Edentulous; Alveolar Process, Atrophy78/30102018NCT07462117
Comparison of Nd Yag, Diode and Er:YAG Lasers vs Scalpel in Preprosthetic Vestibuloplasty: Vestibular Depth Gain
A study testing vestibuloplasty for Nd-YAG group, diode vestibuloplasty and Er-YAG laser vestibuloplasty in people with Edentulous; Alveolar Process, Atrophy and Healthy Adult Participants, run by University of Medicine and Pharmacy "Victor Babes" Timisoara at 1 site in Romania.
Trial 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 Read more about this study
- Who is it for?
- Ages 62 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous; Alveolar Process, Atrophy, Healthy Adult Participants, Edentulous Alveolar Ridge With Labial Resorption
- What is being tested?
- vestibuloplasty for Nd-YAG group, diode vestibuloplasty and Er-YAG laser vestibuloplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteRomania
- Study dates
- 30 Apr 2018to 20 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 62 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systemically healthy 36 edentulous patients , We selected the patients to be candidates for total prostheses and complete edentulous at the level of the maxilla.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Analysis of the Performance of Three Dental Lasers Versusthe Conventional Scalpeltechnique in Vestibuloplasty
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
Read the 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
- Edentulous; Alveolar Process, Atrophy, Healthy Adult Participants, Edentulous Alveolar Ridge With Labial Resorption
- Being tested
- vestibuloplasty for Nd-YAG group, diode vestibuloplasty, Er-YAG laser vestibuloplasty
- Keywords
- vestibuloplasty laser, narrow vestibule
- Medical subject headings
- Mouth, Edentulous, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vestibuloplasty for Nd-YAG groupProcedure or surgery
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.
diode vestibuloplastyProcedure or surgery
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
Er-YAG laser vestibuloplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: Procedure: Er-YAG laser vestibuloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start30 Apr 2018
- Primary completion20 Oct 2024
- Study completion20 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Edentulous; Alveolar Process, AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy "Victor Babes" Timisoara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nica Diana Florina, University of Medicine and Pharmacy "Victor Babes" Timisoara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462117
- Sponsor's protocol ID
- 78/30.10.2018 rev 2025
- Other IDs
- 78/30102018
- Acronym
- 78/30102018
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nica DF, Roi CI, Rivis M, Duma VF, Sinescu C, Negrutiu ML, Popoiu TA, Langa MC, Zaharia C. Preprosthetic vestibuloplasty performed by three different types of lasers versus conventional scalpel. Front Oral Health. 2026 Sep 4;7:1936637. doi: 10.3389/froh.2026.1936637. eCollection 2026.
PubMed 42761070
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of the Performance of Three Dental Lasers Versusthe Conventional Scalpeltechnique in Vestibuloplasty
- ClinicalTrials.gov ID
- NCT07462117
- Acronym / sponsor ID
- 78/30102018 / 78/30.10.2018 rev 2025
- Conditions
- Edentulous; Alveolar Process, Atrophy, Healthy Adult Participants, Edentulous Alveolar Ridge With Labial Resorption
- Keywords
- vestibuloplasty laser, narrow vestibule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy "Victor Babes" TimisoaraUniversity, hospital or other
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nd -YAG vestibuloplasty group | Active comparator | Procedure: vestibuloplasty for Nd-YAG group12 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 |
| Diode laser vestibuloplasty group | Active comparator | Procedure: diode vestibuloplasty12 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. |
| Er-YAG laservestibuloplasty group | Active comparator | Procedure: Er-YAG laser vestibuloplasty12 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 |
Who may qualify
- Ages
- 62 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Systemically healthy 36 edentulous patients , We selected the patients to be candidates for total prostheses and complete edentulous at the level of the maxilla.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vestibuloplasty 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. | Procedure or surgery | Nd -YAG vestibuloplasty group |
| diode 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 | Procedure or surgery | Diode laser vestibuloplasty group |
| Er-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. | Procedure or surgery | Er-YAG laservestibuloplasty group |
Primary outcome
pain and comfort
Time frame: days 1, 3, and 7 postoperatively
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.
The vestibular gain depth
Time frame: 6 weeks
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Derived from this study: PubMed 42761070Nica DF, Roi CI, Rivis M, Duma VF, Sinescu C, Negrutiu ML, Popoiu TA, Langa MC, Zaharia C. Preprosthetic vestibuloplasty performed by three different types of lasers versus conventional scalpel. Front Oral Health. 2026 Sep 4;7:1936637. doi: 10.3389/froh.2026.1936637. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vestibuloplasty for Nd-YAG group, diode vestibuloplasty and Er-YAG laser vestibuloplasty in people with Edentulous; Alveolar Process, Atrophy and Healthy Adult Participants, run by University of Medicine and Pharmacy "Victor Babes" Timisoara at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain and comfort (time frame: days 1, 3, and 7 postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07462117, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.