FrenectomyNCT07054021
Retrospective Frenectomy Analysis: Techniques and Adjunctive Antimicrobials
An observational study of Frenectomy and Erbium YAG Laser, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The frenulum is a mucosal fold that connects the lips and cheeks to the alveolar mucosa or gingiva, with abnormal attachments-particularly papillary and papillary-penetrating types-linked to clinical issues such as gingival recession, diastema, and oral hygiene difficulties. Read more about this study
- Who is it for?
- Ages 12 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Frenectomy, Erbium YAG Laser, Antimicrobial Agent
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 15 May 2025
- Phase
- Observational
- 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 12 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Among 463 patients who applied to Gülhane Faculty of Dentistry, Department of Periodontology for frenectomy indication between January 2023 and March 2025, a total of 102 patients who were treated with the traditional method and Er:Yag laser were included in the study.
Who may be able to join
- Patients who presented to the Department of Periodontology, Gülhane Faculty of Dentistry between January 1, 2023, and March 1, 2025, and underwent maxillary labial frenectomy.
- Patients from whom a complete and signed surgical informed consent form was obtained.
- Patients with complete clinical measurements recorded at baseline, and on postoperative days 7, 14, and 28.
- Patients whose wound healing was scored using the Landry Wound Healing Index and documented on days 7, 14, and 28 postoperatively.
- Patients whose epithelialization status was evaluated and documented on postoperative days 7, 14, and 28.
- Patients who received one of the following treatment protocols:
Show all 12Show fewer
- Conventional surgery + postoperative use of Kloroben mouthwash,
- Er:YAG laser surgery + postoperative use of Kloroben mouthwash,
- Conventional surgery + postoperative use of Klorhex Plus mouthwash,
- Er:YAG laser surgery + postoperative use of Klorhex Plus mouthwash.
- Patients who completed a written pain assessment using the Visual Analog Scale (VAS) daily for one week postoperatively.
- Patients who documented postoperative bleeding and the number of analgesic intakes in written form.
Who cannot join
- Patients who presented to the Department of Periodontology, Gülhane Faculty of Dentistry between January 1, 2023, and March 1, 2025, and underwent mandibular labial frenectomy.
- Patients with incomplete or missing surgical informed consent forms.
- Patients for whom clinical measurements, Landry wound healing scores, and hydrogen peroxide (H₂O₂) tests were not performed.
- Patients treated with diode laser.
- Patients whose postoperative VAS pain records, number of analgesics used, and bleeding status were not documented.
- Patients who received postoperative antibiotic therapy.
- Patients who did not use Kloroben or Klorhex Plus mouthwash postoperatively.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University Gulhane Faculty of Dentistry
Ankara, KEÇİÖREN
About this study
Official title: "Evaluating the Impact of Diverse Antimicrobial Agents on Clinical Outcomes of Various Frenectomy Techniques: A Retrospective Study"
The frenulum is a mucosal fold that connects the lips and cheeks to the alveolar mucosa or gingiva, with abnormal attachments-particularly papillary and papillary-penetrating types-linked to clinical issues such as gingival recession, diastema, and oral hygiene difficulties. Frenectomy, the complete removal of the frenulum, can be performed using traditional scalpel techniques or soft tissue lasers like Er:YAG, which offers precise cutting with minimal thermal damage. While laser surgery reduces pain and promotes faster healing, it requires careful control and involves higher costs. Postoperative care often includes chlorhexidine-based agents due to their antimicrobial and healing-promoting properties; combinations like Klorhex Plus (chlorhexidine digluconate and flurbiprofen) have demonstrated effectiveness in reducing edema and enhancing wound healing.
Read the detailed description
The frenulum is a mucosal fold, usually containing closed muscle fibers, that connects the lips and cheeks to the alveolar mucosa and/or gingiva and underlying periosteum. The frenulum problem is most common on the labial surface between the maxillary and mandibular central incisors and in the canine and premolar areas. 1 The labial frenulum restricts and stabilizes lip movement and can also cause gingival recession. 1 Depending on the attachment extension of the fibers, the frenulum is classified as follows: Mucosal; when the frenal fibers are attached up to the mucogingival junction, Gingiva; when fibers are placed inside the attached gingiva, Papillary; when fibers extend towards the interdental papilla, Penetrating the papilla; when the frenal fibers cross the alveolar process and extend to the palatine papilla. 2 Clinically, papillary and papillary-penetrating frenulum are considered pathologic and have been associated with papilla loss, recession, diastema, difficulty in brushing, tooth alignment and psychological disturbances of the individual. 3,4 Frenectomy is the complete removal of the frenulum, including its attachment to the underlying bone. There are two techniques for frenectomy. One is the traditional technique using scalpels and periodontal blades, and the other is the technique using soft tissue lasers. 5,6 Er:YAG is highly effective in cutting soft tissues. Its wavelength is 2940 nm, allowing for shallow penetration and a high water absorption rate. This type of laser can be strongly absorbed by water molecules in the irradiated area, producing a photoelectric effect that causes the water temperature to rise sharply.
Both techniques have some disadvantages; the traditional scalpel technique results in a large rhomboidal wound area at the bottom where primary closure is not possible, and healing occurs with secondary intention. It also causes more pain and discomfort to the patient compared to the laser technique. 7 On the other hand, the laser is an expensive device, and its use requires more precision and control, causing bone necrosis if the beam contacts the bone surface.
Chlorhexidine (CHX) is a cationic bisbiguanide compound with broad-spectrum antimicrobial properties. Although the mouthwash form is most used in dentistry after surgical procedures, gel, spray and dental varnish forms are also preferred for their antiplaque and healing acceleration properties. 8 Klorhex Plus mouthwash, containing 0.5 g flurbiprofen and 0.24 g chlorhexidine digluconate has also been shown to have significant contributions in reducing edema and accelerating wound healing in oral wounds.9
- Conditions
- Frenectomy, Erbium YAG Laser, Antimicrobial Agent
- Keywords
- frenectomy, erbium yag laser, chlorhexidine, wound healing, visual analog scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Surgery + Postoperative Chlorobene use of mouthwash | Not described | |
| Er:Yag laser surgery + Postoperative use of Chlorobene mouthwash | Not described | |
| Conventional surgery + Postoperative use of Chlorhex plus mouthwash | Not described | |
| Er:Yag laser surgery + Postoperative use of Chlorhex plus mouthwash | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing (WHI) was used as the primary outcome measure.
Wound healing was scored according to WHI 14. The WHI was recorded on the 7th, 14th and 28th days. The primary outcome of the study was to measure the palatal wound healing status using the WHI, which grades the wound healing on a scale. This index, which has a score range of 1 (very poor) to 5 (excellent), evaluates tissue color, response to palpation, granulation tissue presence, incision margins' epithelialization, and amount of suppuration
Measured: The WHI was recorded on the 7th, 14th and 28th days.
Secondary outcomes (1)
Postoperative pain was evaluated as a secondary outcome.
Measured: The secondary results of the study showed that patients' perceptions of pain after surgical procedures were rated on a numerical rating scale from; VAS 0 (no pain) and 100 (the most severe pain imaginable) between days 1 and 7 and post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start15 May 2025
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrenectomyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEVAL CEYLAN ŞEN, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054021
- Sponsor's protocol ID
- Seval2
- Status last verified
- Jan 2023
- First submitted
- 27 Jun 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will not be shared as it contains personal data belonging to patients.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluating the Impact of Diverse Antimicrobial Agents on Clinical Outcomes of Various Frenectomy Techniques: A Retrospective Study"
- ClinicalTrials.gov ID
- NCT07054021
- Acronym / sponsor ID
- Seval2
- Conditions
- Frenectomy, Erbium YAG Laser, Antimicrobial Agent
- Keywords
- frenectomy, erbium yag laser, chlorhexidine, wound healing, visual analog scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 8 Jul 2025 (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 frenulum is a mucosal fold that connects the lips and cheeks to the alveolar mucosa or gingiva, with abnormal attachments-particularly papillary and papillary-penetrating types-linked to clinical issues such as gingival recession, diastema, and oral hygiene difficulties. Frenectomy, the complete removal of the frenulum, can be performed using traditional scalpel techniques or soft tissue lasers like Er:YAG, which offers precise cutting with minimal thermal damage. While laser surgery reduces pain and promotes faster healing, it requires careful control and involves higher costs. Postoperative care often includes chlorhexidine-based agents due to their antimicrobial and healing-promoting properties; combinations like Klorhex Plus (chlorhexidine digluconate and flurbiprofen) have demonstrated effectiveness in reducing edema and enhancing wound healing.
Detailed description
The frenulum is a mucosal fold, usually containing closed muscle fibers, that connects the lips and cheeks to the alveolar mucosa and/or gingiva and underlying periosteum. The frenulum problem is most common on the labial surface between the maxillary and mandibular central incisors and in the canine and premolar areas. 1 The labial frenulum restricts and stabilizes lip movement and can also cause gingival recession. 1 Depending on the attachment extension of the fibers, the frenulum is classified as follows: Mucosal; when the frenal fibers are attached up to the mucogingival junction, Gingiva; when fibers are placed inside the attached gingiva, Papillary; when fibers extend towards the interdental papilla, Penetrating the papilla; when the frenal fibers cross the alveolar process and extend to the palatine papilla. 2 Clinically, papillary and papillary-penetrating frenulum are considered pathologic and have been associated with papilla loss, recession, diastema, difficulty in brushing, tooth alignment and psychological disturbances of the individual. 3,4 Frenectomy is the complete removal of the frenulum, including its attachment to the underlying bone. There are two techniques for frenectomy. One is the traditional technique using scalpels and periodontal blades, and the other is the technique using soft tissue lasers. 5,6 Er:YAG is highly effective in cutting soft tissues. Its wavelength is 2940 nm, allowing for shallow penetration and a high water absorption rate. This type of laser can be strongly absorbed by water molecules in the irradiated area, producing a photoelectric effect that causes the water temperature to rise sharply.
Both techniques have some disadvantages; the traditional scalpel technique results in a large rhomboidal wound area at the bottom where primary closure is not possible, and healing occurs with secondary intention. It also causes more pain and discomfort to the patient compared to the laser technique. 7 On the other hand, the laser is an expensive device, and its use requires more precision and control, causing bone necrosis if the beam contacts the bone surface.
Chlorhexidine (CHX) is a cationic bisbiguanide compound with broad-spectrum antimicrobial properties. Although the mouthwash form is most used in dentistry after surgical procedures, gel, spray and dental varnish forms are also preferred for their antiplaque and healing acceleration properties. 8 Klorhex Plus mouthwash, containing 0.5 g flurbiprofen and 0.24 g chlorhexidine digluconate has also been shown to have significant contributions in reducing edema and accelerating wound healing in oral wounds.9
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Conventional Surgery + Postoperative Chlorobene use of mouthwash | – | – |
| Er:Yag laser surgery + Postoperative use of Chlorobene mouthwash | – | – |
| Conventional surgery + Postoperative use of Chlorhex plus mouthwash | – | – |
| Er:Yag laser surgery + Postoperative use of Chlorhex plus mouthwash | – | – |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Among 463 patients who applied to Gülhane Faculty of Dentistry, Department of Periodontology for frenectomy indication between January 2023 and March 2025, a total of 102 patients who were treated with the traditional method and Er:Yag laser were included in the study.
Key inclusion criteria (12 listed)
- Patients who presented to the Department of Periodontology, Gülhane Faculty of Dentistry between January 1, 2023, and March 1, 2025, and underwent maxillary labial frenectomy.
- Patients from whom a complete and signed surgical informed consent form was obtained.
- Patients with complete clinical measurements recorded at baseline, and on postoperative days 7, 14, and 28.
- Patients whose wound healing was scored using the Landry Wound Healing Index and documented on days 7, 14, and 28 postoperatively.
- Patients whose epithelialization status was evaluated and documented on postoperative days 7, 14, and 28.
Key exclusion criteria (7 listed)
- Patients who presented to the Department of Periodontology, Gülhane Faculty of Dentistry between January 1, 2023, and March 1, 2025, and underwent mandibular labial frenectomy.
- Patients with incomplete or missing surgical informed consent forms.
- Patients for whom clinical measurements, Landry wound healing scores, and hydrogen peroxide (H₂O₂) tests were not performed.
- Patients treated with diode laser.
- Patients whose postoperative VAS pain records, number of analgesics used, and bleeding status were not documented.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Wound healing (WHI) was used as the primary outcome measure.
Time frame: The WHI was recorded on the 7th, 14th and 28th days.
Wound healing was scored according to WHI 14. The WHI was recorded on the 7th, 14th and 28th days. The primary outcome of the study was to measure the palatal wound healing status using the WHI, which grades the wound healing on a scale. This index, which has a score range of 1 (very poor) to 5 (excellent), evaluates tissue color, response to palpation, granulation tissue presence, incision margins' epithelialization, and amount of suppuration
1 secondary outcome
Postoperative pain was evaluated as a secondary outcome.
Time frame: The secondary results of the study showed that patients' perceptions of pain after surgical procedures were rated on a numerical rating scale from; VAS 0 (no pain) and 100 (the most severe pain imaginable) between days 1 and 7 and post-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 14 Jul 2025.
- Individual participant dataSharing planned: No. It will not be shared as it contains personal data belonging to patients.
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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?
An observational study of Frenectomy and Erbium YAG Laser, run by Saglik Bilimleri Universitesi 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 12 inclusion and 7 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 14 Jul 2025. 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?
Wound healing (WHI) was used as the primary outcome measure. (time frame: The WHI was recorded on the 7th, 14th and 28th days.). 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 14 Jul 2025; AzTrials last refreshed its copy on 1 Nov 2026.