Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Canine Overlap Relation
  • Full Mouth Rehabilitation
  • General Anesthesia
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Screening

Participation Requirements

Age
Between 4 years and 6 years
Gender
Both males and females

Description

Children who require immediate full mouth rehabilitation under general anaesthesia will be recruited from the General Anesthesia (GA) unit in the Department of Pediatric Dentistry, Faculty of Oral and Dental Medicine, Cairo University. Two postgraduate students will be filling the patient's assessme...

Children who require immediate full mouth rehabilitation under general anaesthesia will be recruited from the General Anesthesia (GA) unit in the Department of Pediatric Dentistry, Faculty of Oral and Dental Medicine, Cairo University. Two postgraduate students will be filling the patient's assessment chart as shown in appendices prior to treatment. They will measure the canine overlap. The measurements will be made in the maximum intercuspation position (MIP) in the centric occlusion (CO) guided by the operators' hand. Before general anaesthesia, an anesthesiologist and an internal medicine specialist will examine participating children, and the necessary preclinical tests will be requested. On the day of the procedure, parents of the participants will fill a questionnaire asking for previous dental treatments of the child and his/her medical history and acceptance to join the study (written consent). The vertical overlap of both upper and lower primary canines shall be determined by locating the meeting tip of the cusp of the upper primary canine over the lower primary canine at the right and left sides using a sharp pencil. The distance from this point to the tip of the lower primary canine shall be determined using a digital calliper (Shenzhen Jiabaili Electronic Commerce Co., Ltd), and the reading will be photographed by a digital camera (iPhone 11 dual 12 MP Ultra-Wide and wide camera, Apple Inc.). The highest part of the drawn line will be considered as the reference line. For further accuracy, this will be repeated twice, and in case of the presence of a difference, the measurement will be repeated for the third time, and the mean of the values will be calculated. The treatment will be performed under general anaesthesia, tooth preparation will be done, and the eight Stainless-steel Crowns (3M™ ESPE™ Stainless Steel Primary Molar Crowns) will be seated. The measured values will be recorded preoperatively and immediately after the treatment while the patient is unconscious. Pre-operative determination of the vertical overlap of the upper and lower primary canines will be done; after placement during the operation and after 2, 4 months follow up period. If the pre-operative overlap is not restored after four months, we will continue to follow up for six months.

Tracking Information

NCT #
NCT04731337
Collaborators
Not Provided
Investigators
Not Provided