- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07462117
Comparison of Nd Yag, Diode and Er:YAG Lasers vs Scalpel in Preprosthetic Vestibuloplasty: Vestibular Depth Gain (78/30102018)
Comparative Analysis of the Performance of Three Dental Lasers Versusthe Conventional Scalpeltechnique in Vestibuloplasty
Study Overview
Status
Conditions
Detailed Description
The patients were divided in 3 equal groups and the vestibuloplasty was performed by conventional surgery on the right side and by laser for the left side of the maxilla. The former served as a Control group. There were utilized three types of lasers and consequently divided the patients in three observational study groups: for Group 1, the vestibuloplasty was performed by Nd-YAG laser, for Group 2 a diode laser was utilized , while Group 3 was treated with an Er-YAG laser.
An initial measurement of the vestibular depth was performed by using a millimeter markings William periodontal probe on three predetermined areas on each side: paramedian (next to the frenulum), antero-lateral (measured in the middle of the operated field), and lateral (at the most posterior place included in surgery). The measurements were performed 6 weeks postoperatively at the same levels as they were registered before surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Timișoara, Romania
- Nica Diana
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Systemically healthy 36 edentulous patients , We selected the patients to be candidates for total prostheses and complete edentulous at the level of the maxilla.
Exclusion Criteria: no comorbidities
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Nd -YAG vestibuloplasty group
12 patients treated for Group 1 using a Nd-YAG laser on the left side of the maxilla. The procedure was performed under local anesthesia to ensure patient comfort and cooperation. The parameters for the Nd-YAG laser (Lightwalke, Fotona, Slovenia) that was utilized for this procedure were: center wavelength of 1064 nm, output power of 4 W, frequency equal to 25 Hz, Micro Short Pulse (MSP) mode, sapphire fiber of 300 micrometers in diameter, power density equal to 6229 W/cm2. The right side was treated conventional using the scalpel. Clark's vestibuloplasty method was applied in all conventionally operated right sides of the patients |
For patients treated by Nd-YAG laser, the procedure was performed under local anesthesia .
The parameters for the Nd-YAG laser are: center wavelength of 1064 nm, output power of 4 W, frequency equal to 25 Hz, Micro Short Pulse (MSP) mode, sapphire fiber of 300 micrometers in diameter, power density equal to 6229 W/cm2.
Conventional vestibuloplasty was applied on the right side of the maxilla using Clark's method.
A horizontal incision was performed at the mucogingival junction.
The supraperiosteal dissection is performed and the muscles insertions were gradually dissected in an apical direction up to the desired vestibular depth.
The mucosa of the inner side of the lip was undermined and the pedicled mucosal flap was secured to the periosteum at the new vestibule depth by using a 4-0 absorbable suture .
The wound healed by second intention without any additional graft.
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Active Comparator: Diode laser vestibuloplasty group
12 patients treated for Group 2 where a diode laser was utilized.
for performing the left side of the maxilla.
we utilized the Epic X TM laser from Biolase, with a center wavelength of 940 nm and a pre-initiated tip, in a contact, continuous mode, with an output energy of 3 W. Surgery with the laser tip began at the mucogingival junction with a horizontal movement directing the laser parallel to the bone, and thus slowly releasing the muscle fibers towards the new vestibule depth.
The right side of the maxilla was performed by conventional surgery using Clark s method.
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we utilized the Epic X TM laser from Biolase, with a center wavelength of 940 nm and a pre-initiated tip, in a contact, continuous mode, with an output energy of 3 W. Ablation with the laser tip began at the mucogingival junction with a horizontal movement directing the laser parallel to the bone, and thus slowly releasing the muscle fibers towards the new vestibule depth.
The right side of the maxilla was treated by conventional vestibuloplasty, Clark s method
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Active Comparator: Er-YAG laservestibuloplasty group
12 patients treated for Group 3 where an Er-YAG laser was utilized to treat the left side of the maxilla.
The Er-YAG laser (Lightwalker, Fotona, Slovenia) was equipped with a H14 handpiece, characterized by the following parameters: center wavelength of 2940 nm, contact mode, long pulse, energy of 200 mJ, frequency equal to 20 Hz, power of 4 W, water 2, gas 2. The right side of the maxilla was performed by conventional surgery using Clark s method
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For the left side of the maxilla, we utilized an Er-YAG laser (Lightwalker, Fotona, Slovenia) equipped with a H14 handpiece, characterized by the following parameters: center wavelength of 2940 nm, contact mode, long pulse, energy of 200 mJ, frequency equal to 20 Hz, power of 4 W, water 2, gas 2. For the right side of the maxilla we applied conventional vestibuloplasty using Clark s method.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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pain and comfort
Time Frame: days 1, 3, and 7 postoperatively
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Pain and discomfort values were compared between the conventional surgery and the Nd:YAG laser, diode laser, and Er-YAG laser groups by using the Wilcoxon signed-rank test.
The laser-treated sides have shown statistically significant reductions in both pain and discomfort scores at all considered timepoints (p < 0.05), as presented in the following.
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days 1, 3, and 7 postoperatively
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The vestibular gain depth
Time Frame: 6 weeks
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Vestibular depth measurements were compared between the initial, the immediate postoperatively, and the 6-week postoperatively timepoints.
Paired sample t-tests or Wilcoxon tests were utilized, depending on distribution, to evaluate changes within each technique (i.e., conventional and lasers).
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6 weeks
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Collaborators and Investigators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 78/30.10.2018 rev 2025
- 78/30102018 (Registry Identifier: COMISIA DE ETICĂ A CERCETĂRII ŞTIINŢIFICE)
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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