Wound HealNCT05252260
Comparison of Diode Laser-Assisted Vestibuloplasty And Conventional Vestibuloplasty
A study testing Diode Laser, Conventional Surgery and Low level laser therapy (LLLT) in people with Wound Heal and Vestibular Abnormality, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Randomized controlled parallel designed clinical study aimed to compare vestibule depth gain and dimensional changes of wound area in individuals who underwent vestibule deepening surgery using diode laser and conventional technique Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Heal, Vestibular Abnormality, Low-level Light Therapy
- What is being tested?
- Diode Laser, Conventional Surgery and Low level laser therapy (LLLT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 23 Jun 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant Izzet Baysal University, Faculty of Dentistry, Department of Periodontology
Bolu, 14030
About this study
Official title: Comparison Of Diode Laser-Assisted Vestibuloplasty And Conventional Vestibuloplasty In Terms Of Wound Healing And Vestibular Depth Gain
Randomized controlled parallel designed clinical study aimed to compare vestibule depth gain and dimensional changes of wound area in individuals who underwent vestibule deepening surgery using diode laser and conventional technique
Read the 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.
- Being tested
- Diode Laser, Conventional Surgery, Low level laser therapy (LLLT)
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode LaserProcedure or surgery
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.
Conventional SurgeryProcedure or surgery
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.
Low level laser therapy (LLLT)Other
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
| Study group | Role | What they receive |
|---|---|---|
| Diode Laser | Experimental | Vestibuloplasty operation was performed via diode laser Receives: Procedure: Diode Laser |
| Diode laser + Low-level laser therapy | Other | Vestibuloplasty operation was performed via diode laser and following low-level laser therapy was applied Receives: Procedure: Diode Laser; Other: Low level laser therapy (LLLT) |
| Conventional surgery | Active comparator | Vestibuloplasty operation was performed via scalpel Receives: Procedure: Conventional Surgery |
| Conventional surgery + Low-level laser therapy | Other | Vestibuloplasty operation was performed via scalpel and following low-level laser therapy was applied Receives: Procedure: Conventional Surgery; Other: Low level laser therapy (LLLT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vestibule Depth Measurement Change (millimeter)
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
Measured: 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 outcomes (1)
Re-epithelization Area of the operation region
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Oct 2019
- Primary completion7 Jun 2020
- Study completion23 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadiye Gunpinar, Abant Izzet Baysal University
- Investigators
- Sadiye Gunpinar, Assoc. Prof, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252260
- Sponsor's protocol ID
- 2018/120
- Status last verified
- Feb 2022
- First submitted
- 2 Feb 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Diode Laser-Assisted Vestibuloplasty And Conventional Vestibuloplasty In Terms Of Wound Healing And Vestibular Depth Gain
- ClinicalTrials.gov ID
- NCT05252260
- Acronym / sponsor ID
- 2018/120
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 7 Jun 2020 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 23 Feb 2022 (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.
Randomized controlled parallel designed clinical study aimed to compare vestibule depth gain and dimensional changes of wound area in individuals who underwent vestibule deepening surgery using diode laser and conventional technique
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diode Laser | Experimental | Procedure: Diode LaserVestibuloplasty operation was performed via diode laser |
| Diode laser + Low-level laser therapy | Other | Procedure: Diode Laser, Other: Low level laser therapy (LLLT)Vestibuloplasty operation was performed via diode laser and following low-level laser therapy was applied |
| Conventional surgery | Active comparator | Procedure: Conventional SurgeryVestibuloplasty operation was performed via scalpel |
| Conventional surgery + Low-level laser therapy | Other | Procedure: Conventional Surgery, Other: Low level laser therapy (LLLT)Vestibuloplasty operation was performed via scalpel and following low-level laser therapy was applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Diode LaserVestibuloplasty 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. | Procedure or surgery | Diode Laser, Diode laser + Low-level laser therapy |
| Conventional SurgeryA 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. | Procedure or surgery | Conventional surgery, Conventional surgery + Low-level laser therapy |
| Low level laser therapy (LLLT)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 | Other | Conventional surgery + Low-level laser therapy, Diode laser + Low-level laser therapy |
Primary outcome
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
1 secondary outcome
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
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 23 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Sadiye Gunpinar, Assoc. Prof principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diode Laser, Conventional Surgery and Low level laser therapy (LLLT) in people with Wound Heal and Vestibular Abnormality, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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 23 Feb 2022. 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 Turkey (Türkiye). 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2022.