Comparison of Diode Laser-Assisted Vestibuloplasty And Conventional Vestibuloplasty

NCT ID: NCT05252260

Last Updated: 2022-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2020-06-23

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.

Conditions

Wound Heal; Vestibular Abnormality; Low-level Light Therapy; Surgical Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Diode Laser

Vestibuloplasty operation was performed via diode laser

Group Type: EXPERIMENTAL

Diode Laser

Intervention Type: PROCEDURE

Vestibuloplasty surgery was performed via diode laser. Laser irradiation was performed in continuous wave mode, using a 980 nm diode laser with a power of 1.5W, 600 μm optical fiber.

Diode laser + Low-level laser therapy

Vestibuloplasty operation was performed via diode laser and following low-level laser therapy was applied

Group Type: OTHER

Diode Laser

Intervention Type: PROCEDURE

Vestibuloplasty surgery was performed via diode laser. Laser irradiation was performed in continuous wave mode, using a 980 nm diode laser with a power of 1.5W, 600 μm optical fiber.

Low level laser therapy (LLLT)

Intervention Type: OTHER

Vestibuloplasty surgery was performed via diode laser. Following, LLLT was applied in continuous wave mode for 1 minute without contacting the tissue, using a phototherapy probe (power output, 0.5W; total energy of 6 J / cm²) at a distance of 1-2 mm from the tissue. LLLT was repeated immediately after the surgery, on the 1st, 3rd and 7th days

Conventional surgery

Vestibuloplasty operation was performed via scalpel

Group Type: ACTIVE_COMPARATOR

Conventional Surgery

Intervention Type: PROCEDURE

A local anesthetic was administered bilaterally to the mental area and waited for 5 min for diffusion of the solution. Then, a horizontal incision was prepared at the mucogingival junction with a scalpel blade no. 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.

Conventional surgery + Low-level laser therapy

Vestibuloplasty operation was performed via scalpel and following low-level laser therapy was applied

Group Type: OTHER

Conventional Surgery

Intervention Type: PROCEDURE

A local anesthetic was administered bilaterally to the mental area and waited for 5 min for diffusion of the solution. Then, a horizontal incision was prepared at the mucogingival junction with a scalpel blade no. 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.

Low level laser therapy (LLLT)

Intervention Type: OTHER

Vestibuloplasty surgery was performed via diode laser. Following, LLLT was applied in continuous wave mode for 1 minute without contacting the tissue, using a phototherapy probe (power output, 0.5W; total energy of 6 J / cm²) at a distance of 1-2 mm from the tissue. LLLT was repeated immediately after the surgery, on the 1st, 3rd and 7th days

Interventions

Diode Laser

Vestibuloplasty surgery was performed via diode laser. Laser irradiation was performed in continuous wave mode, using a 980 nm diode laser with a power of 1.5W, 600 μm optical fiber.

Intervention Type: PROCEDURE

Conventional Surgery

A local anesthetic was administered bilaterally to the mental area and waited for 5 min for diffusion of the solution. Then, a horizontal incision was prepared at the mucogingival junction with a scalpel blade no. 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.

Intervention Type: PROCEDURE

Low level laser therapy (LLLT)

Vestibuloplasty surgery was performed via diode laser. Following, LLLT was applied in continuous wave mode for 1 minute without contacting the tissue, using a phototherapy probe (power output, 0.5W; total energy of 6 J / cm²) at a distance of 1-2 mm from the tissue. LLLT was repeated immediately after the surgery, on the 1st, 3rd and 7th days

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Sadiye Gunpinar

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sadiye Gunpinar, Assoc. Prof

Role: PRINCIPAL_INVESTIGATOR

Abant Izzet Baysal University

Locations

Bolu Abant Izzet Baysal University, Faculty of Dentistry, Department of Periodontology

Bolu, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2018/120

Identifier Type: -

Identifier Source: org_study_id