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Local Analgesia Via InfiltrationNCT07145879

Comparison of Postoperative Effects of Articaine and Lidocaine in Mucogingival Surgery

A study testing Lidocaine hydrochloride 2% with epinephrine 1:100 000, Articaine 4% with epinephrine 1:100,000 and Free gingival graft (FGG) in people with Local Analgesia Via Infiltration and Wound Heal, run by Pamukkale University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Lidocaine hydrochloride 2% with epinephrine 1:100 000, Articaine 4% with epinephrine 1:100,000 and Free gingival graft (FGG)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2025to 30 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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,

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Pamukkale University Faculty of Dentistry

    Denizli, 20100

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Lidocaine hydrochloride 2% with epinephrine 1:100 000, Articaine 4% with epinephrine 1:100,000, Free gingival graft (FGG)
Keywords
wound healing, free gingival graft, pain, dental anxiety, local anaesthesia
Medical subject headings
Pain, Postoperative, Hemorrhage, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lidocaine hydrochloride 2% with epinephrine 1:100 000Drug

    Also called free gingival graft

    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

    Also called free gingival graft

    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 or surgery

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

Study groups in NCT07145879
Study groupRoleWhat they receive
lidocaine HCLOtherParticipants will receive lidocaine HCL 2% with adrenaline for local anesthesia before free gingival surgery once only
Receives: Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000; Procedure: Free gingival graft (FGG)
articaine HCLOtherParticipants will receive articaine HCL 4% with adrenaline for local anestesia before free gingival surgery once only
Receives: Drug: Articaine 4% with epinephrine 1:100,000; Procedure: Free gingival graft (FGG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 3rd day, 7th day, 14th day

Secondary outcomes (3)

  1. 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.

    Measured: 3rd, 7th, and 14th days

  2. 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

    Measured: baseline and 14 days after the procedure,

  3. 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

    Measured: baseline and 14 days after the procedure,

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2025
  2. Study start1 Jan 2025
  3. Primary completion30 Jul 2025
  4. Study completion30 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Factorial
Model description
prospective cross sectional study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07145879
Sponsor's protocol ID
07.01.2025/01
Status last verified
Aug 2025
First submitted
14 Aug 2025
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: I can share it after my article is published if there is a valid reason.

Publications

  • 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.

    PubMed 29884529

  • 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.

  • 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.

    PubMed 23660127

  • 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.

    PubMed 36482533

Questions about this trial

What is this clinical trial studying?

A study testing Lidocaine hydrochloride 2% with epinephrine 1:100 000, Articaine 4% with epinephrine 1:100,000 and Free gingival graft (FGG) in people with Local Analgesia Via Infiltration and Wound Heal, run by Pamukkale University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

early wound healing score (EHS) (time frame: 3rd day, 7th day, 14th day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07145879, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.

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