Gingivitis and Periodontal Diseases, Periodontitis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREperiodontal 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.
PROCEDUREgingivectomy and gingivoplasty
surgical methods for the excision of hyperplastically enlarged gingiva.
Sponsors
University of Belgrade
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
Periodontist do not know the type of anesthesia given by the investigator
Intervention model description
2 parallel groups, each with the experimental and the control group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The anesthetic efficacy | 5 min after injection | The absence of pain for two pinprick tests in a row. |
| The width of the anesthetic field on the buccal side | 5 min after injection | maximal distance between the two painless needle's pricks on the buccal aspect of attached gingiva |
| The width of the anesthetic field on oral side | 5 min after injection | The maximal distance between the two painless needle's pricks on the oral aspect of the attached gingiva. |
| VASa | immediately after anesthetic administration | The intensity of pain measured on 100mm Visual Analogue Scale, where 0 represented no pain and 100 the worst pain imaginable. |
| VASi | at the end of the treatment | The intensity of pain measured on 100mm Visual Analogue Scale, where 0 represented no pain and 100 the worst pain imaginable. |
| VASp | one day follow-up | The intensity of pain measured on 100mm Visual Analogue Scale, where 0 represented no pain and 100 the worst pain imaginable. |
| The duration | form start to finish od intervention | The duration of intervention, measured in minutes. |
Countries
Serbia
Outcome results
None listed