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Clinical study for the evaluation of different local anesthetic dental techniques

Comparison of pain perception using conventional and computerized anesthetic techniques: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-89rd4p
Enrollment
Unknown
Registered
2018-12-11
Start date
2018-08-06
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

Periodontitis

Interventions

This is a split-mouth self-controlled, randomized, double-blind, transverse study. Drugs and materials used in the research: 2% Lidocaine anesthetic solution with epinephrine 1: 100,000
topical anesthetic based on benzocaine 20%
27-gauge mucogingival needles (short or long according to the technique employed)
self aspirating carpule syringe
computerized anesthetic injector with controlled speed Morpheus
opaque lens glasses to blind the patient
McCall and Gracey manual curettes specific to the sites to be instrumented. The amount of anesthetic injected will vary according to the technique and region to be anesthetized, always following the a
Drug
Procedure/surgery
Behavioural
E03.155.086.231
E02.950

Sponsors

Universidade Estadual de Ponta Grossa
Lead Sponsor
Universidade Estadual de Ponta Grossa
Collaborator

Eligibility

Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Patients should be at least 18 years of age with chronic periodontal disease, presenting at least one vital tooth with a clinical depth of probing greater than or equal to 4 mm in at least one of the probed sites in three different hemiarcates.

Exclusion criteria

Exclusion criteria: Patients in periodontal maintenance; sensitivity or any form of allergic reaction to amide-based anesthetics; have used analgesic or anesthetic medication for at least 12 hours prior to the periodontal instrumentation procedure; patients with previous history of alcoholism; pregnant or lactating women; patients with severe uncontrolled systemic disease such as heart, neurological, renal, hepatic or blood problems; psychiatric problems that could interfere with the scaling and smoothing or administration of topical anesthetics and injectables. Local pathological changes such as presence of ulcerative lesions, abscesses, acute infections; need for exodontia in the study quadrant; dentin hypersensitivity; absence of vitality or other pulp pathologies that could interfere in the measurement of the data in the teeth involved in the research.

Design outcomes

Primary

MeasureTime frame
The expected primary outcome is a smaller pain scale for anesthesia with Morpheus equipment compared with conventional and rapid anesthesia. The method used to verify the expected outcome is the NRS 11-point scale (Numerical Rating Scale) for pain intensity. The parameter used is scores (from 0 to 10).

Secondary

MeasureTime frame
The secondary endpoint A, B and C are the physiological parameters for anxiety, ie, heart rate, B blood pressure, C oxygen saturation. All three parameters will be measured with the Inmax instrument. The heart rate will be measured in beats per minute. Blood pressure will be measured in millimeters of mercury. The oxygen saturation will be measured as a percentage of oxygen in the blood. Outcome D comprises the number of anesthetic completions required during the non-surgical periodontal procedure, reported by the dentist or graduate who is performing the procedure. Outcome E comprises the efficacy of anesthesia, measured by a 5-point Likert scale, that is, from 1 to 5, where the patient will answer the question whether the anesthesia he received was effective, with options 1 totally disagree, 2 I disagree, 3 indifferent, 4 agree, 5 agree totally.

Countries

Brazil

Contacts

Public ContactAna Dalmolin

Universidade Estadual de Ponta Grossa

anaclaudiadalmolin@gmail.com+55-42-32203740

Outcome results

None listed

Source: REBEC (via WHO ICTRP)