Comparison of Post-operative Pain After Using Different File Systems

NCT ID: NCT06665152

Last Updated: 2024-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-07-18

Brief Summary

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To compare the postoperative pain in patients undergoing root canal instrumentation with two different file systems, WaveOne and ProTaper systems.

Detailed Description

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Endodontic postoperative pain is experienced after the procedure of root canal. It is defined as an unpleasant sensation, of varying degree, experienced by the patients. Depending upon the individual and other variable, the range of postoperative pain lies between 3% to 58%. Endodontic postoperative pain could occur due to various factors that can be microbial, injured pulp, chemical, or mechanical. Factors that influence pain following a root canal include the presence of preoperative pain, apical debris extrusion, intracanal interappointment dressing extrusion, presence of periapical pathosis, hyper occlusion, and irrigant extrusion.

Although apically extruded debris can be reduced through various means, it cannot be completely avoided. Thus, increasing the incidence of postoperative pain in patients. The debris produced during apical extrusion contains necrotic tissue, dental chips, microbes, pulp tissue, and canal irrigants. The infected debris may disturb the balance between the microbes and the immune system, leading to acute exacerbation.

Manual steel K files tend to produce more debris, causing a high risk of postoperative discomfort. Nickel-titanium rotary instruments powered by the engine have various advantages including; time-saving, preservation of root canal anatomy, and homogeneous preparation of the shape of the root canal. The debris produced by these instruments is potentially lesser than the manual files. Mainly because they have rotary action and they excavate the debris with the help of their flutes. Repeated irrigation along with the action of an engine-driven instrument, has the potential to decrease postoperative pain. WaveOne reciprocating file instruments have potential advantages including reduced fatigue, resistance to fracture, less debris extrusion, good shaping ability, no cross-contamination (single use), and reduced cost.

Relation between debris extrusion and postoperative care has not been established in any previous study. This study is aimed at comparing the use of ProTaper Universal and WaveOne system, for preparation of permanent human teeth during root canal procedure and their effect on postoperative pain.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparison of postoperative pain in two groups of patients, who underwent root canal treatment with two different file systems. total 74 patients divided into two groups and given different interventional treatment to monitor pain after treatment.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
The patients did not know which file system was used in their treatment. The investigator was also not disclosed the intervention's name; rather, a code name was given to them.

Outcomes accessor also did not know the exact name but was provided with a code name.

Study Groups

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ProTaper Group

These patients underwent root canal treatment due to pain in their molar teeth. The file system used in this arm was ProTaper (Dentsply), a rotary file system that moves in a complete 360° rotation and prepares a root canal.

Group Type EXPERIMENTAL

ProTaper File System

Intervention Type DEVICE

A rotary file system

WaveOne Group

These patients underwent root canal treatment due to pain in their molar teeth. The file system used in this arm was WaveOne(Dentsply), a reciprocating file system that moves in 150° anticlockwise and 30° clockwise motion and prepares a root canal.

Group Type ACTIVE_COMPARATOR

WaveOne File System

Intervention Type DEVICE

A reciprocating file system

Interventions

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ProTaper File System

A rotary file system

Intervention Type DEVICE

WaveOne File System

A reciprocating file system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients with unremarkable/ noncontributory medical history
2. Healthy persons between the ages of 18 and 60 years
3. Maxillary and mandibular molar teeth diagnosed with symptomatic irreversible pulpitis.
4. Patients not having taken any medication for 6 hours before treatment
5. No allergies to the drugs or dental material being used in the treatment

Exclusion Criteria

1. Patients who had taken analgesics on anti-inflammatory drugs within the last 12 hours
2. Pregnant women and patients with immunocompromised health state
3. Patients having severe malocclusion associated with traumatic occlusion
4. Teeth with calcified canals
5. Teeth with periapical radiolucency
6. Teeth with root resorption
7. Teeth previously undergone root canal treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ahmed Abdullah

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abdullah

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nadeem A Rana, BDS, FCPS

Role: STUDY_DIRECTOR

CMH LMC IOD

Locations

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28 MDC

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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CMHLMCIOD

Identifier Type: -

Identifier Source: org_study_id

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