The Effect of Using Reciprocal Files Alone and With Different Files on Postoperative Pain

NCT06833515 | Completed

• 1 other identifier: HRÜ-DHF-END-NC-02
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effects of using the Wave One Gold file alone and in combination with different files on postoperative pain in patients with asymptomatic apical periodontitis. The results of the study may provide important insights into the impact of these file systems on postoperative pain. . The main questions it aims to answer are: It will also reveal whether reciprocating files can be used alone or not. Participants will: Go under treatment with different shaping protocols The researchers will shape using only the Wave One gold file in the first group. In the second group, they will first perform coronal shaping with the One Flare file and then complete the final shaping with the Wave One Gold file In the third group, coronal shaping will first be performed with the One Flare, followed by working length shaping with the Wave One Gold glider file, and the final shaping will again be completed with the Wave One file. For sham group Using a #10K-type stainless-steel file, the operator will establish the working length 0.5 mm short of the apex indicated by the apex locator and will confirm it on periapical radiograph. The operator will prepare the glide path using a #15K-type stainless-steel hand file with push-pull motion.On sensing resistance, the file will withdraw. recapitulation was performed with a #10K-type operator then will irrigate the root canals with 2 mL of 5%NaOCl . Then, they will be shaped using WaveOne Gold Glider and WaveOne in reciprocal mode. After the treatment, the patient's pain score will be recorded. They will Visit the clinic three days later Keep avisual analogue scala of their symptoms and than compare different shaping protocols

Conditions

Post Operative Pain; Chronic Apical Periodontitis of Pulpal Origin

Keywords

rotary; reciproc; mode; pain; periodontitis

Outcome Measures

Primary Outcomes (1)

• visual analoge scala

  it contains 5 different images correlated with severity of pain with 10 numeric levels of pain. Minimum value of pain is 1 while the highest value is 10. 10 is a worse value of pain than 1.

  24-48-72 hours

Study Arms (4)

one flare+wave one gold glider+wave one gold

ACTIVE COMPARATOR

Using a #10K-type stainless-steel file, the operator will establish the working length 0.5 mm short of the apex indicated by the Root ZX Mini apex locator and will confirm it on periapical radiograph. The operator then will irrigate the root canals with 2 mL of 5%NaOCl . Teeth in this group will first be shaped in rotational mode using One Flare. Then, they will be shaped using WaveOne Gold Glider and WaveOne in reciprocal mode. After the treatment, the patient's pain score will be recorded.

Other: one flare+wave one gold glider+wave one gold

waveone gold glider+waveone gold

ACTIVE COMPARATOR

Using a #10K-type stainless-steel file, the operator will establish the working length 0.5 mm short of the apex indicated by the Root ZX Mini apex locator and will confirm it on periapical radiograph. The operator then will irrigate the root canals with 2 mL of 5%NaOCl. this group teeth will be operated using reciprocal motion with waveone gold glider and waveone gold. After the treatment, the patient's pain score will be recorded.

Other: wave one gold glider+wave one gold

waveone gold

ACTIVE COMPARATOR

Using a #10K-type stainless-steel file, the operator will establish the working length 0.5 mm short of the apex indicated by the Root ZX Mini apex locator and will confirm it on periapical radiograph. The operator then will irrigate the root canals with 2 mL of 5%NaOCl. this group teeth will be operated using reciprocal motion with wave one gold. After the treatment, the patient's pain score will be recorded.

Other: wave one gold

15K-type stainless-steel hand file

PLACEBO COMPARATOR

Canal preparation was performed using stainless steel manual K-files with the step-back technique. Apical preparation was enlarged up to a #25 K-file at the working length. Subsequently, using larger files, progressive coronal enlargement was performed according to the step-back approach to achieve appropriate canal taper.

Other: 15K-type stainless-steel hand file

Interventions

one flare+wave one gold glider+wave one gold OTHER

In this clinical study, the teeth will first undergo coronal shaping with the One Flare file. Then, the glide path and final shaping will be performed in reciprocal mode with reciprocal files.

one flare+wave one gold glider+wave one gold

wave one gold glider+wave one gold OTHER

In this group, only the glide path and final shaping will be performed using reciprocal files, without coronal shaping.

waveone gold glider+waveone gold

wave one gold OTHER

In this group, shaping will be performed using only a reciprocating file, without coronal shaping and glide path preparation.

waveone gold

15K-type stainless-steel hand file OTHER

The operator prepared the glide path using a #15K-type stainless-steel hand file with push-pull motion. On sensing resistance, the file was withdrawn, recapitulation was performed with a #10K-type stainless-steel file, and debris was removed by irrigating the canals with 5% NaOCl. The operator repeated this procedure until the #15K-file reached the complete working length

15K-type stainless-steel hand file

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult, systemically healthy patients aged18-65years(category:AmericanSocietyof Anesthesiologists class 1.
• Patients diagnosed with symptomatic reversible pulpitis and having mandibular first and second premolar teeth without percussion pain.
• Teeth with prolonged response to the coldpulp test (Endo-Frost, Coltene-Whaledent, Allstetten, Switzerland) (teeth where pain persists for a long time after stimulus removal)
• Teeth with normal periapical appearance(periapical index 2), a single root canal andaroot canal inclination less than 20° on a parallel periapical radiograph
• Teeth with moderately sharp spontaneous pain (preoperative visual analog scale \[VAS\] score 4-6)
• Teeth where number 10 K files can reach and fit the working lenght
• Patients who were able to understand the informed consent form and pain recording scales used in the study were included

You may not qualify if:

• Patients who are pregnant and lactating
• Patients who received analgesics or anti inflammatory drugs in the last 12 hours and antibiotics for the last 1 month
• Patients with severe periodontal defect or deep periodontal pocket (probing depth.3 mm)and poor oral hygiene
• Teeth too broken down, difficult to isolate with rubber dam
• Teeth without occlusal contact
• Presence of multiple teeth requiring treatment, a previous treatment history and an open apex
• Teeth with calcified root canal, root resorption, crown and/or root fracture, multiple root canals, post, and sinus tract were excluded from the study -• VAS pain score of 1 and above

Sponsors & Collaborators

• Harran University: lead

Study Sites (1)

Nezif Çelik

Karaköprü, Şanlıurfa, 63300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain; Periodontitis

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• tolga han edebal, PhD

  HARRAN UNİVERSTY

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: experimental groups

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 18, 2025
• Study Start: March 15, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 10, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)