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Comparison of Postoperative Effects of Articaine and Lidocaine in Mucogingival Surgery

Differences in Soft Tissue Healing and Vascularization Between Articaine and Lidocaine: A Randomized Clinical and Ultrasonographic Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07145879
Enrollment
43
Registered
2025-08-28
Start date
2025-01-01
Completion date
2025-07-30
Last updated
2025-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local Analgesia Via Infiltration, Wound Heal, Pain, Postoperative, Hemorrhage

Keywords

wound healing, free gingival graft, pain, dental anxiety, local anaesthesia

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.

Interventions

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.

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

FGG surgery was performed around natural teeth and implants where keratinized gingival tissue was inadequate.

Sponsors

Pamukkale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Intervention model description

prospective cross sectional study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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,

Design outcomes

Primary

MeasureTime frameDescription
early wound healing score (EHS)3rd day, 7th day, 14th dayThe 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

MeasureTime frameDescription
Ultrasonographic Evaluations3rd, 7th, and 14th daysAll 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026