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Clinical evaluation of pain during gum treatment using anesthetic gels with no needles.

Clinical evaluation of pain perception during scaling and root planning, using non-invasive lidocaine/prilocaine thermosetting liposomal anesthesia gel.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-934sys
Enrollment
Unknown
Registered
2017-03-23
Start date
2012-09-01
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

Gingival Diseases

Interventions

We will include 40 patients who need treatment in the gingiva. Each volunteer will be submitted to gingival treatment with different local anesthetics on the different sides of the mouth, being: 1. PL
2. LI lidocaine and prilocaine liposomal gel
3. OR lidocaine and prilocaine commercial anesthetic gel (Oraqix). For the application of local anesthetics, the side of the mouth will be kept dry with cotton rollers and they will be applied to the
Drug
Procedure/surgery
C07.465.714.258
E03.155.086.231

Sponsors

Universidade Estadual de Ponta Grossa
Lead Sponsor
Curso de Odontologia - Universidade Estadual de Ponta Grossa
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers, any gender, older than 18 years, at least three sextants who require periodontal treatment, at least one tooth with clinical depth of probing >= 4mm.

Exclusion criteria

Exclusion criteria: Volunteers under periodontal maintenance, sensitivity or allergy to amide-based anesthetics, use of analgesic or anesthetic medication at least 12 hours prior to the procedure, previous history of alcoholism, pregnant or lactating women, uncontrolled severe systemic disease, acute local pathological alterations, dental extraction needs, dentin hypersensitivity and endodontic treatment.

Design outcomes

Primary

MeasureTime frame
During and after treatment of the gingiva, the pain intensity will be analyzed in relation to the periodontal procedure. Pain intensity during the gingival treatment through pain frequency, in which the volunteer will use a digital counter to record any painful sensation. At the end of the treatment, two scales will be applied for pain assessment (4-points verbal rate scale and 101-points numerical rate scale). Thus, we expected to verify if local anesthesia with no needles can contribute to the gingival treatment mainly of individuals who do not tolerate injecting dental anesthesia well.;The results showed that the pain intensity during periodontal instrumentation is low, with no differences between experimental groups with placebo in all parameters evaluated

Secondary

MeasureTime frame
Secondary outcomes were: arterial pressure, heart rate, oxygen saturation, volume of anesthetic gel applied, number of applications performed, need for injectable anesthesia, operative difficulties and postoperative discomfort.;For secondary variables such as arterial pressure and heart rate we expected an increase of these parameters in placebo group. Considering, oxygen saturation low levels will be expected for placebo group. The volume of anesthetic gel applied, number of applications performed and need for injectable anesthesia we expected higher numbers in placebo group. After statistical analysis, we did not find significant differences between groups. Only the placebo group presented greater operative difficulties than the other experimental groups (p <0.05).

Countries

Brazil

Contacts

Public ContactFábio dos Santos

Universidade Estadual de Ponta Grossa

fasantos11@gmail.com+55 (42) 32203104

Outcome results

None listed

Source: REBEC (via WHO ICTRP)