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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
surgical methods for the excision of hyperplastically enlarged gingiva.
Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade
Belgrade, Serbia
The anesthetic efficacy
The absence of pain for two pinprick tests in a row.
Time frame: 5 min after injection
The width of the anesthetic field on the buccal side
maximal distance between the two painless needle's pricks on the buccal aspect of attached gingiva
Time frame: 5 min after injection
The width of the anesthetic field on oral side
The maximal distance between the two painless needle's pricks on the oral aspect of the attached gingiva.
Time frame: 5 min after injection
VASa
The intensity of pain measured on 100mm Visual Analogue Scale, where 0 represented no pain and 100 the worst pain imaginable.
Time frame: immediately after anesthetic administration
VASi
The intensity of pain measured on 100mm Visual Analogue Scale, where 0 represented no pain and 100 the worst pain imaginable.
Time frame: at the end of the treatment
VASp
The intensity of pain measured on 100mm Visual Analogue Scale, where 0 represented no pain and 100 the worst pain imaginable.
Time frame: one day follow-up
The duration
The duration of intervention, measured in minutes.
Time frame: form start to finish od intervention
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