Maxillary Labial Frenulum AbnormalityMLF-DL-KRYONCT07708389
970-nm Diode Laser Versus Liquid Nitrogen Cryotherapy in Maxillary Labial Frenectomy
A study testing 970-nm Diode Laser Frenectomy and Liquid Nitrogen Cryotherapy in people with Maxillary Labial Frenulum Abnormality and Hypertrophic Maxillary Labial Frenulum, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, single-blind, assessor-blinded, parallel-group clinical trial aims to compare the effects of 970-nm diode laser and liquid nitrogen cryotherapy in patients requiring maxillary labial frenectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Maxillary Labial Frenulum Abnormality, Hypertrophic Maxillary Labial Frenulum
- What is being tested?
- 970-nm Diode Laser Frenectomy and Liquid Nitrogen Cryotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 21 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years.
- Systemically healthy, ASA I status.
- Clinical indication for maxillary labial frenectomy.
- Ability to attend postoperative follow-up visits.
- Provision of written informed consent.
Who cannot join
- Systemic or local corticosteroid use within the last 6 months.
- Endocrine disease that may affect cortisol levels.
- Pregnancy or lactation.
- Active oral infection.
- Chronic analgesic or anti-inflammatory drug use.
- Psychiatric medication use.
Show all 10Show fewer
- Smoking.
- ASA II or higher systemic status.
- Inability to attend follow-up visits.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kutahya Health Sciences University Faculty of Dentistry
Kütahya, Kütahya, 43020
Muhammet Yasin Pektaş, Asst. Prof., DDS, +905541351195, muhammetyasin.pektas@ksbu.edu.tr
mypektas42@gmail.com
About this study
Official title: Comparison of Salivary Cortisol Response and Early Postoperative Outcomes Following 970-nm Diode Laser and Liquid Nitrogen Cryotherapy in Maxillary Labial Frenectomy: A Randomized Single-Blind Clinical Trial
This prospective, randomized, single-blind, assessor-blinded, parallel-group clinical trial aims to compare the effects of 970-nm diode laser and liquid nitrogen cryotherapy in patients requiring maxillary labial frenectomy.
The primary objective is to compare the change in salivary cortisol levels from baseline to postoperative day 2 between the two treatment groups. Secondary objectives include comparison of postoperative pain, edema, interincisal mouth opening, analgesic consumption, operation duration, state anxiety, clinical wound healing, and adverse events.
Eligible adult patients with an indication for maxillary labial frenectomy will be randomly assigned to receive either 970-nm diode laser frenectomy or liquid nitrogen cryotherapy. Salivary cortisol samples and clinical outcomes will be assessed during the early postoperative follow-up period.
Read the detailed description
Maxillary labial frenulum abnormalities may be associated with diastema, plaque accumulation, periodontal irritation, gingival recession, oral hygiene difficulty, functional discomfort, and esthetic concerns. Frenectomy may be indicated when the frenulum is hypertrophic, short, thick, or inserted close to the interdental papilla.
Conventional scalpel frenectomy is effective but may be associated with intraoperative bleeding, need for suturing, postoperative pain, edema, and reduced patient comfort. Minimally invasive approaches such as diode laser surgery and cryotherapy may offer potential advantages in oral soft tissue procedures.
This study will compare two minimally invasive approaches for maxillary labial frenectomy: 970-nm diode laser and liquid nitrogen cryotherapy. Participants will be randomized into two parallel groups. In the diode laser group, frenectomy will be performed using a 970-nm diode laser at 2 W in continuous wave mode with a 320-micrometer sterile fiber tip using a contact technique. In the liquid nitrogen cryotherapy group, open-spray cryotherapy will be applied to the maxillary labial frenulum region with two freeze-thaw cycles.
The primary endpoint is the change in salivary cortisol level from baseline to postoperative day 2. Secondary endpoints include postoperative day 7 salivary cortisol change, postoperative pain measured by visual analog scale, edema, interincisal mouth opening, total analgesic consumption, operation duration, State-Trait Anxiety Inventory-State score, Landry, Turnbull and Howley wound healing index scores, and postoperative complications or adverse events.
All procedures and salivary sampling will be standardized and performed in the morning to reduce the influence of circadian variation on cortisol measurements. The study will be conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Kutahya Health Sciences University.
- Being tested
- 970-nm Diode Laser Frenectomy, Liquid Nitrogen Cryotherapy
- Keywords
- Maxillary labial frenectomy, Diode laser, 970-nm diode laser, Liquid nitrogen cryotherapy, Salivary cortisol, Postoperative pain, Wound healing
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
970-nm Diode Laser FrenectomyProcedure or surgery
Also called Diode laser frenectomy
Maxillary labial frenectomy will be performed using a 970-nm diode laser device at 2 W power in continuous wave mode with a 320-micrometer sterile fiber tip using a contact technique. The total laser application time will be standardized as 2 minutes. The surgical area will not be sutured and will be left to heal by secondary intention.
Liquid Nitrogen CryotherapyProcedure or surgery
Liquid nitrogen cryotherapy will be applied to the maxillary labial frenulum region using an open-spray technique. Two freeze-thaw cycles will be performed; each freezing cycle will last 15 seconds, with passive complete thawing between cycles. No mechanical excision will be performed after cryotherapy, and the surgical area will not be sutured.
| Study group | Role | What they receive |
|---|---|---|
| 970-nm Diode Laser Frenectomy | Experimental | Participants randomized to this arm will undergo maxillary labial frenectomy using a 970-nm diode laser. The procedure will be performed with a SiroLaser Advance device at 970 nm wavelength, 2 W power, continuous wave mode, and a 320-micrometer sterile fiber tip using a contact technique. The total laser application time will be standardized as 2 minutes. The surgical area will not be sutured and will be left to heal by secondary intention. Receives: Procedure: 970-nm Diode Laser Frenectomy |
| Liquid Nitrogen Cryotherapy | Experimental | Participants randomized to this arm will receive liquid nitrogen cryotherapy applied to the maxillary labial frenulum region using an open-spray technique. Two freeze-thaw cycles will be performed; each freezing cycle will last 15 seconds, with passive complete thawing between cycles. No mechanical excision will be performed after cryotherapy. The target tissue is expected to be eliminated through cryogenic necrosis and secondary healing. The surgical area will not be sutured. Receives: Procedure: Liquid Nitrogen Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in salivary cortisol level from baseline to postoperative day 2
Salivary cortisol will be measured in unstimulated saliva samples using an ELISA method. For each participant, the change in salivary cortisol level from the preoperative baseline measurement to postoperative day 2 will be calculated and compared between the two intervention groups. Results will be recorded in nmol/L.
Measured: Baseline and postoperative day 2
Secondary outcomes (9)
Change in salivary cortisol level from baseline to postoperative day 7
Salivary cortisol will be measured in unstimulated saliva samples using an ELISA method. For each participant, the change in salivary cortisol level from the preoperative baseline measurement to postoperative day 7 will be calculated and compared between the two intervention groups. Results will be recorded in nmol/L.
Measured: Baseline and postoperative day 7
Change in postoperative edema
Postoperative edema will be assessed using standardized facial measurements. Changes in edema measurements from baseline to postoperative day 2 and postoperative day 7 will be calculated and compared between the two intervention groups.
Measured: Baseline, postoperative day 2, and postoperative day 7
Postoperative pain intensity
Postoperative pain intensity will be assessed using a 0-to-10 visual analog scale, where higher scores indicate greater pain intensity.
Measured: Postoperative 6 hours, 12 hours, 24 hours, day 2, and day 7
Change in interincisal mouth opening
Interincisal mouth opening will be measured in millimeters. Changes from baseline to postoperative day 2 and postoperative day 7 will be calculated and compared between the two intervention groups.
Measured: Baseline, postoperative day 2, and postoperative day 7
Total analgesic consumption during the first postoperative week
Analgesic consumption will be recorded as the total number of analgesic tablets used by each participant during the first postoperative week.
Measured: Postoperative days 0 to 7
Operation duration
Operation duration will be recorded in minutes for each participant and compared between the two intervention groups.
Measured: During the intervention procedure
State anxiety score
State anxiety will be assessed using the State-Trait Anxiety Inventory-State form. Total scores will be recorded preoperatively and on postoperative days 2 and 7, and compared between the two intervention groups.
Measured: Baseline, postoperative day 2, and postoperative day 7
Clinical wound healing score
Clinical wound healing will be assessed using the Landry, Turnbull and Howley Wound Healing Index. Wound healing scores will be recorded on postoperative days 2, 7, 14, and 21 and compared between the two intervention groups.
Measured: Postoperative days 2, 7, 14, and 21
Postoperative complications and adverse events
The occurrence of postoperative complications or adverse events, including unexpected pain, bleeding, infection, wound healing problems, or other procedure-related adverse events, will be recorded during the follow-up period.
Measured: From the intervention procedure through postoperative day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completion2 May 2027 (estimated)
- Study completion21 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Maxillary Labial Frenulum AbnormalityStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- Model description
- Participants will be randomized into two parallel intervention groups: 970-nm diode laser frenectomy and liquid nitrogen cryotherapy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammet Yasin Pektaş, Asst. Prof, DDS, Principal investigator, Kutahya Health Sciences University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708389
- Sponsor's protocol ID
- MLF-DL-KRYO-2026-01
- Acronym
- MLF-DL-KRYO
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Opaleye T, Okoturo E, Adesina OA, Oyapero A, Salami Y, Wemambu JC. Salivary Cortisol as a Stress Monitor During Third Molar Surgery. J Maxillofac Oral Surg. 2022 Dec;21(4):1112-1118. doi: 10.1007/s12663-020-01480-2. Epub 2020 Nov 22.
PubMed 36896050Georgakopoulou E, Loumou P, Sgouros D, Chaurasia A, Panagiotopoulos A. Cryosurgery in oral lesions. J Clin Exp Dent. 2025 Oct 1;17(10):e1257-e1266. doi: 10.4317/jced.63133. eCollection 2025 Oct.
PubMed 41255399Sobouti F, Moallem Savasari A, Aryana M, Hakimiha N, Dadgar S. Maxillary labial frenectomy: a randomized, controlled comparative study of two blue (445 nm) and infrared (980 nm) diode lasers versus surgical scalpel. BMC Oral Health. 2024 Jul 25;24(1):843. doi: 10.1186/s12903-024-04364-w.
PubMed 39054510
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Salivary Cortisol Response and Early Postoperative Outcomes Following 970-nm Diode Laser and Liquid Nitrogen Cryotherapy in Maxillary Labial Frenectomy: A Randomized Single-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT07708389
- Acronym / sponsor ID
- MLF-DL-KRYO / MLF-DL-KRYO-2026-01
- Keywords
- Maxillary labial frenectomy, Diode laser, 970-nm diode laser, Liquid nitrogen cryotherapy, Salivary cortisol, Postoperative pain, Wound healing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 2 May 2027 (estimated)
- Study completion
- 21 May 2027 (estimated)
- First posted
- 16 Jul 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.
This prospective, randomized, single-blind, assessor-blinded, parallel-group clinical trial aims to compare the effects of 970-nm diode laser and liquid nitrogen cryotherapy in patients requiring maxillary labial frenectomy.
The primary objective is to compare the change in salivary cortisol levels from baseline to postoperative day 2 between the two treatment groups. Secondary objectives include comparison of postoperative pain, edema, interincisal mouth opening, analgesic consumption, operation duration, state anxiety, clinical wound healing, and adverse events.
Eligible adult patients with an indication for maxillary labial frenectomy will be randomly assigned to receive either 970-nm diode laser frenectomy or liquid nitrogen cryotherapy. Salivary cortisol samples and clinical outcomes will be assessed during the early postoperative follow-up period.
Detailed description
Maxillary labial frenulum abnormalities may be associated with diastema, plaque accumulation, periodontal irritation, gingival recession, oral hygiene difficulty, functional discomfort, and esthetic concerns. Frenectomy may be indicated when the frenulum is hypertrophic, short, thick, or inserted close to the interdental papilla.
Conventional scalpel frenectomy is effective but may be associated with intraoperative bleeding, need for suturing, postoperative pain, edema, and reduced patient comfort. Minimally invasive approaches such as diode laser surgery and cryotherapy may offer potential advantages in oral soft tissue procedures.
This study will compare two minimally invasive approaches for maxillary labial frenectomy: 970-nm diode laser and liquid nitrogen cryotherapy. Participants will be randomized into two parallel groups. In the diode laser group, frenectomy will be performed using a 970-nm diode laser at 2 W in continuous wave mode with a 320-micrometer sterile fiber tip using a contact technique. In the liquid nitrogen cryotherapy group, open-spray cryotherapy will be applied to the maxillary labial frenulum region with two freeze-thaw cycles.
The primary endpoint is the change in salivary cortisol level from baseline to postoperative day 2. Secondary endpoints include postoperative day 7 salivary cortisol change, postoperative pain measured by visual analog scale, edema, interincisal mouth opening, total analgesic consumption, operation duration, State-Trait Anxiety Inventory-State score, Landry, Turnbull and Howley wound healing index scores, and postoperative complications or adverse events.
All procedures and salivary sampling will be standardized and performed in the morning to reduce the influence of circadian variation on cortisol measurements. The study will be conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Kutahya Health Sciences University.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into two parallel intervention groups: 970-nm diode laser frenectomy and liquid nitrogen cryotherapy.
| Arm | Type | Receives |
|---|---|---|
| 970-nm Diode Laser Frenectomy | Experimental | Procedure: 970-nm Diode Laser FrenectomyParticipants randomized to this arm will undergo maxillary labial frenectomy using a 970-nm diode laser. The procedure will be performed with a SiroLaser Advance device at 970 nm wavelength, 2 W power, continuous wave mode, and a 320-micrometer sterile fiber tip using a contact technique. The total laser application time will be standardized as 2 minutes. The surgical area will not be sutured and will be left to heal by secondary intention. |
| Liquid Nitrogen Cryotherapy | Experimental | Procedure: Liquid Nitrogen CryotherapyParticipants randomized to this arm will receive liquid nitrogen cryotherapy applied to the maxillary labial frenulum region using an open-spray technique. Two freeze-thaw cycles will be performed; each freezing cycle will last 15 seconds, with passive complete thawing between cycles. No mechanical excision will be performed after cryotherapy. The target tissue is expected to be eliminated through cryogenic necrosis and secondary healing. The surgical area will not be sutured. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years.
- Systemically healthy, ASA I status.
- Clinical indication for maxillary labial frenectomy.
- Ability to attend postoperative follow-up visits.
- Provision of written informed consent.
Key exclusion criteria (10 listed)
- Systemic or local corticosteroid use within the last 6 months.
- Endocrine disease that may affect cortisol levels.
- Pregnancy or lactation.
- Active oral infection.
- Chronic analgesic or anti-inflammatory drug use.
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 |
|---|---|---|
| 970-nm Diode Laser FrenectomyAlso: Diode laser frenectomyMaxillary labial frenectomy will be performed using a 970-nm diode laser device at 2 W power in continuous wave mode with a 320-micrometer sterile fiber tip using a contact technique. The total laser application time will be standardized as 2 minutes. The surgical area will not be sutured and will be left to heal by secondary intention. | Procedure or surgery | 970-nm Diode Laser Frenectomy |
| Liquid Nitrogen CryotherapyLiquid nitrogen cryotherapy will be applied to the maxillary labial frenulum region using an open-spray technique. Two freeze-thaw cycles will be performed; each freezing cycle will last 15 seconds, with passive complete thawing between cycles. No mechanical excision will be performed after cryotherapy, and the surgical area will not be sutured. | Procedure or surgery | Liquid Nitrogen Cryotherapy |
Primary outcome
Change in salivary cortisol level from baseline to postoperative day 2
Time frame: Baseline and postoperative day 2
Salivary cortisol will be measured in unstimulated saliva samples using an ELISA method. For each participant, the change in salivary cortisol level from the preoperative baseline measurement to postoperative day 2 will be calculated and compared between the two intervention groups. Results will be recorded in nmol/L.
9 secondary outcomes
Change in salivary cortisol level from baseline to postoperative day 7
Time frame: Baseline and postoperative day 7
Change in postoperative edema
Time frame: Baseline, postoperative day 2, and postoperative day 7
Postoperative pain intensity
Time frame: Postoperative 6 hours, 12 hours, 24 hours, day 2, and day 7
Change in interincisal mouth opening
Time frame: Baseline, postoperative day 2, and postoperative day 7
Total analgesic consumption during the first postoperative week
Time frame: Postoperative days 0 to 7
Operation duration
Time frame: During the intervention procedure
State anxiety score
Time frame: Baseline, postoperative day 2, and postoperative day 7
Clinical wound healing score
Time frame: Postoperative days 2, 7, 14, and 21
Postoperative complications and adverse events
Time frame: From the intervention procedure through postoperative day 21
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 36896050Opaleye T, Okoturo E, Adesina OA, Oyapero A, Salami Y, Wemambu JC. Salivary Cortisol as a Stress Monitor During Third Molar Surgery. J Maxillofac Oral Surg. 2022 Dec;21(4):1112-1118. doi: 10.1007/s12663-020-01480-2. Epub 2020 Nov 22.
- Background: PubMed 41255399Georgakopoulou E, Loumou P, Sgouros D, Chaurasia A, Panagiotopoulos A. Cryosurgery in oral lesions. J Clin Exp Dent. 2025 Oct 1;17(10):e1257-e1266. doi: 10.4317/jced.63133. eCollection 2025 Oct.
- Background: PubMed 39054510Sobouti F, Moallem Savasari A, Aryana M, Hakimiha N, Dadgar S. Maxillary labial frenectomy: a randomized, controlled comparative study of two blue (445 nm) and infrared (980 nm) diode lasers versus surgical scalpel. BMC Oral Health. 2024 Jul 25;24(1):843. doi: 10.1186/s12903-024-04364-w.
- Individual participant dataSharing planned: No
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.
Muhammet Yasin Pektaş, Asst. Prof, DDS principal investigator
Kutahya Health Sciences University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 970-nm Diode Laser Frenectomy and Liquid Nitrogen Cryotherapy in people with Maxillary Labial Frenulum Abnormality and Hypertrophic Maxillary Labial Frenulum, run by Kutahya Health Sciences 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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 9 Oct 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammet Yasin Pektaş, Asst. Prof, DDS (+905541351195, muhammetyasin.pektas@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in salivary cortisol level from baseline to postoperative day 2 (time frame: Baseline and postoperative day 2). 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 NCT07708389, which also lists 3 linked publications.
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 9 Oct 2026.