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How the shape of root canal instruments affects pain after treatment: findings from a clinical study

Randomized Clinical Trial on the Influence of Instrument Taper and Design on the Occurrence and Intensity of Postoperative Pain in Endodontic Treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-6d5vscv
Enrollment
Unknown
Registered
2025-12-10
Start date
2025-08-01
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Pain Measurement

Interventions

This is a two-arm, double-blind, randomized controlled clinical trial including a total of 124 participants requiring endodontic treatment in posterior teeth, randomly allocated into two groups of 62

Sponsors

Pontificia Universidade Católica de Campinas - PUC/ CAMPINAS
Lead Sponsor
Pontificia Universidade Católica de Campinas - PUC/ CAMPINAS
Collaborator

Eligibility

Age
19 Years to 92 Years

Inclusion criteria

Inclusion criteria: Posterior teeth (premolars or molars) indicated for endodontic treatment. teeth with vital pulp (living dental pulp). teeth requiring endodontic therapy for prosthetic purposes (as abutments for crowns or bridges). patients between 19 and 92 years old

Exclusion criteria

Exclusion criteria: Pulp necrosis (non-vital pulp). acute or chronic apical periodontitis. previously endodontically treated teeth. symptomatic or asymptomatic irreversible pulpitis. root resorption (internal or externalm incomplete root formation or open apical foramen. cases where apical patency cannot be established. patients with recent use of analgesics or anti-inflammatory drugs. which could interfere with pain perception

Design outcomes

Primary

MeasureTime frame
Value the intensity of postoperative pain experienced by patients after endodontic treatment, assessed using the Visual Analog Scale (VAS), in which participants rate their pain from 0 (no pain) to 10 (worst possible pain). Pain levels will be recorded at 24, 48, and 72 hours, and 7 days after the procedure. This outcome represents a quantitative, continuous, and patient-reported measure (PROM) and aims to compare pain intensity between the ProTaper® Universal and ProTaper® Ultimate rotary systems.

Secondary

MeasureTime frame
Value if the use of analgesic medication, recorded as a binary variable (yes/no) to determine differences in analgesic need between groups; the duration of pain, measured by the number of days patients report postoperative discomfort; and the association between pain intensity and demographic factors such as age, sex, and tooth type. These secondary outcomes will help identify individual and clinical variables that may influence pain perception, providing a more comprehensive understanding of patient response and postoperative comfort.

Countries

Brazil

Contacts

Public ContactLuana Davanso

Pontifícia universidade católica de Campinas

luanadavanso@outlook.com+55 (11) 944609324

Outcome results

None listed

Source: REBEC (via WHO ICTRP)