Frenulum; Hypertrophy, LipNCT07465536
Comparison of Diode Laser and Scalpel Frenectomy With or Without Photobiomodulation
A study testing Scalpel Frenectomy, Diode Laser Frenectomy and Photobiomodulation Therapy in people with Frenulum; Hypertrophy, Lip, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled clinical trial aimed to compare postoperative outcames of conventional scalpel frenectomy and diode laser frenectomy with or without adjunctive photobiomodulation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frenulum; Hypertrophy, Lip
- What is being tested?
- Scalpel Frenectomy, Diode Laser Frenectomy and Photobiomodulation Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2015to 6 May 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Presence of clinically diagnosed aberrant maxillary labial frenal attachment requiring surgical frenectomy
- Non-smoker status
- Absence of systemic disease or ongoing pharmacological therapy
- Absence of active oral infection
- Ability to provide written informed consent
Who cannot join
- Pregnancy or lactation
- History of radiation therapy to the head and neck region
- Previous frenectomy surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University Faculty of Dentistry
Köseköy, Kocaeli, 41190
About this study
Official title: Comparative Evaluation of Diode Laser and Scalpel Frenectomy With or Without Adjunctive Photobiomodulation: A Randomized Controlled Clinical Trial
This randomized controlled clinical trial aimed to compare postoperative outcames of conventional scalpel frenectomy and diode laser frenectomy with or without adjunctive photobiomodulation therapy. Postoperative pain, speech difficulty, chewing difficulty, analgesic consumption, and oral health-related quality of life (OHIP-14) were evaluated.
Read the detailed description
This randomized controlled clinical trial was conducted to evaluate the clinical effectiveness and patient-centered outcomes of conventional scalpel frenectomy and diode laser frenectomy with or without adjunctive photobiomodulation therapy (PBMT). Patients presenting with an aberrant maxillary labial frenulum requiring surgical intervention were recruited and randomly allocated into study groups.
Frenectomy procedures were performed either using the conventional scalpel technique or an 810-nm diode laser system. In selected groups, adjunctive photobiomodulation therapy was applied following the surgical procedure. Postoperative outcomes were assessed using patient-reported outcome measures, including visual analogue scale (VAS) pain scores, speech difficulty, chewing difficulty, analgesic consumption, and oral health-related quality of life measured by the OHIP-14 questionnaire.
Clinical and patient-reported outcomes were evaluated during the postoperative follow-up period to compare the effects of surgical technique and adjunctive photobiomodulation therapy on postoperative discomfort, functional recovery, and quality of life.
- Conditions
- Frenulum; Hypertrophy, Lip
- Being tested
- Scalpel Frenectomy, Diode Laser Frenectomy, Photobiomodulation Therapy
- Medical subject headings
- Hypertrophy, Lymphoid Interstitial Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalpel FrenectomyProcedure or surgery
Conventional frenectomy performed using a surgical scalpel for the treatment of aberrant maxillary labial frenulum.
Diode Laser FrenectomyProcedure or surgery
Frenectomy performed using an 810-nm diode laser for the treatment of aberrant maxillary labial frenulum.
Photobiomodulation TherapyDevice
Low-level laser therapy applied postoperatively to enhance wound healing and reduce postoperative pain and discomfort.
| Study group | Role | What they receive |
|---|---|---|
| Scalpel Frenectomy | Experimental | Participants underwent conventional scalpel frenectomy for the treatment of aberrant maxillary labial frenulum. Receives: Procedure: Scalpel Frenectomy |
| Scalpel Frenectomy + Photobiomodulation Therapy | Experimental | Participants underwent conventional scalpel frenectomy followed by adjunctive photobiomodulation therapy to enhance postoperative healing and reduce discomfort. Receives: Procedure: Scalpel Frenectomy; Device: Photobiomodulation Therapy |
| Diode Laser Frenectomy | Experimental | Participants underwent frenectomy using an 810-nm diode laser for the treatment of aberrant maxillary labial frenulum. Receives: Procedure: Diode Laser Frenectomy |
| Diode Laser Frenectomy + Photobiomodulation Therapy | Experimental | Participants underwent frenectomy using an 810-nm diode laser followed by adjunctive photobiomodulation therapy to enhance postoperative healing and reduce discomfort. Receives: Procedure: Diode Laser Frenectomy; Device: Photobiomodulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Postoperative pain intensity assessed using a Visual Analog Scale (VAS) following frenectomy procedures.
Measured: Day 1 and Day 7 after surgery
Speech Difficulty
Speech difficulty assessed using a Visual Analog Scale (VAS) following frenectomy procedures.
Measured: Day 1 and Day 7 after surgery
Chewing Difficulty
Chewing difficulty assessed using a Visual Analog Scale (VAS) following frenectomy procedures.
Measured: Day 1 and Day 7 after surgery
Total Analgesic Consumption
Total number of analgesic tablets consumed during the postoperative period.
Measured: Within 7 days after surgery
Secondary outcomes (5)
Plaque Index (PI)
Plaque accumulation assessed using the Silness and Löe Plaque Index at the maxillary central incisors.
Measured: Baseline and 2 months after surgery
Gingival Index (GI)
Gingival inflammation assessed using the Löe and Silness Gingival Index at the maxillary central incisors.
Measured: Baseline and 2 months after surgery
Probing Depth (PD)
Periodontal probing depth measured at the mesial, distal, buccal and palatal aspects of the maxillary central incisors using a calibrated periodontal probe.
Measured: Baseline and 2 months after surgery
Keratinized Tissue Width (KTW)
Width of keratinized gingiva measured clinically using Lugol's iodine staining and a calibrated periodontal probe.
Measured: Baseline and 2 months after surgery
OHIP-14
Oral health-related quality of life assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire.
Measured: Baseline, Day 1 and Day 7 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start2 Dec 2015
- Primary completion16 Mar 2016
- Study completion6 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frenulum; Hypertrophy, LipStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Yaprak, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465536
- Sponsor's protocol ID
- 2015/37
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Diode Laser and Scalpel Frenectomy With or Without Adjunctive Photobiomodulation: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07465536
- Acronym / sponsor ID
- 2015/37
- Conditions
- Frenulum; Hypertrophy, Lip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 2 Dec 2015 (actual)
- Primary completion
- 16 Mar 2016 (actual)
- Study completion
- 6 May 2016 (actual)
- First posted
- 12 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.
This randomized controlled clinical trial aimed to compare postoperative outcames of conventional scalpel frenectomy and diode laser frenectomy with or without adjunctive photobiomodulation therapy. Postoperative pain, speech difficulty, chewing difficulty, analgesic consumption, and oral health-related quality of life (OHIP-14) were evaluated.
Detailed description
This randomized controlled clinical trial was conducted to evaluate the clinical effectiveness and patient-centered outcomes of conventional scalpel frenectomy and diode laser frenectomy with or without adjunctive photobiomodulation therapy (PBMT). Patients presenting with an aberrant maxillary labial frenulum requiring surgical intervention were recruited and randomly allocated into study groups.
Frenectomy procedures were performed either using the conventional scalpel technique or an 810-nm diode laser system. In selected groups, adjunctive photobiomodulation therapy was applied following the surgical procedure. Postoperative outcomes were assessed using patient-reported outcome measures, including visual analogue scale (VAS) pain scores, speech difficulty, chewing difficulty, analgesic consumption, and oral health-related quality of life measured by the OHIP-14 questionnaire.
Clinical and patient-reported outcomes were evaluated during the postoperative follow-up period to compare the effects of surgical technique and adjunctive photobiomodulation therapy on postoperative discomfort, functional recovery, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Scalpel Frenectomy | Experimental | Procedure: Scalpel FrenectomyParticipants underwent conventional scalpel frenectomy for the treatment of aberrant maxillary labial frenulum. |
| Scalpel Frenectomy + Photobiomodulation Therapy | Experimental | Procedure: Scalpel Frenectomy, Device: Photobiomodulation TherapyParticipants underwent conventional scalpel frenectomy followed by adjunctive photobiomodulation therapy to enhance postoperative healing and reduce discomfort. |
| Diode Laser Frenectomy | Experimental | Procedure: Diode Laser FrenectomyParticipants underwent frenectomy using an 810-nm diode laser for the treatment of aberrant maxillary labial frenulum. |
| Diode Laser Frenectomy + Photobiomodulation Therapy | Experimental | Procedure: Diode Laser Frenectomy, Device: Photobiomodulation TherapyParticipants underwent frenectomy using an 810-nm diode laser followed by adjunctive photobiomodulation therapy to enhance postoperative healing and reduce discomfort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Presence of clinically diagnosed aberrant maxillary labial frenal attachment requiring surgical frenectomy
- Non-smoker status
- Absence of systemic disease or ongoing pharmacological therapy
- Absence of active oral infection
Key exclusion criteria (3 listed)
- Pregnancy or lactation
- History of radiation therapy to the head and neck region
- Previous frenectomy surgery
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 |
|---|---|---|
| Scalpel FrenectomyConventional frenectomy performed using a surgical scalpel for the treatment of aberrant maxillary labial frenulum. | Procedure or surgery | Scalpel Frenectomy, Scalpel Frenectomy + Photobiomodulation Therapy |
| Diode Laser FrenectomyFrenectomy performed using an 810-nm diode laser for the treatment of aberrant maxillary labial frenulum. | Procedure or surgery | Diode Laser Frenectomy, Diode Laser Frenectomy + Photobiomodulation Therapy |
| Photobiomodulation TherapyLow-level laser therapy applied postoperatively to enhance wound healing and reduce postoperative pain and discomfort. | Device | Diode Laser Frenectomy + Photobiomodulation Therapy, Scalpel Frenectomy + Photobiomodulation Therapy |
Primary outcome
Postoperative Pain
Time frame: Day 1 and Day 7 after surgery
Postoperative pain intensity assessed using a Visual Analog Scale (VAS) following frenectomy procedures.
Speech Difficulty
Time frame: Day 1 and Day 7 after surgery
Speech difficulty assessed using a Visual Analog Scale (VAS) following frenectomy procedures.
Chewing Difficulty
Time frame: Day 1 and Day 7 after surgery
Chewing difficulty assessed using a Visual Analog Scale (VAS) following frenectomy procedures.
Total Analgesic Consumption
Time frame: Within 7 days after surgery
Total number of analgesic tablets consumed during the postoperative period.
5 secondary outcomes
Plaque Index (PI)
Time frame: Baseline and 2 months after surgery
Gingival Index (GI)
Time frame: Baseline and 2 months after surgery
Probing Depth (PD)
Time frame: Baseline and 2 months after surgery
Keratinized Tissue Width (KTW)
Time frame: Baseline and 2 months after surgery
OHIP-14
Time frame: Baseline, Day 1 and Day 7 after surgery
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 12 Mar 2026.
- 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.
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 Scalpel Frenectomy, Diode Laser Frenectomy and Photobiomodulation Therapy in people with Frenulum; Hypertrophy, Lip, run by Kocaeli 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 6 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 12 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 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?
Postoperative Pain (time frame: Day 1 and Day 7 after surgery). The study lists 4 primary outcomes in all. 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 12 Mar 2026.