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Postoperative Pain of Rotary Versus Reciprocating Motions of Two Single Files

Postoperative Pain After Pulpectomy of Primary Molars Using With Rotary Versus Reciprocation Motions of Two Single Files: A Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05059171
Enrollment
260
Registered
2021-09-28
Start date
2020-11-16
Completion date
2021-08-31
Last updated
2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Brief summary

An equivalent parallel randomized clinical trial was approved by the local University Committee of Ethics. 260 children with necrotic primary molars were allocated into 2 equal groups (82 children per group). The participants were allocated into two groups; group 1 teeth were instrumented with OneShape rotary system (Micro Mega, Besancon, France), and group 2 teeth were instrumented with WaveOne Gold reciprocating system (Dentsply Maillefer, Ballaigues, Switzerland). Postoperative pain was assessed using a four-point pain intensity rating scale adopted from Wong-Baker FACES (WBF) pain scale . The face scale consists of four faces with a brief title describing each face representing a scale from the first face (score 1), second face (score 2), third face (score 3), and forth face (score 4) 3. Postoperative pain was assessed at 6 six time intervals (at 6, 12, 24, 48, 72 hours and one-week).

Interventions

DEVICEOneSahpe single file

The rotary motion of OneShape single file

DEVICEWaveOne Gold single file

reciprocation motions of WaveOne Gold single file

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes

Inclusion criteria

1. Children ages from 4 to 8 years classified as class I or II according to the American Society of Anesthesiologists (ASA). 2. No previous dental experience. 3. Non-vital primary molar (necrotic or with chronic apical periodontitis) which confirmed radiographicly with the presence or absence of periapical radiolucency. 4. Severe tooth mobility.

Exclusion criteria

1. Severe behaviour or emotional disabilities. 2. Analgesic intake in the preceding 12 hours. 3. Non-restorable crowns of primary molars. 4. Radiographic presence of internal root resorption or massive bone destruction. 5. Root resorption exceeded one-third of the root length. \-

Design outcomes

Primary

MeasureTime frameDescription
Postoperative painOne weekPostoperative pain was assessed using a four-point pain intensity rating scale adopted from Wong-Baker FACES (WBF) pain scale . The face scale consists of four faces with a brief title describing each face representing a scale from the first face (score 1), second face (score 2), third face (score 3), and fourth face (score 4) 17. Postoperative pain was assessed at 6 six time intervals

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026