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Injectable anesthesics previous to subgingival scaling and root planing (SRP) presents some disadvantages like fear of the needle insertion, long-lasting effect and prolonged dampening of adjacent tissues. This study will compare the intrapocket anesthetic effectiveness of a skin topical anesthesic EMLA with intrapocket 2% benzocaine, intrapocket placebo and injectable anaesthesia for SRP in a Split-mouth, double-blind, clinical trial study.
Objective: The aim of this study was to compare the effect of a eutectic mixture containing 25 mg/g of lidocaine and 25 mg/g of prilocaine (EMLA®) with injectable 2% lidocaine, topical benzocaine, and 2% placebo for reducing pain during subgingival scaling and root planing (SRP) procedures.
Methods: Thirty-two patients were enrolled in this split-mouth, double-blind randomized clinical trial. Patients were randomized to a sequence of four anesthetics: 25 mg/g lidocaine and 25 mg/g of 5% prilocaine (EMLA®), injectable 2% lidocaine, topical 2% benzocaine, or placebo. Pain and discomfort were measured using a Visual Analogue Scale (VAS) and Verbal Scale (VS). Patient satisfaction with anesthesia was also determined at the end of each treatment session.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sextant 1 | Experimental | Treatment with subgingival scaling and root planing was done in 6 weekly sessions, being the sextant 1 in the randomization for experimental procedures (EMLA) |
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| sextant 2 | Active Comparator | Treatment with subgingival scaling and root planing was done in 6 weekly sessions, being the sextant 1 in the randomization for experimental procedures (Injectable anesthesia) |
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| sextant 3 | Active Comparator | Treatment with subgingival scaling and root planing was done in 6 weekly sessions, being the sextant 1 in the randomization for experimental procedures (2% Benzocaine) |
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| sextant 4 | Placebo Comparator | Treatment with subgingival scaling and root planing was done in 6 weekly sessions, being the sextant 1 in the randomization for experimental procedures (Placebo) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMLA | Drug | % eutectic mixture of 25mg/g lidocaine and 25 mg/g of prilocaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain and discomfort | For each experimental tooth, the patient was asked to indicate the intensity of pain and discomfort experienced intraoperatively using the VAS (VAStrans) (5 minutes after the start of the instrumentation in each tooth) and postoperatively (VASpost) immediately after the end of instrumentation of the respective tooth. At the end of the procedure, the patient was asked to also describe the pain sensation of the tooth using VS as: no pain (0), mild pain (1), moderate pain (2), severe pain (3), or extremely severe pain (4). | For each tooth was evaluated intraoperative pain using the Visual Analog Scale (5 minutes after the start of the instrumentation) and postoperative immediately after instrumentation. At the end of the procedure, was asked Verbal Scale, for 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with anesthesia | Patient satisfaction with anesthesia was determined at the end of all treatment sessions using the following four categories: very satisfactory, satisfied, not satisfied, and completely unsatisfactory. | Determined at the end of all treatment sessions, for 4 weeks. |
| Injectable anesthetic requirement |
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Inclusion Criteria:
Exclusion criteria:
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077442 | Lidocaine, Prilocaine Drug Combination |
| D001566 | Benzocaine |
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 |
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| Injectable anesthesia | Drug | Injectable anesthesia 2% lidocaine with epinephrine 1:100.000 |
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| 2% Benzocaine | Drug | Topical anesthetic - 200mg/g of 2% benzocaine |
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| Placebo | Drug | Manipulated with the same appearance and viscosity of topical anesthetics mentioned above |
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Percentage of subjects injectable anesthesia requirements in different anesthetic groups. In case of occurrence of pain during the subgingival SRP, an additional dose of the same anesthesic was repeated. If pain persisted after this second application, then an anesthesia infiltration/block was performed. |
| If pain persisted after this second application, then an anesthesia infiltration/block was performed, for 4 weeks. |
| Adverse Events | When each patient returned for the next treatment session, they were asked about the occurrence of pain, discomfort, localized ulceration, edema, or desquamation of the oral mucosa. | Determined when each patient returned for the next treatment session, for 4 weeks. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Organic Chemicals |
| D011318 | Prilocaine |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |