Comparison of Diode Laser-Assisted Vestibuloplasty And Conventional Vestibuloplasty

NCT05252260 | Completed DMC

• 1 other identifier: 2018/120
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Vestibule Depth Measurement Change (millimeter)

  Measurements were performed with the help of a plastic stopper placed on the endodontic canal instrument, with reference to the guides created on the acrylic stent which was prepared before the surgery

  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 (1)

• Re-epithelization Area of the operation region

  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 (4)

• Wound Healing Scores of the surgical area

  Wound healing scores on 3rd day, Wound healing scores on 7th day; Wound healing scores on 14th day; Wound healing scores on 28th day

• Pain and Loss of Function Scores of the study participants

  Pain and Loss of Function on 1st day; Pain and Loss of Function on 7th day after the operation

• Change in horizontal wound dimension in the surgical area

  Change from Baseline horizontal dimension at 1 week; Change from Baseline horizontal dimension at 2 week; Change from Baseline horizontal dimension at 4 week

Study Arms (4)

Diode Laser

EXPERIMENTAL

Vestibuloplasty operation was performed via diode laser

Procedure: Diode Laser

Diode laser + Low-level laser therapy

OTHER

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

Procedure: Diode Laser; Other: Low level laser therapy (LLLT)

Conventional surgery

ACTIVE COMPARATOR

Vestibuloplasty operation was performed via scalpel

Procedure: Conventional Surgery

Conventional surgery + Low-level laser therapy

OTHER

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

Procedure: Conventional Surgery; Other: Low level laser therapy (LLLT)

Interventions

Diode Laser 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; Diode laser + Low-level laser therapy

Conventional Surgery 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; Conventional surgery + Low-level laser therapy

Low level laser therapy (LLLT) 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 + Low-level laser therapy; Diode laser + Low-level laser therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

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

Bolu, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Surgical Wound

Interventions

Lasers, Semiconductor; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Sadiye Gunpinar, Assoc. Prof

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 23, 2022
• Study Start: October 1, 2019
• Primary Completion: June 7, 2020
• Study Completion: June 23, 2020
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)