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Evaluation of Postoperative Pain and Bacterial Load Reduction With ProTaper Ultimate Versus ProTaper Gold Rotary Systems

Primary Purpose

Post Operative Pain

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Instrument Design

About this trial

This is an interventional treatment trial for Post Operative Pain

Eligibility Criteria

22 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patient's age ranges between 22 to 45 years with no sex predilection.
Medically free patients.
Maxillary permanent premolar teeth:
- Diagnosed clinically with pulp necrosis.
- Absence of pain.
- Radiographic evidence of two roots or single root with double canals.
- Slight widening in the periodontal membrane space or with peri-apical radiolucency
- No response to cold pulp tester and ethyl chloride spray.
Patients who can understand Modified Visual Analogue Scale (VAS).
Patients' acceptance to participate in the trial.

Exclusion Criteria:

Medically compromised patients.
Pregnant women.
If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
Patients reporting bruxism or clenching.
Teeth with:
i. Vital teeth. ii. Single canal maxillary premolar teeth iii. Association with swelling or fistulous tract. iv. Acute peri-apical abscess and swelling. v. Mobility Grade II or III. vi. Pocket depth more than 5mm. vii. Previous root canal therapy. viii. Non-restorable teeth: Hopeless tooth
Immature teeth.
Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification, root caries.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Protaper Ultimate

Protaper Gold

Arm Description

Outcomes

Primary Outcome Measures

Post Operative Pain

Intensity of pain felt after endodontic treatment recorded by the patient using modified Visual Analogue Scale where 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain

Secondary Outcome Measures

Number of needed analgesic tablets in case of intolerable pain

The patient will record the number of analgesic tablets taken in case of intolerable pain

Antibacterial Effectiveness

Bacterial counting using agar Culture technique

Full Information

NCT ID

NCT05305742

First Posted

December 24, 2021

Last Updated

March 30, 2022

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05305742

Brief Title

Evaluation of Postoperative Pain and Bacterial Load Reduction With ProTaper Ultimate Versus ProTaper Gold Rotary Systems

Official Title

Evaluation of Postoperative Pain and Bacterial Load Reduction After Canal Preparation With ProTaper Ultimate Versus ProTaper Gold Rotary Systems in Patients With Necrotic Maxillary Premolars (Randomized Clinical Trial)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 1, 2022 (Anticipated)

Primary Completion Date

January 31, 2023 (Anticipated)

Study Completion Date

February 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study aims to research the effect of different instrument designs by comparing protaper ultimate versus protaper gold systems on root canal preparation by evaluating bacterial count reduction and post-operative pain following single visit treatment in patients with necrotic pulp in maxillary premolar teeth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Operative Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Protaper Ultimate

Arm Type

Experimental

Arm Title

Protaper Gold

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Instrument Design

Intervention Description

Research the effect of different instrument designs on root canal preparation by evaluating bacterial count reduction and post-operative pain

Primary Outcome Measure Information:

Title

Post Operative Pain

Description

Intensity of pain felt after endodontic treatment recorded by the patient using modified Visual Analogue Scale where 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain

Time Frame

Postoperative pain will be measured by modified Visual Analogue Scale immediately after the end of treatment, and at 6, 12, 24 and 48 hours.

Secondary Outcome Measure Information:

Title

Number of needed analgesic tablets in case of intolerable pain

Description

The patient will record the number of analgesic tablets taken in case of intolerable pain

Time Frame

Patient will be contacted after 48 hours after endodontic treatment to know the number of analgesic tablets taken

Title

Antibacterial Effectiveness

Description

Bacterial counting using agar Culture technique

Time Frame

First as a Baseline (T0): After the access cavity Sample 1 will be taken, after 15 minutes (T1) mechanical instrumentation will be done and Sample 2 will be taken, after 5 minutes from T1 (T2) final irrigation will be done and Sample 3 will be taken.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient's age ranges between 22 to 45 years with no sex predilection. Medically free patients. Maxillary permanent premolar teeth: Diagnosed clinically with pulp necrosis. Absence of pain. Radiographic evidence of two roots or single root with double canals. Slight widening in the periodontal membrane space or with peri-apical radiolucency No response to cold pulp tester and ethyl chloride spray. Patients who can understand Modified Visual Analogue Scale (VAS). Patients' acceptance to participate in the trial. Exclusion Criteria: Medically compromised patients. Pregnant women. If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively. Patients reporting bruxism or clenching. Teeth with: i. Vital teeth. ii. Single canal maxillary premolar teeth iii. Association with swelling or fistulous tract. iv. Acute peri-apical abscess and swelling. v. Mobility Grade II or III. vi. Pocket depth more than 5mm. vii. Previous root canal therapy. viii. Non-restorable teeth: Hopeless tooth Immature teeth. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification, root caries.

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Postoperative Pain and Bacterial Load Reduction With ProTaper Ultimate Versus ProTaper Gold Rotary Systems

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