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NCT Number: NCT07145879

Comparison of Postoperative Effects of Articaine and Lidocaine in Mucogingival Surgery

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.

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Key information

Conditions

Local Analgesia Via Infiltration Hemorrhage Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Wound Heal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University Faculty of Dentistry

Denizli, 20100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Lidocaine hydrochloride 2% with epinephrine 1:100 000

Drug

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.

Other names: free gingival graft

Articaine 4% with epinephrine 1:100,000

Drug

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

Other names: free gingival graft

Free Gingival Graft (FGG)

Procedure

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

Primary outcomes

  1. early wound healing score (EHS)

    Time frame: 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 outcomes

  1. Ultrasonographic Evaluations

    Time frame: 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.

  2. Modified Dental Anxiety Scale (MDAS)

    Time frame: 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

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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