Abnormal Labial Frenum FrenectomyPED-FRENNCT07706023
Pain After Diode Laser Frenectomy in Children
A study testing Diode Laser-Assisted Frenectomy in people with Abnormal Labial Frenum Frenectomy and Frenectomy, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This prospective single-group clinical study aims to evaluate postoperative pain following diode laser-assisted frenectomy in pediatric patients and to assess the agreement between different pediatric pain assessment scales. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Abnormal Labial Frenum Frenectomy, Frenectomy
- What is being tested?
- Diode Laser-Assisted Frenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2026to 31 Dec 2026
- 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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 8 to 14 years.
- Patients requiring diode laser-assisted frenectomy based on clinical indication.
- American Society of Anesthesiologists (ASA) Physical Status I or II.
- Ability of the participant and parent/legal guardian to understand the study procedures.
- Written informed consent obtained from the parent or legal guardian, with assent obtained from the child when appropriate.
Who cannot join
- Presence of systemic diseases or medical conditions that could influence wound healing or pain perception.
- Current use of analgesic, anti-inflammatory, corticosteroid, or psychotropic medications.
- History of allergy or contraindication to local anesthetic agents.
- Acute oral infection at the surgical site.
- Previous oral soft tissue surgery in the same anatomical region.
- Inability or unwillingness to complete the postoperative pain assessment forms for seven consecutive days.
- Withdrawal of consent at any time during 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
Afyonkarahisar Health Science University
Afyonkarahisar, 03300
Murat Yeşil, Assoc. Prof. Dr., 905054423142, drmurat17@hotmail.com
About this study
Official title: Postoperative Pain Assessment Following Diode Laser-Assisted Frenectomy in Pediatric Patients: A Prospective Single-Group Clinical Study
This prospective single-group clinical study aims to evaluate postoperative pain following diode laser-assisted frenectomy in pediatric patients and to assess the agreement between different pediatric pain assessment scales. Children aged 8 to 14 years who require diode laser-assisted frenectomy will be treated according to the standard clinical protocol at the Pediatric Dentistry Clinic of Afyonkarahisar Health Sciences University. Postoperative pain will be evaluated once daily for seven consecutive days using the Wong-Baker FACES Pain Rating Scale, the Modified Emoji Pain Scale (MEPS), and gender-specific pain assessment scales. The primary objective is to characterize the time course of postoperative pain during the first postoperative week. Secondary objectives include evaluating the agreement and correlation between the different pain assessment instruments used in pediatric patients. The findings are expected to contribute to the identification of reliable pain assessment methods and to improve postoperative pain evaluation following diode laser-assisted frenectomy in children.
Read the detailed description
Diode laser-assisted frenectomy has become an increasingly preferred technique in pediatric dentistry because it provides effective soft tissue management with reduced intraoperative bleeding, minimal tissue trauma, and improved postoperative comfort. Although postoperative pain is an important determinant of treatment acceptance and patient satisfaction in children, limited evidence is available regarding the temporal pattern of pain following diode laser-assisted frenectomy and the agreement between different pediatric pain assessment instruments.
This prospective single-group clinical study was conducted at the Pediatric Dentistry Clinic of Afyonkarahisar Health Sciences University. Pediatric patients aged 8 to 14 years requiring diode laser-assisted frenectomy were consecutively enrolled after obtaining written informed consent from their parents or legal guardians. All surgical procedures were performed by the same clinician using a diode laser according to the standard clinical protocol. No comparison group was included.
The primary objective of the study is to evaluate postoperative pain during the first seven postoperative days. Pain intensity is assessed once daily using the Wong-Baker FACES Pain Rating Scale, the Modified Emoji Pain Scale (MEPS), and gender-specific pediatric pain scales. The study also aims to determine the level of agreement and correlation between these pain assessment instruments and to characterize postoperative pain trajectories throughout the first postoperative week.
The findings are expected to improve the understanding of postoperative pain following diode laser-assisted frenectomy in children and to provide evidence regarding the clinical applicability and consistency of different pediatric pain assessment tools. The results may contribute to the selection of appropriate pain assessment methods in pediatric dental practice and support postoperative pain monitoring in children undergoing soft tissue laser surgery.
- Conditions
- Abnormal Labial Frenum Frenectomy, Frenectomy
- Being tested
- Diode Laser-Assisted Frenectomy
- Keywords
- Diode Laser, Laser Frenectomy, Pediatric Dentistry, Postoperative Pain, Pain Assessment, Wong-Baker FACES Pain Rating Scale, Modified Emoji Pain Scale, Children, Oral Surgery, Frenulum Abnormalities
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode Laser-Assisted FrenectomyProcedure or surgery
Diode laser-assisted frenectomy was performed under local anesthesia using a standardized surgical protocol by the same experienced pediatric dentist. Following the procedure, participants received routine postoperative care and were instructed to record postoperative pain once daily for seven consecutive days using the Wong-Baker FACES Pain Rating Scale, the Modified Emoji Pain Scale (MEPS), and gender-specific pain assessment scales.
| Study group | Role | What they receive |
|---|---|---|
| Diode Laser-Assisted Frenectomy | Experimental | Pediatric patients underwent diode laser-assisted frenectomy according to the standard clinical protocol. Postoperative pain was assessed once daily for seven consecutive days using validated pediatric pain assessment scales. Receives: Procedure: Diode Laser-Assisted Frenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity Measured by the Wong-Baker FACES Pain Rating Scale
Postoperative pain intensity assessed using the Wong-Baker FACES Pain Rating Scale.
Measured: Daily for 7 consecutive postoperative days
Postoperative Pain Intensity Measured by the Wong-Baker FACES Pain Rating Scale
Postoperative pain intensity was assessed using the Wong-Baker FACES Pain Rating Scale. Participants recorded their pain level once daily during the first seven postoperative days.
Measured: Daily for 7 days after diode laser-assisted frenectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start10 Jul 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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 Abnormal Labial Frenum 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants received the same intervention (diode laser-assisted frenectomy). There was no comparison or control group. Postoperative pain was assessed once daily for seven consecutive days using multiple validated pediatric pain assessment scales.
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgür Doğan, Afyonkarahisar Health Sciences University
- Investigators
- Özgür Doğan, Assoc. Prof. Dr., Study director, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706023
- Sponsor's protocol ID
- 25.DUS.005.DENIZ
- Other IDs
- 25.DUS.005
- Acronym
- PED-FREN
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Armfield JM. Towards a better understanding of dental anxiety and fear: Cognitions vs. experiences. Eur J Oral Sci. 2010;118(3):259-264. Klingberg G, Broberg AG. Dental fear/anxiety and dental behaviour management problems in children and adolescents. Int J Paediatr Dent. 2007;17(6):391-406. Locker D, Liddell A, Shapiro D. Diagnostic categories of dental anxiety: A population-based study. Behav Res Ther. 1999;37(3):301-307. Remi RV, Anantharaj A, Praveen P, et al. Advances in pediatric dentistry: New approaches to pain control and anxiety reduction in children. J Dent Anesth Pain Med. 2023;23(6):303-315. Eymirli PS, Turgut MD. Laser application in pediatric dentistry: A literature update. Ankara Med J. 2019.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Assessment Following Diode Laser-Assisted Frenectomy in Pediatric Patients: A Prospective Single-Group Clinical Study
- ClinicalTrials.gov ID
- NCT07706023
- Acronym / sponsor ID
- PED-FREN / 25.DUS.005.DENIZ
- Conditions
- Abnormal Labial Frenum Frenectomy, Frenectomy
- Keywords
- Diode Laser, Laser Frenectomy, Pediatric Dentistry, Postoperative Pain, Pain Assessment, Wong-Baker FACES Pain Rating Scale, Modified Emoji Pain Scale, Children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 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 single-group clinical study aims to evaluate postoperative pain following diode laser-assisted frenectomy in pediatric patients and to assess the agreement between different pediatric pain assessment scales. Children aged 8 to 14 years who require diode laser-assisted frenectomy will be treated according to the standard clinical protocol at the Pediatric Dentistry Clinic of Afyonkarahisar Health Sciences University. Postoperative pain will be evaluated once daily for seven consecutive days using the Wong-Baker FACES Pain Rating Scale, the Modified Emoji Pain Scale (MEPS), and gender-specific pain assessment scales. The primary objective is to characterize the time course of postoperative pain during the first postoperative week. Secondary objectives include evaluating the agreement and correlation between the different pain assessment instruments used in pediatric patients. The findings are expected to contribute to the identification of reliable pain assessment methods and to improve postoperative pain evaluation following diode laser-assisted frenectomy in children.
Detailed description
Diode laser-assisted frenectomy has become an increasingly preferred technique in pediatric dentistry because it provides effective soft tissue management with reduced intraoperative bleeding, minimal tissue trauma, and improved postoperative comfort. Although postoperative pain is an important determinant of treatment acceptance and patient satisfaction in children, limited evidence is available regarding the temporal pattern of pain following diode laser-assisted frenectomy and the agreement between different pediatric pain assessment instruments.
This prospective single-group clinical study was conducted at the Pediatric Dentistry Clinic of Afyonkarahisar Health Sciences University. Pediatric patients aged 8 to 14 years requiring diode laser-assisted frenectomy were consecutively enrolled after obtaining written informed consent from their parents or legal guardians. All surgical procedures were performed by the same clinician using a diode laser according to the standard clinical protocol. No comparison group was included.
The primary objective of the study is to evaluate postoperative pain during the first seven postoperative days. Pain intensity is assessed once daily using the Wong-Baker FACES Pain Rating Scale, the Modified Emoji Pain Scale (MEPS), and gender-specific pediatric pain scales. The study also aims to determine the level of agreement and correlation between these pain assessment instruments and to characterize postoperative pain trajectories throughout the first postoperative week.
The findings are expected to improve the understanding of postoperative pain following diode laser-assisted frenectomy in children and to provide evidence regarding the clinical applicability and consistency of different pediatric pain assessment tools. The results may contribute to the selection of appropriate pain assessment methods in pediatric dental practice and support postoperative pain monitoring in children undergoing soft tissue laser surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants received the same intervention (diode laser-assisted frenectomy). There was no comparison or control group. Postoperative pain was assessed once daily for seven consecutive days using multiple validated pediatric pain assessment scales.
| Arm | Type | Receives |
|---|---|---|
| Diode Laser-Assisted Frenectomy | Experimental | Procedure: Diode Laser-Assisted FrenectomyPediatric patients underwent diode laser-assisted frenectomy according to the standard clinical protocol. Postoperative pain was assessed once daily for seven consecutive days using validated pediatric pain assessment scales. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 8 to 14 years.
- Patients requiring diode laser-assisted frenectomy based on clinical indication.
- American Society of Anesthesiologists (ASA) Physical Status I or II.
- Ability of the participant and parent/legal guardian to understand the study procedures.
- Written informed consent obtained from the parent or legal guardian, with assent obtained from the child when appropriate.
Key exclusion criteria (7 listed)
- Presence of systemic diseases or medical conditions that could influence wound healing or pain perception.
- Current use of analgesic, anti-inflammatory, corticosteroid, or psychotropic medications.
- History of allergy or contraindication to local anesthetic agents.
- Acute oral infection at the surgical site.
- Previous oral soft tissue surgery in the same anatomical region.
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 Laser-Assisted FrenectomyDiode laser-assisted frenectomy was performed under local anesthesia using a standardized surgical protocol by the same experienced pediatric dentist. Following the procedure, participants received routine postoperative care and were instructed to record postoperative pain once daily for seven consecutive days using the Wong-Baker FACES Pain Rating Scale, the Modified Emoji Pain Scale (MEPS), and gender-specific pain assessment scales. | Procedure or surgery | Diode Laser-Assisted Frenectomy |
Primary outcome
Postoperative Pain Intensity Measured by the Wong-Baker FACES Pain Rating Scale
Time frame: Daily for 7 consecutive postoperative days
Postoperative pain intensity assessed using the Wong-Baker FACES Pain Rating Scale.
Postoperative Pain Intensity Measured by the Wong-Baker FACES Pain Rating Scale
Time frame: Daily for 7 days after diode laser-assisted frenectomy
Postoperative pain intensity was assessed using the Wong-Baker FACES Pain Rating Scale. Participants recorded their pain level once daily during the first seven postoperative days.
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 15 Jul 2026.
- Results publicationArmfield JM. Towards a better understanding of dental anxiety and fear: Cognitions vs. experiences. Eur J Oral Sci. 2010;118(3):259-264. Klingberg G, Broberg AG. Dental fear/anxiety and dental behaviour management problems in children and adolescents. Int J Paediatr Dent. 2007;17(6):391-406. Locker D, Liddell A, Shapiro D. Diagnostic categories of dental anxiety: A population-based study. Behav Res Ther. 1999;37(3):301-307. Remi RV, Anantharaj A, Praveen P, et al. Advances in pediatric dentistry: New approaches to pain control and anxiety reduction in children. J Dent Anesth Pain Med. 2023;23(6):303-315. Eymirli PS, Turgut MD. Laser application in pediatric dentistry: A literature update. Ankara Med J. 2019.
- 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.
Özgür Doğan, Assoc. Prof. Dr. study director
Afyonkarahisar Health Sciences 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-Assisted Frenectomy in people with Abnormal Labial Frenum Frenectomy and Frenectomy, run by Afyonkarahisar 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 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: opening soon, as of the sponsor's last update on 15 Jul 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 Özgür Doğan, Assoc. Prof. Dr. (905052777520, ozgurdogan1984@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity Measured by the Wong-Baker FACES Pain Rating Scale (time frame: Daily for 7 consecutive postoperative days). 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 NCT07706023, 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 15 Jul 2026.