Clinical Trials Directory

Trials / Completed

CompletedNCT07462117

Comparison of Nd Yag, Diode and Er:YAG Lasers vs Scalpel in Preprosthetic Vestibuloplasty: Vestibular Depth Gain

Comparative Analysis of the Performance of Three Dental Lasers Versusthe Conventional Scalpeltechnique in Vestibuloplasty

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
36 (actual)
Sponsor
University of Medicine and Pharmacy "Victor Babes" Timisoara · Academic / Other
Sex
All
Age
62 Years – 79 Years
Healthy volunteers
Accepted

Summary

The aim of this study was to compare the clinical results obtained using the conventional approach versus the modern laser method, by recording postoperative results

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREvestibuloplasty for Nd-YAG groupFor 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.
PROCEDUREdiode vestibuloplastywe 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
PROCEDUREEr-YAG laser vestibuloplastyFor 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.

Timeline

Start date
2018-04-30
Primary completion
2024-10-20
Completion
2024-10-20
First posted
2026-03-10
Last updated
2026-03-10

Locations

1 site across 1 country: Romania

Source: ClinicalTrials.gov record NCT07462117. Inclusion in this directory is not an endorsement.