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Clinical Trials/NCT04729673
NCT04729673CompletedNot Applicable

Canine Occlusal Relationship Changes After Full Mouth Rehabilitation and Stainless-Steel Crown Placement Under General Anesthesia in A Group of Egyptian Children; Part 2: "A Before and After Study"

Cairo University2 sites in 1 country73 target enrollmentStarted: July 3, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
73
Locations
2
Primary Endpoint
Change in the canine occlusal relationship
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The aim of the study is to assess and compare canine occlusal relation in children with carious primary molars before they are treated by stainless steel crowns under general anesthesia and after their placement ,to evaluate the possibility and the time required for the post operative canine relation to resolve and how the treatment affects frequency and type of food intake.

Detailed Description

  1. 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.
  2. Two postgraduate students will be filling the patient's assessment chart as shown in appendices prior to treatment. They will measure the canine occlusal relation. The measurements will be made in the maximum intercuspation position (MIP) in the centric occlusion (CO) guided by the operators' hand.
  3. Before general anesthesia, an anesthesiologist and an internal medicine specialist will examine participating children, and the necessary preclinical tests will be requested.
  4. 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).
  5. The canine occlusal relationship of both upper and lower primary canines shall be determined by measuring the vertical dimension from the gingival zenith of the upper canine and the gingival zenith of the lower canine at the right and left sides.
  6. The distance shall be determined using a digital caliper (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.).
  7. 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.
  8. The treatment will be performed under general anesthesia, tooth preparation will be done, and the eight Stainless-steel Crowns (3M™ ESPE™ Stainless Steel Primary Molar Crowns) will be seated.
  9. The measured values will be recorded preoperatively and immediately after the treatment while the patient is unconscious.
  10. Pre-operative determination of the canine occlusal relation of the upper and lower primary canines will be done; after placement during the operation and after 1, 2 and 6 months follow up period.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
2 Years to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Medical history: normal healthy children with no physical or mental disorders.
  • •Gender: No sex predilection.
  • •Age: children from (2 to 6) years old showing uncooperative behavior.
  • •Teeth: Carious teeth requiring oral dental rehabilitation under general requiring SSCs placement for primary molars.

Exclusion Criteria

  • •Children with special health care needs or with systemic conditions
  • •Decayed primary canines with severe caries involving more than one-third of the incisal and palatal surfaces, class IV or V, crowns being built up or any incisal edge involvement.
  • •Parafunctional occlusion, i.e., Crossbite.
  • •Erupted permanent first molar.
  • •Malocclusion.
  • •Refusal of participation.

Outcomes

Primary Outcomes

Change in the canine occlusal relationship

Time Frame: Day 1

The change of the canine occlusal relationship in millimeters using digital caliper

Secondary Outcomes

  • The time needed for the bite to re-adapt(''6 months")

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nourhan Kamal

Principal Investigator

Cairo University

Study Sites (2)

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