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Comparison of Diode Laser-Assisted Vestibuloplasty And Conventional Vestibuloplasty

Primary Purpose

Wound Heal, Vestibular Abnormality, Low-level Light Therapy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Diode Laser
Conventional Surgery
Low level laser therapy (LLLT)
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Heal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Other

Active Comparator

Other

Arm Label

Diode Laser

Diode laser + Low-level laser therapy

Conventional surgery

Conventional surgery + Low-level laser therapy

Arm Description

Vestibuloplasty operation was performed via diode laser

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

Vestibuloplasty operation was performed via scalpel

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Re-epithelization Area of the operation region
Areas where there is little or no gingival epithelium were evaluated by applying a plaque staining agent to the surgical area. Clinical photographs of the stained gingiva were taken immediately after the operation and on the 3rd, 7th, and 14th days after the operation, using pre-prepared acrylic stents. Images were taken at standard magnification and distance on a digital camera (four optical zooms, 20cm) and the head of each patient was positioned to standardize the images. Incomplete epithelialized areas were measured using an image analysis software by the investigator blinded to the groups

Full Information

First Posted
February 2, 2022
Last Updated
February 11, 2022
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT05252260
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
June 7, 2020 (Actual)
Study Completion Date
June 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal, Vestibular Abnormality, Low-level Light Therapy, Surgical Wound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diode Laser
Arm Type
Experimental
Arm Description
Vestibuloplasty operation was performed via diode laser
Arm Title
Diode laser + Low-level laser therapy
Arm Type
Other
Arm Description
Vestibuloplasty operation was performed via diode laser and following low-level laser therapy was applied
Arm Title
Conventional surgery
Arm Type
Active Comparator
Arm Description
Vestibuloplasty operation was performed via scalpel
Arm Title
Conventional surgery + Low-level laser therapy
Arm Type
Other
Arm Description
Vestibuloplasty operation was performed via scalpel and following low-level laser therapy was applied
Intervention Type
Procedure
Intervention Name(s)
Diode Laser
Intervention Description
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
Intervention Name(s)
Conventional Surgery
Intervention Description
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
Other
Intervention Name(s)
Low level laser therapy (LLLT)
Intervention Description
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
Primary Outcome Measure Information:
Title
Vestibule Depth Measurement Change (millimeter)
Description
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
Time Frame
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 Outcome Measure Information:
Title
Re-epithelization Area of the operation region
Description
Areas where there is little or no gingival epithelium were evaluated by applying a plaque staining agent to the surgical area. Clinical photographs of the stained gingiva were taken immediately after the operation and on the 3rd, 7th, and 14th days after the operation, using pre-prepared acrylic stents. Images were taken at standard magnification and distance on a digital camera (four optical zooms, 20cm) and the head of each patient was positioned to standardize the images. Incomplete epithelialized areas were measured using an image analysis software by the investigator blinded to the groups
Time Frame
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 Pre-specified Outcome Measures:
Title
Wound Healing Scores of the surgical area
Description
The healing of the surgical area was scored by using an index determined by Landry et al and compared between the groups in the evaluated time periods (1:worst and 5:excellent)
Time Frame
Wound healing scores on 3rd day, Wound healing scores on 7th day; Wound healing scores on 14th day; Wound healing scores on 28th day
Title
Pain and Loss of Function Scores of the study participants
Description
Patients were asked to rate their postoperative pain and functional changes (discomfort during eating and speaking) on visual analog scales (VAS) and compared between the groups in the evaluated time periods (1: minimum and 10: maximum). Minimum scores mean better results.
Time Frame
Pain and Loss of Function on 1st day; Pain and Loss of Function on 7th day after the operation
Title
Change in horizontal wound dimension in the surgical area
Description
The linear dimensions of the wound in the horizontal direction were measured with a digital caliper over the projection on the endodontic file and recorded on the patient form.
Time Frame
Change from Baseline horizontal dimension at 1 week; Change from Baseline horizontal dimension at 2 week; Change from Baseline horizontal dimension at 4 week
Title
Scar Tissue Formation Scores in the surgical area
Description
The scar tissue in the operation area was evaluated clinically and compared between the study groups (0: minimum scar formation; 8 maximum scar formation) minimum scar formation is better
Time Frame
Scar Tissue Formation at 1st month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sadiye Gunpinar, Assoc. Prof
Organizational Affiliation
Abant Izzet Baysal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bolu Abant Izzet Baysal University, Faculty of Dentistry, Department of Periodontology
City
Bolu
ZIP/Postal Code
14030
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Diode Laser-Assisted Vestibuloplasty And Conventional Vestibuloplasty

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