Evaluation of Patients' Perceptions and Soft Tissue Changes After Conventional and Diode Laser Frenectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Necmettin Erbakan University
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Postoperative pain
Study Overview
Brief Summary
The goal of this clinical trial is to determine if diode laser treatment can improve post-operative outcomes compared to conventional scalpel technique in systemically healthy, non-smoking adults aged 18-45 years with aberrant papillary frenum attachment. The main questions it aims to answer are:
Does diode laser treatment result in lower post-operative pain compared to the conventional scalpel technique? Does diode laser treatment result in better periodontal healing outcomes compared to the conventional scalpel technique? Researchers will compare the diode laser surgery group to the conventional scalpel surgery group to see if there are differences in pain and healing.
Participants will:
Undergo a frenectomy procedure using either a diode laser or a conventional scalpel.
Receive oral hygiene instructions and post-operative care recommendations. Have their periodontal parameters measured at baseline, 6 weeks, and 6 months post-operation.
Record their pain levels using a visual analogue scale on specified post-operative days.
Detailed Description
The trial will be performed as a prospective, randomized and controlled, single-blind investigation to study clinical parameters and patients' experiences when performing a frenectomy, comparing diode laser treatment with the conventional scalpel technique.
Participants:
This study will include 43 participants who will be identified with aberrant papillary frenum attachment according to Mirko et al., and will be referred to the periodontology department. The inclusion criteria for the participants will be:
All participants will sign a written informed consent form before participating in the study.
Study Groups and Randomization:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Patients in the C group underwent primary wound healing with sutures, whereas patients in the L group did not get any sutures. Therefore, neither the clinicians (Z.T.E and K.Y) nor the patients were kept unaware of the study's details over the entire duration
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Systemically healthy
- •Nonsmoker
- •No periodontal treatment received in the last 3 months
- •Having at least 20 teeth
- •Presence of at least central incisors, lateral incisors, and canines in the maxilla
- •Not pregnant or breastfeeding
- •No psychiatric, mental, or physical impairments
- •Diagnosed with gingival health based on the "World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions
- •Consent to participate in the study.
Exclusion Criteria
- •Any systemic disease that could interfere with the wound healing process (e.g., diabetes mellitus and HIV infection)
- •Use of antibiotics, anti-inflammatory drugs, or any other medication in the last 6 months that could affect the study's outcome
- •Any hypersensitivity reactions to paracetamol
- •Any physical limitations or restrictions that could impede normal oral hygiene procedures.
Arms & Interventions
Control group (conventional scalpel surgery)
After administering local infiltrative anesthesia with articaine hydrochloric acid combined with epinephrine 1:100,000, the frenum will be grasped with a straight hemostat positioned in the vestibule. The tissue adjacent to the upper and lower surfaces of the hemostat will then be incised using a no.15 scalpel. The excised diamond-shaped portion of the frenum will be removed with the hemostat. Subsequently, a horizontal incision will be made on the periosteum with a scalpel to prevent fiber reattachment. The wound site will be primarily closed using absorbable sutures (4/0, Pegelak), which will be removed one week post-operatively.
Intervention: Control group (conventional scalpel surgery) (Procedure)
Diode laser group
The frenectomy procedure will be performed under local infiltrative anesthesia, specifically articaine hydrochloric acid with epinephrine 1:100,000. A straight hemostat, similar to that used in the C group, will be employed to secure the frenum. Laser energy will be applied to the upper and lower sections of the frenum adjacent to the hemostat, utilizing a diode laser device equipped with a 400 µm diameter, plain-ended optical fiber tip. Frenectomy will performed with a 980 nm diode laser with 1.7 W power in continuous wave mode.The wound site will be allowed to heal by secondary intention without the application of sutures.
Intervention: Diode laser group (Procedure)
Outcomes
Primary Outcomes
Postoperative pain
Time Frame: postoperative days 1, 3, 7, 14, 21, and 28.
Pain will be evaluated using the visual analogue scale (VAS).The scale will be comprised of a horizontal line with values ranging from '0' to '10', where '0' indicates the absence of pain and '10' indicates the presence of severe discomfort.
Postoperative tissue healing
Time Frame: postoperative days 7 and 30 after surgery,
Tissue healing will be assessed by Z.T.E using the following scoring system: * Score 1: Complete epithelialization * Score 2: Incomplete epithelialization * Score 3: Presence of ulcer * Score 4: Tissue defect or necrosis
Secondary Outcomes
No secondary outcomes reported
Investigators
Zeynep Tastan Eroglu
Assistant professor
Necmettin Erbakan University