Comparison of Postoperative Effects of Articaine and Lidocaine in Mucogingival Surgery

NCT07145879 | Completed DMC

• 1 other identifier: 07.01.2025/01
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

  3rd day, 7th day, 14th day

Secondary Outcomes (3)

• Ultrasonographic Evaluations

  3rd, 7th, and 14th days

• Modified Dental Anxiety Scale (MDAS)

  baseline and 14 days after the procedure,

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

  baseline and 14 days after the procedure,

Study Arms (2)

lidocaine HCL

OTHER

Participants will receive lidocaine HCL 2% with adrenaline for local anesthesia before free gingival surgery once only

Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000; Procedure: Free gingival graft (FGG)

articaine HCL

OTHER

Participants will receive articaine HCL 4% with adrenaline for local anestesia before free gingival surgery once only

Drug: Articaine 4% with epinephrine 1:100,000; Procedure: Free gingival graft (FGG)

Interventions

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.

Also known as: free gingival graft

lidocaine HCL

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

Also known as: free gingival graft

articaine HCL

Free gingival graft (FGG) PROCEDURE

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

articaine HCL; lidocaine HCL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University Faculty of Dentistry

Denizli, 20100, Turkey (Türkiye)

Location

Related Publications (4)

• Kesici S, Kesici U, Ulusoy H, Erturkuner P, Turkmen A, Arda O. [Effects of local anesthetics on wound healing]. Braz J Anesthesiol. 2018 Jul-Aug;68(4):375-382. doi: 10.1016/j.bjan.2018.01.016. Epub 2018 Jun 6.

  PMID: 29884529 BACKGROUND

• Al-Saffar, M.T., A.S. Mahmood, and M.S. Sulaiman, Impact of Local Anesthesia on Wound Healing. Indian Journal of Forensic Medicine & Toxicology, 2020. 14(4): p. 1869-1874.

  BACKGROUND

• Giovannitti JA Jr, Rosenberg MB, Phero JC. Pharmacology of local anesthetics used in oral surgery. Oral Maxillofac Surg Clin North Am. 2013 Aug;25(3):453-65, vi. doi: 10.1016/j.coms.2013.03.003. Epub 2013 May 7.

  PMID: 23660127 BACKGROUND

• Luo W, Zheng K, Kuang H, Li Z, Wang J, Mei J. The potential of articaine as new generation of local anesthesia in dental clinics: A review. Medicine (Baltimore). 2022 Dec 2;101(48):e32089. doi: 10.1097/MD.0000000000032089.

  PMID: 36482533 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Hemorrhage; Pain

Interventions

Lidocaine; Epinephrine; Carticaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Aysan Lektemur Alpan, PhD DDS

  Pamukkale University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Periodontology Department

Model Details: prospective cross sectional study

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 28, 2025
• Study Start: January 1, 2025
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)