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临床试验/CTRI/2026/01/100637
CTRI/2026/01/100637尚未招募不适用

Determinants of sleep-disordered breathing in tongue-tied children:a cross-sectional study

Dr M S Saravanakumar1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2026年3月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
54
试验地点
1
主要终点
Tongue mobility was measured using TRMR with tongue tip movements and assessed with the Quick Tongue Tie Tool. Intercanine, intermolar distances and molar relationship were measured using an intraoral scanner. Nasal breathing was tested with lips sealed with micropore tape for up to 180 seconds. Mallampati score was assessed clinically. Sleep was evaluated using the Children Sleep Habits Questionnaire.

研究概览

简要总结

Children with age group between 6 to 18 years will be screened for inclusion and exclusion criteria. Participants will be recruited in study on rendering informed consent. This study will be conducted in the department of Pediatric and Preventive Dentistry of Sri Venkateswara dental college & hospital and Schools in Chennai. Assessment of tongue-tie by Kotlow assessment is by using quick tongue tie assessment tool. Measurements of the free tongue is carried out with maximum mouth opening and tip of the tongue touching the palatal papilla with results expressed in and read to the nearest millimeter and graded accordingly.

Clinical assessment tool measurements assessing functional and intraoral soft tissue determinants are recorded during a routine dental examination.

Depending on the selection criteria as mentioned above the children will be categorized into two groups:

Group 1: Tongue tied (test)

Group 2: Non tongue tied (control)

The study involved six main components in control and test group:

(i) Functional measurement of tongue mobility,

(ii) Inter canine measurement of the maxillary arches using intraoral scanner and

(iii) Intermolar measurement of the maxillary arches using intraoral scanner,

(iv) Assessment of nasal breathing,

(v) Mallampati score

(vi) Angle molar classification

Measurements of tongue mobility using TRMR [Tongue Range of Motion Ratio] are performed with TIP [tongue tip extended towards the incisive papilla] and LPS [lingual-palatal suction] functional movements. Assessment of tongue mobility is by using quick tongue tie assessment tool. Intercanine distance is assessed by intraoral scanner by measuring the distance between Maxillary Canine tips.Intermolar distance is also assessed by intraoral scanner by measuring the distance between Maxillary first molar mesiobuccal cusp tips.For Nasal breathing test assessment, Lips and mouth of the subject were sealed completely with gentle MicroPore paper tape. A timer was used to assess how long the subject could comfortably breathe through the nose for up to 180 seconds with the lips and mouth taped. Subjects were deemed to pass the test if they could successfully breathe through the nose for three minutes.For Mallampati score assessment, the patient is seated in the upright position and opens their mouth while maximally protruding their tongue.Intraoral scanner is used for assessing the molar relationship (Anteroposterior arch relationship) on the basis of Angle’s definition.Children sleep habit questionnaire is used to assess sleep of the chidren.

研究设计

研究类型
Observational

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, 12–16 mm; Class II, moderate ankyloglossia, 8–11 mm; Class III, severe ankyloglossia, 3–7 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.
  • This study will be conducted in the department of Pediatric and Preventive Dentistry of Sri Venkateswara dental college & hospital and Schools in Chennai.Kotlow tongue tie class II, class III and class IV are included in tongue tie group.
  • Children with normal range of free tongue of more than 16mm are included in control group.

排除标准

  • Children with history of frenectomy, Children undergoing orthodontic treatment, maxillary expansion, Children underwent maxillofacial surgery, Missing or ectopic eruption of canines or first molars,Functional trismus,Syndromic / maxillofacial deformity / developmental anomalies.
  • and Children with special health care needs.

结局指标

主要结局

Tongue mobility was measured using TRMR with tongue tip movements and assessed with the Quick Tongue Tie Tool. Intercanine, intermolar distances and molar relationship were measured using an intraoral scanner. Nasal breathing was tested with lips sealed with micropore tape for up to 180 seconds. Mallampati score was assessed clinically. Sleep was evaluated using the Children Sleep Habits Questionnaire.

时间窗: All assessments are done at a single point

次要结局

  • Tongue mobility was measured using TRMR with tongue tip movements & assessed with the Quick Tongue Tie Tool. Intercanine, intermolar distances & molar relationship were measured using an intraoral scanner. Nasal breathing was tested with lips sealed with micropore tape for up to 180 seconds. Mallampati score was assessed clinically. Sleep was evaluated using the Children Sleep Habits Questionnaire.(All assessments are done at a single time)

研究者

发起方
Dr M S Saravanakumar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr M S Saravanakumar

Sri Venkateswara Dental College and Hospital

研究点 (1)

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