Differences in Soft Tissue Healing and Vascularization Between Articaine and Lidocaine: A Randomized Clinical and Ultrasonographic Study
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pamukkale University
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- early wound healing score (EHS)
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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,
Arms & Interventions
lidocaine HCL
Participants will receive lidocaine HCL 2% with adrenaline for local anesthesia before free gingival surgery once only
Intervention: Free gingival graft (FGG) (Procedure)
articaine HCL
Participants will receive articaine HCL 4% with adrenaline for local anestesia before free gingival surgery once only
Intervention: Free gingival graft (FGG) (Procedure)
Outcomes
Primary Outcomes
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
- 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,)
Investigators
AYSAN LEKTEMUR ALPAN
Head of Periodontology Department
Pamukkale University