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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GG test | Experimental | Patient subjected to gingivectomy and gingivoplasty interventions and anesthesia of choice is intraseptal anesthesia. |
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| GG control | Active Comparator | Patient subjected to gingivectomy and gingivoplasty interventions under the local infiltration anesthesia. |
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| PF test | Experimental | Patients undergoing periodontal flap surgery under the intraseptal anesthesia. |
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| PF control | Active Comparator | Patients undergoing periodontal flap surgery under the local infiltration anesthesia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| periodontal flap surgery | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The anesthetic efficacy | The absence of pain for two pinprick tests in a row. | 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 | 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. | 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. | 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. | 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. | one day follow-up |
| The duration | The duration of intervention, measured in minutes. | form start to finish od intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade | Belgrade | 11000 | Serbia |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D005891 | Gingivitis |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
| D005882 | Gingival Diseases |
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| ID | Term |
|---|---|
| D005890 | Gingivectomy |
| D005893 | Gingivoplasty |
| ID | Term |
|---|---|
| D019647 | Oral Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003813 | Dentistry |
| D010517 | Periodontics |
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2 parallel groups, each with the experimental and the control group
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Periodontist do not know the type of anesthesia given by the investigator
| gingivectomy and gingivoplasty | Procedure | surgical methods for the excision of hyperplastically enlarged gingiva. |
|