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NCT03096587 Clinical Trial

Effect Of XP Endo Finisher Versus Ultrasonic Activated Irrigation On Post-operative Pain In Endodontic Treatment of Symptomatic Irreversible Pulpitis

Symptomatic Irreversible Pulpitis Clinical Trial

— RCT  

Official title:
Effect Of Using XP Endo Finisher Versus Ultrasonic Activated Irrigation On Post-operative Pain In Single Visit Endodontic Treatment of Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03096587
Other study ID # CEBC-CU-2017-03-19
Secondary ID
Status Recruiting
Phase N/A
First received March 25, 2017
Last updated August 21, 2017
Start date April 15, 2017
Est. completion date April 2018

Study information
Verified date August 2017
Source Cairo University
Contact Nouran A Hany, BDS
Phone +2 01223626996
Email nouranhany11@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Recruited patients with symptomatic irreversible pulpitis are assigned to interventional (XP Endo Finisher file) and control group(ultrasonic activated irrigation) to undergo single visit endodontic treatment and record postoperative pain afterwards.

Description:

The investigator will recruit patients from the clinic of endodontics in faculty of oral and dental medicine, Cairo university.

The patients who are found eligible to the criteria, will be randomly assigned to either the control group (ultrasonic activated irrigation )or to the intervention group( XP Endo-Finisher file). Endodontic treatment will be done in single visit.

After the visit, patients will be asked to record post operative pain by NRS (Numerical Rate Scale)in a given sheet.

Recruitment information / eligibility
Status Recruiting
Enrollment 44
Est. completion date April 2018
Est. primary completion date April 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 45 Years
Eligibility Inclusion Criteria:

1. Medically- free of any systemic disease

2. Male or female

3. Patients with age range 25-45

4. Symptomatic irreversible pulpitis in single rooted single canal teeth without apical periodontitis.

5. Teeth with mature root

6. Restorable teeth

7. Teeth without calcified root canals

8. Teeth without root caries

9. Teeth without internal or external root resorption

10. Teeth with no sign of crack formation

11. Teeth without anatomic abnormalities

Exclusion Criteria:

1. Pregnant females.

2. If analgesics have been administrated during the past two weeks preoperatively.

3. Patients having bruxism or clenching.

4. Multi rooted or multi canaled teeth.

5. Patients with swelling or acute peri-apical abscess.

6. Previously endodontically treated teeth

7. periodontally affected teeth .

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• XP Endo Finisher
a flexible single use NiTi file with small diameter and no taper, changes from straight M-phase to A-phase in body temperature
• ultrasonic activated irrigation
by Satelec,Acteon, France

Locations
Country Name City State
Egypt Faculty of Oral and dental medicine, Cairo University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Alves FR, Andrade-Junior CV, Marceliano-Alves MF, Pérez AR, Rôças IN, Versiani MA, Sousa-Neto MD, Provenzano JC, Siqueira JF Jr. Adjunctive Steps for Disinfection of the Mandibular Molar Root Canal System: A Correlative Bacteriologic, Micro-Computed Tomog — View Citation

Middha M, Sangwan P, Tewari S, Duhan J. Effect of continuous ultrasonic irrigation on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Int Endod J. 2017 Jun;50(6):522-530. doi: 10.1111/iej.12666. Epub 2016 Jun 28. — View Citation

Sadaf D, Ahmad MZ. Factors associated with postoperative pain in endodontic therapy. Int J Biomed Sci. 2014 Dec;10(4):243-7. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary post-operative pain measured by NRS (Numerical rate scale) up to 1 week after the visit
Secondary Number of taken analgesic tablets counted by the patient and recorded in a given chart within a week after the visit
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Completed NCT05982392 - Effect of Preoperative Tramadol and Naproxen Sodium on Post Operative Pain Phase 2/Phase 3
Completed NCT05306470 - Ethyl Chloride Versus 5% Lidocaine for Topical Anesthesia of Oral Mucosa N/A
Completed NCT05488925 - Comparison of Preoperative Analgesics on the Efficacy of Inferior Alveolar Nerve Block. Phase 4
Completed NCT04961268 - Effect of Preoperative Oral Tramadol on Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis N/A
Completed NCT04119661 - Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles N/A
Completed NCT04202406 - Preoperative Acetaminophen- Caffeine- Codeine Combination and Anaesthetic Success in Patients With Acute Pulpitis N/A
Not yet recruiting NCT04593160 - Efficacy of Preoperative Diclofenac Potassium- Acetaminophen Combination on Anesthetic Success in Patients With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial N/A

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