Comparison of Postoperative Effects of Articaine and Lidocaine in Mucogingival Surgery

Pamukkale University43 enrolled

Overview

The aim of this study is to compare and evaluate the effects of using lidocaine 2% (with adrenaline) and articaine 4% (with adrenaline) in free gingival graft (FGG) surgery on postoperative wound healing, changes in blood flow in the surgical area during the healing process, patients' postoperative pain levels, and anxiety levels before and after surgery.

In a prospective randomised controlled trial conducted to investigate the effect of lidocaine and articaine on postoperative free gingival graft healing, wound healing was assessed using EHS, anxiety was assessed using VAS, STAI, and MDAS questionnaires, and ultrasonographic evaluations and PI measurements were used to determine whether there was a difference in wound healing between the two anaesthetics.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Local Analgesia Via Infiltration Wound Heal Pain, Postoperative Hemorrhage

Interventions

Lidocaine hydrochloride 2% with epinephrine 1:100 000DRUG

Patient were received infiltrative anesthesia with Lidocaine (Jetokain, Adeka Ilaç, Samsun, Türkiye): Active ingredient: Each 1 ml contains 20 mg lidocaine hydrochloride (HCL) and 0.012 mg epinephrine base. Excipients: Sodium metabisulfite, sodium chloride, water for injection.

Articaine 4% with epinephrine 1:100,000DRUG

Patients were received Infiltrative anesthesia with Articaine (Ultracain DS Forte, Sanofi Aventis İlaçları, Istanbul, Türkiye): Active ingredient: 40 mg articaine HCL and 0.012 mg epinephrine per 1 ml. Excipients: Sodium chloride, sodium metabisulfite, hydrochloric acid, water for injection

Free gingival graft (FGG)PROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients\> 18 years requiring FGG surgery with ≤ 1 mm width of attached gingiva * No systemic diseases or pregnancy. * Smoking ≤10 cigarettes/day * Full-mouth plaque score and full-mouth bleeding score ≤10% (four sites per tooth). * Need for FGG due to insufficient attached gingiva * No history of mucogingival or periodontal surgery at experimental sites Exclusion Criteria: * Use of oral contraceptives, psychotropic drugs, sedatives, or NSAIDs * Allergy or hypersensitivity to local anesthetics, * Orofacial neurological symptoms, * Active infection in the surgical area, * Pathological mental conditions such as dementia or psychosis, or lack of cooperation,

Locations (1)

Pamukkale University Faculty of Dentistry

Denizli, Turkey (Türkiye)

Outcomes

Primary Outcomes

early wound healing score (EHS)

The healing of the recipient site was evaluated using the EHS index during clinical exams on postoperative days 3, 7, and 14. The EHS index includes parameters of hemostasis (CSH), inflammation (CSI), and re-epithelialization (CSR). The total score ranges from 0 (worst healing) to 10 (best healing)

Time frame: 3rd day, 7th day, 14th day

Secondary Outcomes

Ultrasonographic Evaluations

All patients were evaluated using an ultrasonography (USG) device (MyLab™ Seven, Esaote, Genoa, Italy) in the Department of Oral and Maxillofacial Radiology. USG examinations were performed by an oral and maxillofacial radiologist with at least eight years of experience before graft harvesting and on the 3rd, 7th, and 14th days after FGG operations in both recipient and donor sites.

Time frame: 3rd, 7th, and 14th days

Modified Dental Anxiety Scale (MDAS)

The MDAS includes five scores that progressively increase from "not anxious" to "extremely anxious" for each question. Therefore, the highest score for each question is 5, and the total score for the scale ranges from 5 to 25, with 25 being the maximum

Time frame: baseline and 14 days after the procedure,

State-Trait Anxiety Inventory (STAI-S and STAI-T)

The trait anxiety section (STAI-T) helps measure how the individual has felt over the past weeks, while the state anxiety section (STAI-S) is designed to assess how the individual feels at that moment. Participants are asked to select the statement that best describes their feelings from the options provided: "definitely not," "sometimes," "often," or "almost always." Positive scores were assigned to the statements in items 3, 4, 6, 7, 9, 12, 13, 14, 17, and 18, while negative scores were assigned to the statements in items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. A score of 80 was considered the highest, while 20 was the lowest

Time frame: baseline and 14 days after the procedure,

Data from ClinicalTrials.gov

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