- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05252260
Comparison of Diode Laser-Assisted Vestibuloplasty And Conventional Vestibuloplasty
Comparison Of Diode Laser-Assisted Vestibuloplasty And Conventional Vestibuloplasty In Terms Of Wound Healing And Vestibular Depth Gain
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Bolu, Turkey, 14030
- Bolu Abant Izzet Baysal University, Faculty of Dentistry, Department of Periodontology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Diode Laser
Vestibuloplasty operation was performed via 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.
|
OTHER: Diode laser + Low-level laser therapy
Vestibuloplasty operation was performed via diode laser and following low-level laser therapy was applied
|
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.
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
|
ACTIVE_COMPARATOR: Conventional surgery
Vestibuloplasty operation was performed via scalpel
|
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.
|
OTHER: Conventional surgery + Low-level laser therapy
Vestibuloplasty operation was performed via scalpel and following low-level laser therapy was applied
|
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
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vestibule Depth Measurement Change (millimeter)
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
|
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
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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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Re-epithelization Area of the operation region
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
|
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
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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
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound Healing Scores of the surgical area
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
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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)
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Wound healing scores on 3rd day, Wound healing scores on 7th day; Wound healing scores on 14th day; Wound healing scores on 28th day
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Pain and Loss of Function Scores of the study participants
Time Frame: Pain and Loss of Function on 1st day; Pain and Loss of Function on 7th day after the operation
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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.
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Pain and Loss of Function on 1st day; Pain and Loss of Function on 7th day after the operation
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Change in horizontal wound dimension in the surgical area
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
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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.
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Change from Baseline horizontal dimension at 1 week; Change from Baseline horizontal dimension at 2 week; Change from Baseline horizontal dimension at 4 week
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Scar Tissue Formation Scores in the surgical area
Time Frame: Scar Tissue Formation at 1st month
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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
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Scar Tissue Formation at 1st month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sadiye Gunpinar, Assoc. Prof, Abant Izzet Baysal University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/120
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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