Frenulum; HypertrophyNCT07853599
Diode Laser Versus Conventional Frenectomy in Children
A study testing Diode Laser Frenectomy and Conventional Scalpel Frenectomy in people with Frenulum; Hypertrophy and Diode Laser, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, open-label, parallel-group clinical trial aims to compare diode laser frenectomy with conventional scalpel frenectomy in children aged 8-12 years with a clinical indication for maxillary labial frenectomy. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Frenulum; Hypertrophy, Diode Laser, Frenectomy
- What is being tested?
- Diode Laser Frenectomy and Conventional Scalpel Frenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 30 Nov 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 8-12 years.
- Presence of a clinical indication for maxillary labial frenectomy.
- Systemically healthy.
- No previous frenulum surgery in the relevant region.
- Ability to attend scheduled clinical follow-up and gingival crevicular fluid sampling visits.
- Written informed consent provided by a parent or legal guardian.
- Age-appropriate assent provided by the child.
- Adequate cooperation to undergo the planned clinical procedures and gingival crevicular fluid sampling.
Who cannot join
- Presence of a systemic disease or condition that may affect wound healing or inflammatory responses.
- Active local infection or clinically significant inflammation in the relevant region.
- Use of systemic antibiotics, anti-inflammatory drugs, or corticosteroids within the previous month.
- Regular use of medications known to affect wound healing or inflammatory responses.
- Inadequate cooperation preventing completion of the surgical procedure or gingival crevicular fluid sampling.
- Absence of parental/legal guardian consent or child assent.
- Inability to complete the scheduled follow-up and sampling visits.
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
Van Yüzüncü Yıl University Faculty of Dentistry
Van
Burçin AVCI, DDS, +905359558140, burcinavci@yyu.edu.tr
About this study
Official title: Clinical Outcomes and Local Molecular Biomarker Changes in Gingival Crevicular Fluid Following Diode Laser Versus Conventional Frenectomy in Children: A Randomized Clinical Trial
This prospective, randomized, open-label, parallel-group clinical trial aims to compare diode laser frenectomy with conventional scalpel frenectomy in children aged 8-12 years with a clinical indication for maxillary labial frenectomy. Participants will be randomly allocated in a 1:1 ratio to undergo either diode laser or conventional scalpel frenectomy. Postoperative pain, wound healing, analgesic requirement, feeding difficulty, and daily comfort will be evaluated during follow-up. Gingival crevicular fluid samples will be collected at baseline and on postoperative Days 3, 7, and 14 to assess local molecular changes associated with inflammation, tissue injury, wound healing, and periodontal-alveolar remodeling using RT-qPCR.
Read the detailed description
This study is a prospective, randomized, open-label, two-arm, parallel-group clinical trial designed to compare the postoperative clinical and local molecular responses following diode laser and conventional scalpel frenectomy in children.
Children aged 8-12 years with a clinical indication for maxillary labial frenectomy who meet the eligibility criteria will be randomly allocated in a 1:1 ratio to either the diode laser frenectomy group or the conventional scalpel frenectomy group using computer-generated randomization. Because the two surgical procedures are visibly and technically different, masking of the treating clinician and participants is not feasible.
Clinical evaluations will be performed at baseline and during postoperative follow-up. Postoperative pain will be assessed using a 0-10 Visual Analog Scale (VAS), and wound healing will be evaluated using the Landry, Turnbull and Howley Wound Healing Index. Analgesic requirement, feeding difficulty, daily comfort, and other clinical healing findings will also be recorded. Standardized intraoral photographs obtained during follow-up will provide supportive assessment of postoperative wound healing.
Gingival crevicular fluid samples will be collected from the gingival sulcus adjacent to the maxillary central incisors at baseline (Day 0) and on postoperative Days 3, 7, and 14. Two sterile paper points will be used at each sampling time point. Samples will be transferred to RNase-free tubes, transported under cold-chain conditions, and stored at -80°C until molecular analysis.
RNA isolation, complementary DNA synthesis, and RT-qPCR analyses will be performed to evaluate gene expression changes related to inflammation, tissue injury, wound healing, and local periodontal-alveolar remodeling. Planned molecular targets include IL1B, TNF, IL8, FGF2, TGFB1, an LDH metabolism-related target gene, and SOST. GAPDH and ACTB will be used as reference genes. SOST will be evaluated as a secondary exploratory marker of local periodontal-alveolar remodeling.
Changes in clinical and molecular outcomes will be evaluated over time and between treatment groups, including assessment of group, time, and group-by-time effects.
- Conditions
- Frenulum; Hypertrophy, Diode Laser, Frenectomy, RT-PCR
- Being tested
- Diode Laser Frenectomy, Conventional Scalpel Frenectomy
- Keywords
- Frenectomy, Maxillary Labial Frenum, Inflammatory Biomarkers
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode Laser FrenectomyProcedure or surgery
Maxillary labial frenectomy will be performed using a Woodpecker LX16 Plus diode laser under standardized clinical conditions. The procedure will be carried out by the Department of Periodontology. Laser parameters, including wavelength, power, operating mode, fiber diameter, and application technique, will be standardized according to the final study protocol.
Conventional Scalpel FrenectomyProcedure or surgery
Maxillary labial frenectomy will be performed using a conventional surgical scalpel under standardized clinical conditions. The procedure will be carried out by the Department of Periodontology according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Diode Laser Frenectomy | Experimental | Children aged 8-12 years assigned to this arm will undergo maxillary labial frenectomy using a diode laser. Clinical evaluations and gingival crevicular fluid sampling will be performed at baseline (Day 0) and on postoperative Days 3, 7, and 14. Receives: Procedure: Diode Laser Frenectomy |
| Conventional Scalpel Frenectomy | Active comparator | Children aged 8-12 years assigned to this arm will undergo maxillary labial frenectomy using a conventional surgical scalpel. Clinical evaluations and gingival crevicular fluid sampling will be performed at baseline (Day 0) and on postoperative Days 3, 7, and 14. Receives: Procedure: Conventional Scalpel Frenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative IL1B Gene Expression in Gingival Crevicular Fluid
Relative IL1B gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
Measured: Baseline (Day 0) and postoperative Days 3, 7, and 14
Relative TNF Gene Expression in Gingival Crevicular Fluid
Relative TNF gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
Measured: Baseline (Day 0) and postoperative Days 3, 7, and 14
Relative IL8 Gene Expression in Gingival Crevicular Fluid
Relative IL8 gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
Measured: Baseline (Day 0) and postoperative Days 3, 7, and 14
Relative FGF2 Gene Expression in Gingival Crevicular Fluid
Relative FGF2 gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
Measured: Baseline (Day 0) and postoperative Days 3, 7, and 14
Relative TGFB1 Gene Expression in Gingival Crevicular Fluid
Relative TGFB1 gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
Measured: Baseline (Day 0) and postoperative Days 3, 7, and 14
Relative LDHA Gene Expression in Gingival Crevicular Fluid
Relative LDHA gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
Measured: Baseline (Day 0) and postoperative Days 3, 7, and 14
Postoperative Wound Healing Assessed Using the Landry, Turnbull and Howley Wound Healing Index
Postoperative wound healing will be evaluated using the Landry, Turnbull and Howley Wound Healing Index. Healing will be scored from 1 (very poor healing) to 5 (excellent healing). Scores will be compared between treatment groups and across postoperative follow-up time points.
Measured: Postoperative Days 3, 7, and 14
Postoperative Pain Intensity Assessed Using the Visual Analog Scale
Postoperative pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. VAS scores will be compared between treatment groups and across postoperative follow-up time points.
Measured: Postoperative Days 3, 7, and 14
Secondary outcomes (4)
Relative SOST Gene Expression in Gingival Crevicular Fluid
Relative SOST gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. SOST will be evaluated as an exploratory marker of local periodontal-alveolar remodeling following frenectomy.
Measured: Baseline (Day 0) and postoperative Days 3, 7, and 14
Postoperative Analgesic Use
Postoperative analgesic use will be recorded during follow-up. The number of analgesic doses taken by each participant will be documented and compared between the diode laser and conventional scalpel frenectomy groups.
Measured: Postoperative Days 3, 7, and 14
Postoperative Feeding Difficulty
Feeding difficulty will be assessed using a 0-10 numerical rating scale, where 0 indicates no difficulty with eating and 10 indicates the greatest possible difficulty. Scores will be compared between the diode laser and conventional scalpel frenectomy groups.
Measured: Postoperative Days 3, 7, and 14
Postoperative Daily Comfort
Daily comfort will be assessed using a 0-10 numerical rating scale, where 0 indicates extreme discomfort and 10 indicates complete comfort. Scores will be compared between the diode laser and conventional scalpel frenectomy groups.
Measured: Postoperative Days 3, 7, and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion14 Oct 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frenulum; HypertrophyStudies 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
- Model description
- Eligible participants will be randomly allocated in a 1:1 ratio to two parallel treatment groups: diode laser frenectomy or conventional scalpel frenectomy. Clinical and molecular outcomes will be evaluated at baseline and during postoperative follow-up.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burçin AVCI, Yuzuncu Yil University
- Investigators
- Burçin AVCI, Principal investigator, Van Yüzüncü Yıl Universityc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853599
- Sponsor's protocol ID
- VYYU-PEDO-FREN-2026-01
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared because the study involves pediatric participants and molecular biomarker data. De-identified aggregate results will be reported in scientific publications in accordance with applicable ethical and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes and Local Molecular Biomarker Changes in Gingival Crevicular Fluid Following Diode Laser Versus Conventional Frenectomy in Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07853599
- Acronym / sponsor ID
- VYYU-PEDO-FREN-2026-01
- Conditions
- Frenulum; Hypertrophy, Diode Laser, Frenectomy, RT-PCR
- Keywords
- Frenectomy, Maxillary Labial Frenum, Inflammatory Biomarkers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 14 Oct 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 2 Oct 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, open-label, parallel-group clinical trial aims to compare diode laser frenectomy with conventional scalpel frenectomy in children aged 8-12 years with a clinical indication for maxillary labial frenectomy. Participants will be randomly allocated in a 1:1 ratio to undergo either diode laser or conventional scalpel frenectomy. Postoperative pain, wound healing, analgesic requirement, feeding difficulty, and daily comfort will be evaluated during follow-up. Gingival crevicular fluid samples will be collected at baseline and on postoperative Days 3, 7, and 14 to assess local molecular changes associated with inflammation, tissue injury, wound healing, and periodontal-alveolar remodeling using RT-qPCR.
Detailed description
This study is a prospective, randomized, open-label, two-arm, parallel-group clinical trial designed to compare the postoperative clinical and local molecular responses following diode laser and conventional scalpel frenectomy in children.
Children aged 8-12 years with a clinical indication for maxillary labial frenectomy who meet the eligibility criteria will be randomly allocated in a 1:1 ratio to either the diode laser frenectomy group or the conventional scalpel frenectomy group using computer-generated randomization. Because the two surgical procedures are visibly and technically different, masking of the treating clinician and participants is not feasible.
Clinical evaluations will be performed at baseline and during postoperative follow-up. Postoperative pain will be assessed using a 0-10 Visual Analog Scale (VAS), and wound healing will be evaluated using the Landry, Turnbull and Howley Wound Healing Index. Analgesic requirement, feeding difficulty, daily comfort, and other clinical healing findings will also be recorded. Standardized intraoral photographs obtained during follow-up will provide supportive assessment of postoperative wound healing.
Gingival crevicular fluid samples will be collected from the gingival sulcus adjacent to the maxillary central incisors at baseline (Day 0) and on postoperative Days 3, 7, and 14. Two sterile paper points will be used at each sampling time point. Samples will be transferred to RNase-free tubes, transported under cold-chain conditions, and stored at -80°C until molecular analysis.
RNA isolation, complementary DNA synthesis, and RT-qPCR analyses will be performed to evaluate gene expression changes related to inflammation, tissue injury, wound healing, and local periodontal-alveolar remodeling. Planned molecular targets include IL1B, TNF, IL8, FGF2, TGFB1, an LDH metabolism-related target gene, and SOST. GAPDH and ACTB will be used as reference genes. SOST will be evaluated as a secondary exploratory marker of local periodontal-alveolar remodeling.
Changes in clinical and molecular outcomes will be evaluated over time and between treatment groups, including assessment of group, time, and group-by-time effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible participants will be randomly allocated in a 1:1 ratio to two parallel treatment groups: diode laser frenectomy or conventional scalpel frenectomy. Clinical and molecular outcomes will be evaluated at baseline and during postoperative follow-up.
| Arm | Type | Receives |
|---|---|---|
| Diode Laser Frenectomy | Experimental | Procedure: Diode Laser FrenectomyChildren aged 8-12 years assigned to this arm will undergo maxillary labial frenectomy using a diode laser. Clinical evaluations and gingival crevicular fluid sampling will be performed at baseline (Day 0) and on postoperative Days 3, 7, and 14. |
| Conventional Scalpel Frenectomy | Active comparator | Procedure: Conventional Scalpel FrenectomyChildren aged 8-12 years assigned to this arm will undergo maxillary labial frenectomy using a conventional surgical scalpel. Clinical evaluations and gingival crevicular fluid sampling will be performed at baseline (Day 0) and on postoperative Days 3, 7, and 14. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children aged 8-12 years.
- Presence of a clinical indication for maxillary labial frenectomy.
- Systemically healthy.
- No previous frenulum surgery in the relevant region.
- Ability to attend scheduled clinical follow-up and gingival crevicular fluid sampling visits.
Key exclusion criteria (7 listed)
- Presence of a systemic disease or condition that may affect wound healing or inflammatory responses.
- Active local infection or clinically significant inflammation in the relevant region.
- Use of systemic antibiotics, anti-inflammatory drugs, or corticosteroids within the previous month.
- Regular use of medications known to affect wound healing or inflammatory responses.
- Inadequate cooperation preventing completion of the surgical procedure or gingival crevicular fluid sampling.
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 FrenectomyMaxillary labial frenectomy will be performed using a Woodpecker LX16 Plus diode laser under standardized clinical conditions. The procedure will be carried out by the Department of Periodontology. Laser parameters, including wavelength, power, operating mode, fiber diameter, and application technique, will be standardized according to the final study protocol. | Procedure or surgery | Diode Laser Frenectomy |
| Conventional Scalpel FrenectomyMaxillary labial frenectomy will be performed using a conventional surgical scalpel under standardized clinical conditions. The procedure will be carried out by the Department of Periodontology according to the study protocol. | Procedure or surgery | Conventional Scalpel Frenectomy |
Primary outcome
Relative IL1B Gene Expression in Gingival Crevicular Fluid
Time frame: Baseline (Day 0) and postoperative Days 3, 7, and 14
Relative IL1B gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
Relative TNF Gene Expression in Gingival Crevicular Fluid
Time frame: Baseline (Day 0) and postoperative Days 3, 7, and 14
Relative TNF gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
Relative IL8 Gene Expression in Gingival Crevicular Fluid
Time frame: Baseline (Day 0) and postoperative Days 3, 7, and 14
Relative IL8 gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
Relative FGF2 Gene Expression in Gingival Crevicular Fluid
Time frame: Baseline (Day 0) and postoperative Days 3, 7, and 14
Relative FGF2 gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
Relative TGFB1 Gene Expression in Gingival Crevicular Fluid
Time frame: Baseline (Day 0) and postoperative Days 3, 7, and 14
Relative TGFB1 gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
Relative LDHA Gene Expression in Gingival Crevicular Fluid
Time frame: Baseline (Day 0) and postoperative Days 3, 7, and 14
Relative LDHA gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
Postoperative Wound Healing Assessed Using the Landry, Turnbull and Howley Wound Healing Index
Time frame: Postoperative Days 3, 7, and 14
Postoperative wound healing will be evaluated using the Landry, Turnbull and Howley Wound Healing Index. Healing will be scored from 1 (very poor healing) to 5 (excellent healing). Scores will be compared between treatment groups and across postoperative follow-up time points.
Postoperative Pain Intensity Assessed Using the Visual Analog Scale
Time frame: Postoperative Days 3, 7, and 14
Postoperative pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. VAS scores will be compared between treatment groups and across postoperative follow-up time points.
4 secondary outcomes
Relative SOST Gene Expression in Gingival Crevicular Fluid
Time frame: Baseline (Day 0) and postoperative Days 3, 7, and 14
Postoperative Analgesic Use
Time frame: Postoperative Days 3, 7, and 14
Postoperative Feeding Difficulty
Time frame: Postoperative Days 3, 7, and 14
Postoperative Daily Comfort
Time frame: Postoperative Days 3, 7, and 14
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 2 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared because the study involves pediatric participants and molecular biomarker data. De-identified aggregate results will be reported in scientific publications in accordance with applicable ethical and institutional requirements.
Related trials for Frenulum; Hypertrophy
Not yet recruiting
970-nm Diode Laser Versus Liquid Nitrogen Cryotherapy in Maxillary Labial Frenectomy
Maxillary Labial Frenulum Abnormality, Hypertrophic Maxillary Labial Frenulum
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.
Burçin AVCI principal investigator
Van Yüzüncü Yıl Universityc
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 Frenectomy and Conventional Scalpel Frenectomy in people with Frenulum; Hypertrophy and Diode Laser, run by Yuzuncu Yil 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 8 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 2 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 Burçin AVCI, DDS (+905359558140, burcinavci@yyu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative IL1B Gene Expression in Gingival Crevicular Fluid (time frame: Baseline (Day 0) and postoperative Days 3, 7, and 14). The study lists 8 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 2 Oct 2026.