Assessment of sleep disturbances and dental malalignments in six to twelve year old children

Completed

• Conditions: Disorder of teeth and supporting structures, unspecified,

• Registration Number: CTRI/2018/12/016759
• Lead Sponsor: Dr Shweta Shirke

Brief Summary

In our study we are goingto assess the association of Sleep Disordered Breathing (SDB) and developingmalocclusion in six to twelve year old children. A written consentshall be obtained from the parent/s of children prior to the beginning of thestudy. 161 patients i.e. 6-12 year old children attending theOPD of the Dept. of Paediatric and Preventive Dentistry will be assessed forpresence or absence of SDB through a 31 point questionnaire and type ofdeveloping Angle’s malocclusion.Complete general and oral examination will beperformed using appropriate instruments. Tonsillar enlargement will be assessedusing Brodsky’s criteria. Other variables such as degree of lingual mobility,maxillary frenal attachment, palatal depth will be alsoassessed. Impressions will be made and study models will be prepared andwill be assessed for IOTN grades. IOTN index comprises of 5 grades, based ongrades of treatment need. Relevant treatment will be given to the patients free of cost.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study Completion: 2019-05-15
• Last Update Posted: 2021-12-04

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

• 1. Healthy children between the age group of 6 – 12 years.
• 2. Children with mixed dentition.

Exclusion Criteria

• 1. Children undergoing or completed orthodontic treatment.
• 2. Children with developmental syndromes like cleft lip and/or palate, etc.
• 3. Children in whom tonsillectomy/adenoidectomy has been performed.
• 4. Children undergoing medical care and presenting some type of neurological, neuromuscular or motor disturbances that would hinder their participation.
• 5. Children whose parents refused to give consent.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. SDB	From 8/12/2018 to 30/04/2018 | 1. SDB (present or absent) | 2.Type of Angle’s malocclusion (class I, class II, class III) | 3.IOTN grade (GRADE 1-5)
2.Type of Angle’s malocclusion	From 8/12/2018 to 30/04/2018 | 1. SDB (present or absent) | 2.Type of Angle’s malocclusion (class I, class II, class III) | 3.IOTN grade (GRADE 1-5)
3.IOTN grade	From 8/12/2018 to 30/04/2018 | 1. SDB (present or absent) | 2.Type of Angle’s malocclusion (class I, class II, class III) | 3.IOTN grade (GRADE 1-5)

Secondary Outcome Measures

Name	Time	Method
1.Age	2.Gender

Trial Locations

Locations (1)

Dr. G. D. Pol Foundation Y.M.T Dental College and Hospital; 🇮🇳 Raigarh, MAHARASHTRA, India

Dr. G. D. Pol Foundation Y.M.T Dental College and Hospital

🇮🇳Raigarh, MAHARASHTRA, India

Dr Amar Katre

Principal investigator

9821540186

amar_katre@hotmail.com