Comparison of Postoperative Effects of Articaine and Lidocaine in Mucogingival Surgery

Not Applicable

Completed

• Conditions: Local Analgesia Via Infiltration; Wound Heal; Pain, Postoperative; Hemorrhage
• Interventions: Procedure: Free gingival graft (FGG)

• Registration Number: NCT07145879
• Lead Sponsor: Pamukkale University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2025-01-01
• Primary Completion: 2025-07-30
• Study Completion: 2025-07-30
• Status Verified: 2025-08
• Study First Submitted: 2025-08-14
• Study First Submitted QC: 2025-08-27
• Last Update Submitted: 2025-08-27
• Study First Posted: 2025-08-28
• Last Update Posted: 2025-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
lidocaine HCL	Free gingival graft (FGG)	Participants will receive lidocaine HCL 2% with adrenaline for local anesthesia before free gingival surgery once only
articaine HCL	Free gingival graft (FGG)	Participants will receive articaine HCL 4% with adrenaline for local anestesia before free gingival surgery once only

Primary Outcome Measures

Name	Time	Method
early wound healing score (EHS)	3rd day, 7th day, 14th day	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)

Secondary Outcome Measures

Name	Time	Method
Ultrasonographic Evaluations	3rd, 7th, and 14th days	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.
Modified Dental Anxiety Scale (MDAS)	baseline and 14 days after the procedure,	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
State-Trait Anxiety Inventory (STAI-S and STAI-T)	baseline and 14 days after the procedure,	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

Trial Locations

Locations (1)

Pamukkale University Faculty of Dentistry; Denizli, Turkey (Türkiye)