm. 5 mL of 2.5% NaOCl was applied for 1 minute for each channel. Each canal was then washed with 2 mL of 17% EDTA for 1 minute.

Device: Root canal irrigation

Interventions

Root canal irrigation DEVICE

Devices used during root canal irrigation

Also known as: EndoActivator (Dentsply Tulsa Dental Specialties, Tulsa, OK)-XP-endo Finisher (XPF; FKG Dentaire SA, La Chaux-de-Fonds, Switzerland)- EDDY (EDDY; VDW, Munich, Germany)-

Conventional Syringe Irrigation Group; EDDY Group; Endoactivator Group; Xp Endo Finisher Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: No gender discrimination will be applied in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy patients ranging between 18 and 60 years in age
• Patients that experienced moderate-to-severe pain represented on a visual analogue scale (VAS)
• Maxillar and Mandibular molar teeth were diagnosed with symptomatic irreversible pulpitis

You may not qualify if:

• Any systemic disease and pregnancy in the patient
• Having used analgesic-anti-inflammatory in the last 12 hours and cortisone for the last 6 months
• The patient has bruxism
• Teeth with severe damage
• Teeth with calcified canals
• Teeth with pain to percussion
• Teeth with periapical radiolucency
• Teeth with root resorption
• Teeth with an immature / open apex
• Teeth with previous RCT

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

MeSH Terms

Conditions

Tooth, Nonvital; Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• yahya güven

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yahya güven

CONTACT

05314599583; yahyaguven52@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr. Yahya GÜVEN

Model Details: 4-group clinical trial

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 19, 2021
• Study Start: August 6, 2022
• Primary Completion: October 6, 2022
• Study Completion: November 6, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-02