Assessment of Postoperative Pain and Bacterial Load Reduction After Using TruNatomy and ProTaper Next Rotary Systems in Patients With Necrotic Mandibular Molars: A Randomized Clinical Trial

NCT04862702 | Unknown DMC

• 1 other identifier: ENDO:3-3-5
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to assess the effect of rotary instrumentation using ProTaper Next rotary system versus TruNatomy rotary system on postoperative pain and the bacterial load reduction following single visit root canal treatment in necrotic mandibular molars.

Conditions

Endodontic Treatment

Outcome Measures

Primary Outcomes (1)

• Intensity of postoperative pain

  Postoperative pain will be measured by modified VAS at 6, 12, 24 and 48 hours post-obturation. The modified VAS consists of from 0-10 point scale anchored by two extremes "No pain" and "pain as bad as could be". The patients will be asked to choose the mark on an appendix that represents their level of pain. Pain level will be assigned to one of four categorical scores: 1. None (0) 2. Mild (1-3) 3. Moderate (4-6) 4. Severe (7-10) numerical rating scale (NRS) at 6, 12, 24 and 48 hours post-obturation and at 6, 12, 24 and 48 hours post-obturation.

  48 hours

Secondary Outcomes (1)

• Bacterial load reduction

  24 hours

Study Arms (2)

ProTaper Next rotary file system (Dentsply Sirona)

ACTIVE COMPARATOR

Device: mechanical instrumentation using rotary file system

TruNatomy rotary system (Dentsply Sirona)

EXPERIMENTAL

Device: mechanical instrumentation using rotary file system

Interventions

mechanical instrumentation using rotary file system DEVICE

the mechanical preparation will be performed using rotary file system

ProTaper Next rotary file system (Dentsply Sirona); TruNatomy rotary system (Dentsply Sirona)

Eligibility Criteria

• Age: 22 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Medically free patients.
• Mandibular permanent molar teeth:
• Diagnosed clinically with pulp necrosis.
• Absence of spontaneous pain.
• Slight widening in the periodontal membrane space or with periapical radiolucency
• Patient's age ranges between 22 to 45 years with no sex predilection.
• Patients who can understand Modified Visual Analogue Scale (VAS).
• Patients' acceptance to participate in the trial.
• Patients able to sign 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 show 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.
• Vital teeth.
• Immature teeth.
• Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

yasmin Hamdy Hussein AbdAlmoniem, masters

CONTACT

01273398477; Yasmin.Hamdy@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The assistant supervisor is the one who will generate the random sequence, assign the participants to the intervention or control groups and the only one who knows whether A or B represents the intervention or the control. The operators will enroll the participants after they find the eligible ones and confirm with the assistant supervisor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant lecturer

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: April 28, 2021
• Study Start: September 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 28, 2021

Record last verified: 2021-04