Skip to content

Comparison between the use of hand and mechanized files in the treatment of primary molar canal

Comparative analysis between hand files and rotary file in the endodontic treatment of primary molars - clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3t597f
Enrollment
Unknown
Registered
2018-05-09
Start date
2018-04-12
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Dental caries, not otherwise specified

Interventions

Control group - 44 children with need for endodontic treatment receive the treatment that includes the chemical-mechanical preparation of the root canals with manual files k -file according to the tec
Procedure/surgery
E06.397.778

Sponsors

Universidade Federal de Santa Catarina - UFSC
Lead Sponsor
Universidade Federal de Santa Catarina - UFSC
Collaborator

Eligibility

Age
4 Years to 10 Years

Inclusion criteria

Inclusion criteria: Literate caregivers; children aged 4 to 10 years; Free and Informed Consent Form signed; Term of Assent signed; children without systemic involvement in the general health; continuous use of medicines; have not taken analgesics in the last 12 hours; mandibular and maxillary primary molars; pulp necrosis; irreversible pulpitis; inter root pathological lesion; radiolucent periapical lesion not involving the germ of the permanent tooth or more than half the length of the roots; up to 2/3 of the radicular root length

Exclusion criteria

Exclusion criteria: Teeth that can not be filled; teeth that can not receive absolute isolation; external pathological reabsorption; calcifications; teeth submitted to previous endodontic treatment

Design outcomes

Primary

MeasureTime frame
Longitudinal evaluation of the success of procedures This assessment will consist of oral clinical examination, followed by instructions for oral hygiene, prophylaxis and periapical radiography of the treated tooth using the Rinn positioner. The follow-up time will be 3, 6, 12 and 24 months. Clinical success will be considered when restoration is adequate, absence of fistula and dental pain. The radiographic success will be when there is absence, paralysis or regression of radiolucent lesion

Secondary

MeasureTime frame
Evaluation of the quality of the obturation The operator calibrated and blinded to the technique of instrumentation, will evaluate the quality of the obturation. The evaluation will consist of determining if the root canal is adequately or inadequately filled (presence of voids inside the root canal), and also verify the apical limit of the obturation, which will be classified as: below the working length (more than 2mm), (0 - 2 mm from the TC) or beyond, when exceeding the working length ;Evaluation of postoperative pain The Revised Faces Pain Scale (FPS-R) will be used by caregivers to help children identify postoperative pain at 6, 12, 24, 48 and 72 hours after the procedure and will also check the use of analgesics ;Behavioral assessment The calibrated assistant will use the Frankl scale in three moments of the procedure: 1st - beginning the patient consultation in the dental chair and before starting the procedure; 2nd - in local anesthesia; 3º - in the technique of chemical-mechanical preparation of root canals ;Instrumentation time evaluation The time will be counted by the assistant during the chemical-mechanical preparation of the root canals. The time marking will begin with the first irrigation of the root canals with 2.5% Sodium Hypochlorite and will end with the instrumentation of the last hand or rotary file, irrigation with 17% EDTA and final irrigation with 2.5% Sodium Hypochlorite

Countries

Brazil

Contacts

Public ContactJéssica Barasuol

Universidade Federal de Santa Catarina - UFSC

jessica.barasuol@hotmail.com+55-047-99946 1664

Outcome results

None listed

Source: REBEC (via WHO ICTRP)