NCT07462117

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2018

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

6.5 years

First QC Date

February 19, 2026

Last Update Submit

March 7, 2026

Conditions

Keywords

vestibuloplasty lasernarrow vestibule

Outcome Measures

Primary Outcomes (2)

  • pain and comfort

    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.

    days 1, 3, and 7 postoperatively

  • The vestibular gain depth

    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).

    6 weeks

Study Arms (3)

Nd -YAG vestibuloplasty group

ACTIVE COMPARATOR

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

Procedure: vestibuloplasty for Nd-YAG group

Diode laser vestibuloplasty group

ACTIVE COMPARATOR

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.

Procedure: diode vestibuloplasty

Er-YAG laservestibuloplasty group

ACTIVE COMPARATOR

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

Procedure: Er-YAG laser vestibuloplasty

Interventions

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.

Nd -YAG vestibuloplasty group

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

Diode laser vestibuloplasty group

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.

Er-YAG laservestibuloplasty group

Eligibility Criteria

Age62 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Systemically healthy 36 edentulous patients , We selected the patients to be candidates for total prostheses and complete edentulous at the level of the maxilla.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nica Diana

Timișoara, Romania

Location

MeSH Terms

Conditions

Mouth, EdentulousAtrophy

Interventions

Vestibuloplasty

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures, PreprostheticOral Surgical ProceduresSurgical Procedures, OperativeDentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

February 19, 2026

First Posted

March 10, 2026

Study Start

April 30, 2018

Primary Completion

October 20, 2024

Study Completion

October 20, 2024

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations