Clinical trial NCT05252260: Comparison of Diode Laser-Assisted Vestibuloplasty And Conventional Vestibuloplasty
Official title: Comparison Of Diode Laser-Assisted Vestibuloplasty And Conventional Vestibuloplasty In Terms Of Wound Healing And Vestibular Depth Gain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Vestibular Abnormality
Low-level Light Therapy
Surgical Wound
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled parallel designed clinical study aimed to compare vestibule depth gain and dimensional changes of wound area in individuals who underwent vestibule deepening surgery using diode laser and conventional technique

Detailed description: 52 systemically healthy patients aged between 18 and 53 years (10 males and 42 females) with inadequate vestibular depth and insufficient attached gingiva in the anterior mandible were included in this randomized examiner- and patient-blinded, parallel design study. Following nonsurgical periodontal treatment, patients were divided into 4 groups as follows: a) diode laser (L); b) diode laser+Low level laser therapy (LLLT); c) conventional surgery and conventional surgery+LLLT, and vestibule deepening was applied to all subjects either with scalpel or laser assisted.

Scalpel surgery was performed as Clark's vestibuloplasty. A local anesthetic was administered bilaterally to the mental area. Then, a horizontal incision was prepared at the mucogingival junction with a scalpel blade 15c. All the muscle fibers over the periosteum were resected carefully. Following, the mucosal flap was sutured to the depth of the vestibule sulcus with 4-0 polypropylene suture material, once every 4 mm, from a total of 5 regions.

Laser assisted vestibuloplasty was performed using diode laser. Local anesthesia was achieved in the same manner as the control group (scalpel surgery). Laser irradiation was performed in continuous wave mode, using a 980 nm diode laser with a power of 1.5W, 600 μm optical fiber. After adequate local anesthesia, ablation was started from the mucogingival junction and performed with horizontal movements parallel to the bone. The muscle attachments were slowly released until the deepest point of the wound site was 5 mm. The mucosal flap was not stabilized with sutures and periodontal dressing was not used to cover the wound area.

Eligibility criteria: Inclusion Criteria:

* Patients were\> 18 years old and of both genders,
* Patients presenting inadequate vestibular depth and insufficient attached gingiva on incisors in the mandibular anterior region
* Full mouth plaque index (PI) and gingival index (GI) scores \< 1
* The patients had to be systemically healthy and nonsmokers

Exclusion Criteria:

* Patients who had Miller class II and more advanced gingival recession in the region of the lower anterior incisors and interproximal attachment loss
* Patients who were taking medications that would interfere with the wound-healing process, pregnant or lactating women,
* Patients who had previously undergone periodontal surgery in the study area, who had orthodontic therapy and using fixed/removable dentures involving lower anterior teeth were excluded from the study.

Primary outcomes:
measure: Vestibule Depth Measurement Change (millimeter)
timeFrame: Change from Baseline vestibule depth measurement at 1 week; Change from Baseline vestibule depth measurement at 2 week; Change from Baseline vestibule depth measurement at 1 month
Secondary outcomes:
measure: Re-epithelization Area of the operation region
timeFrame: Change from baseline re-epithelization Area at 3 day; Change from baseline re-epithelization Area at 7 day; Change from baseline re-epithelization Area at 14 day
Other outcomes:
measure: Wound Healing Scores of the surgical area
timeFrame: Wound healing scores on 3rd day, Wound healing scores on 7th day; Wound healing scores on 14th day; Wound healing scores on 28th day
measure: Pain and Loss of Function Scores of the study participants
timeFrame: Pain and Loss of Function on 1st day; Pain and Loss of Function on 7th day after the operation
measure: Change in horizontal wound dimension in the surgical area
timeFrame: Change from Baseline horizontal dimension at 1 week; Change from Baseline horizontal dimension at 2 week; Change from Baseline horizontal dimension at 4 week
measure: Scar Tissue Formation Scores in the surgical area
timeFrame: Scar Tissue Formation at 1st month
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant Izzet Baysal University, Faculty of Dentistry, Department of Periodontology
Study officials:
affiliation: Abant Izzet Baysal University
name: Sadiye Gunpinar, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
References: