Effectiveness of Intraseptal Anesthesia for Periodontal Surgical Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-22

Study Completion Date

2026-04-30

Brief Summary

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The primary aim of this study is to evaluate the efficacy of intraseptal anesthesia using 0.3 mL of 4% articaine with 1:100,000 epinephrine (4% Ar+Ep) for periodontal flap surgery in patients with periodontitis and for gingivectomy/ gingivoplasty for the excision of hyperplastic gingival enlargements. The secondary aim is to compare clinical anesthetic parameters between the ISA and conventional anesthesia techniques.

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Detailed Description

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In the test groups every patient is going to receive injections of 0.3 mL of 4% articaine with 1: 100,000 epinephrine (ORABLOC ® , 40 mg/ml Articaine + 0.01 mg/ml Epinephrine, PIERREL S.P.A, Capua, Italy), with a computer controlled anesthesia delivery system (Anaeject®, Septodont, Sallanches, France). In the control groups all surgical procedures is going to be performed under infiltration anesthesia, as commonly used in periodontal surgery. The success rate and the anesthetic field widths is going to be recorded by pinprick testing. The pain levels will be recorded using the Visual Analogue Scale (VAS) for the administration of anesthesia, during the surgical procedure and after the intervention.

Conditions

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Periodontitis Gingivitis and Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 parallel groups, each with the experimental and the control group

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Periodontist do not know the type of anesthesia given by the investigator

Study Groups

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GG test

Patient subjected to gingivectomy and gingivoplasty interventions and anesthesia of choice is intraseptal anesthesia.

Group Type EXPERIMENTAL

gingivectomy and gingivoplasty

Intervention Type PROCEDURE

surgical methods for the excision of hyperplastically enlarged gingiva.

GG control

Patient subjected to gingivectomy and gingivoplasty interventions under the local infiltration anesthesia.

Group Type ACTIVE_COMPARATOR

gingivectomy and gingivoplasty

Intervention Type PROCEDURE

surgical methods for the excision of hyperplastically enlarged gingiva.

PF test

Patients undergoing periodontal flap surgery under the intraseptal anesthesia.

Group Type EXPERIMENTAL

periodontal flap surgery

Intervention Type PROCEDURE

Open flap debridement with intra-sulcular incisions or flaps with para-marginal incisions were performed by lifting the mucoperiosteal flap and debriding the periodontal defect under visual control.

PF control

Patients undergoing periodontal flap surgery under the local infiltration anesthesia.

Group Type ACTIVE_COMPARATOR

periodontal flap surgery

Intervention Type PROCEDURE

Open flap debridement with intra-sulcular incisions or flaps with para-marginal incisions were performed by lifting the mucoperiosteal flap and debriding the periodontal defect under visual control.

Interventions

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periodontal flap surgery

Open flap debridement with intra-sulcular incisions or flaps with para-marginal incisions were performed by lifting the mucoperiosteal flap and debriding the periodontal defect under visual control.

Intervention Type PROCEDURE

gingivectomy and gingivoplasty

surgical methods for the excision of hyperplastically enlarged gingiva.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age ≥18 years good systemic health
* gingivitis or periodontitis stage II and III
* at least 20 teeth present.

Exclusion Criteria

* allergy to 4%Ar+Ep
* pregnant or lactating females
* medication uptake and diseases affecting the periodontal tissues
* acute pain, swelling, and presence of gingival lesions.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No