Diode Laser Versus Conventional Frenectomy in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-12
SponsorYuzuncu Yil University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 8-12 years.
Presence of a clinical indication for maxillary labial frenectomy.
Systemically healthy.
No previous frenulum surgery in the relevant region.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Diode Laser Frenectomy
Procedure/SurgeryMaxillary 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 Frenectomy
Procedure/SurgeryMaxillary 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Diode Laser FrenectomyExperimental treatment 1 intervention
Group B: Conventional Scalpel FrenectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (Day 0) and postoperative Days 3, 7, and 142
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.
Time frame
Baseline (Day 0) and postoperative Days 3, 7, and 143
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.
Time frame
Baseline (Day 0) and postoperative Days 3, 7, and 144
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.
Time frame
Baseline (Day 0) and postoperative Days 3, 7, and 14Secondary outcomes
1
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.
Time frame
Baseline (Day 0) and postoperative Days 3, 7, and 142
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.
Time frame
Postoperative Days 3, 7, and 143
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.
Time frame
Postoperative Days 3, 7, and 144
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.
Time frame
Postoperative Days 3, 7, and 14Sponsors and contacts
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Source ClinicalTrials.gov
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