1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response - Informed Consent Form
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [mssaravanapedo@gmail.com].
   


6. For how long will this data be available start date provided 19-10-2027 and end date provided 19-10-2028?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

This randomized clinical trial aims to evaluate and compare the clinical efficiency of three surgical methods surgical scissor, electrocautery, and diode laser for the release of a restricted lingual frenulum in children. The study will include healthy children between 6 and 18 years of age diagnosed with tongue-tie, assessed using the Kotlow assessment with maximum mouth opening and the tip of the tongue touching the palatal papilla, measured to the nearest millimetre and graded accordingly. The Quick Tongue Tie Assessment Tool will be used for measuring Kotlow’s free tongue length. Children will be included only if their parents provide informed consent. Exclusion criteria include children with congenital or systemic abnormalities, functional trismus, a history of maxillofacial surgery, special health care needs, oral cavity abnormalities under medical treatment, or those unwell on the day of the surgical procedure.

Patients will be recruited from Sri Venkateswara Dental College and Hospital, based on complete case history and inclusion criteria. Subjects will be randomly divided into three groups (n=30) through a computer-generated randomization sequence prepared by a statistician not involved in the study. A non-blinded researcher will perform the treatments, while a blinded researcher will conduct the post-surgical evaluations. Patients will not be blinded and will be informed of the instrument used.

Group I will include 10 patients undergoing lingual frenectomy using a surgical scissor under local anesthesia (2% lignocaine), followed by closure with interrupted 3-0 Mersilk sutures, which will be removed after one week. Group II will include 10 patients treated with electrocautery-assisted lingual frenectomy using a fine nickel-chromium tip heated up to 1200°C, with no sutures required. Group III will include 10 patients undergoing diode laser-assisted lingual frenectomy, where a diode laser (810 nm wavelength) with an initiated tip of 400 µm at 1 W continuous mode in contact mode will be used after infiltration of local anesthesia to excise the frenulum, and the outcome will be confirmed by evaluating tongue protrusion movements.

The parameters assessed will include pain during preoperative and postoperative periods using the Visual Analogue Scale, healing quality using the Healing Index by Landry et al. immediately after the procedure and on the next day, fourteenth day and 3rd month postoperative days, and continuous monitoring of heart rate and oxygen saturation with a pulse oximeter during the procedure.