COMPARATIVE EFFICACY OF SCISSORS, ELECTROCAUTERY AND DIODE LASER IN THE MANAGEMENT OF ANKYLOGLOSSIA IN PEDIATRIC PATIENTS: RANDOMIZED CLINICAL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain was scored in the preoperative and postoperative periods using the Visual Analogue Scale. The quality of healing was assessed using the Healing Index proposed by Landry et al., immediately after the procedure and subsequently on the next day, fourteenth day, and 3rd month postoperative days. Heart rate and oxygen saturation were continuously monitored during the procedure using a pulse oximeter.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy children between 6 and 18 years of age with a diagnosis of tongue tie were included in the study.
- •Assessment of tongue tie was performed using the Kotlow assessment, carried out with maximum mouth opening and the tip of the tongue touching the palatal papilla.
- •The free tongue length was measured to the nearest millimetre and graded as follows, normal range of free tongue, greater than 16 mm; Class I, mild ankyloglossia, 12 to 16 mm; Class II, moderate ankyloglossia, 8 to 11 mm; Class III, severe ankyloglossia, 3 to 7 mm; and Class IV, complete ankyloglossia, less than 3 mm.
- •The Quick Tongue Tie Assessment Tool was used for the measurement of Kotlow’s free tongue length.
- •Parents of the children who consented to participate in this study.
- •Patients will be selected from Sri Venkateswara Dental College and Hospital with complete case history and the patients based on the inclusion criteria will be recruited in this study.
排除标准
- •Children with congenital or systemic abnormalities, those presenting with functional trismus, and those who had previously undergone maxillofacial surgery were excluded from the study.
- •Children with special health care needs, oral cavity abnormalities under medical management, or those receiving medication were also excluded.
- •In addition, patients who were not in good health on the day of the surgical procedure.
结局指标
主要结局
Pain was scored in the preoperative and postoperative periods using the Visual Analogue Scale. The quality of healing was assessed using the Healing Index proposed by Landry et al., immediately after the procedure and subsequently on the next day, fourteenth day, and 3rd month postoperative days. Heart rate and oxygen saturation were continuously monitored during the procedure using a pulse oximeter.
时间窗: Baseline | Immediate postoperative | 1 day postoperative | 2 weeks postoperative | 12 weeks postoperative
次要结局
- Pain was scored in the preoperative & postoperative periods using the Visual Analogue Scale. The quality of healing was assessed using the Healing Index proposed by Landry et al., immediately after the procedure & subsequently on the next day, fourteenth day, & 3rd month postoperative days. Heart rate & oxygen saturation were continuously monitored during the procedure using a pulse oximeter.(Baseline)
研究者
Dr M S Saravanakumar
Sri Venkateswara Dental College and Hospital