Skip to main content
OpenTrials
Completed

NCT Number: NCT04729673

Canine Occlusal Relationship Changes After Full Mouth Rehabilitation Under General Anesthesia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Giza, Select A State Or Province, 12345, Egypt

About this study

  • 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 occlusal relation. The measurements will be made in the maximum intercuspation position (MIP) in the centric occlusion (CO) guided by the operators' hand.
  • Before general anesthesia, 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 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.
  • 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.).
  • 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 anesthesia, 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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digital Caliper (Shenzhen Jiabaili Electronic Commerce Co., Ltd)

Device

Measuring the vertical distance between the gingival zenith of the upper canine to the gingival zenith of the lower canine

Primary outcomes

  1. Change in the canine occlusal relationship

    Time frame: Day 1

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

Secondary outcomes

  1. The time needed for the bite to re-adapt

    Time frame: ''1 month"

    The time needed for the bite to re-adapt throughout days using digital caliper

  2. The time needed for the bite to re-adapt

    Time frame: ''2 months"

    The time needed for the bite to re-adapt throughout days using digital caliper

  3. The time needed for the bite to re-adapt

    Time frame: ''6 months"

    The time needed for the bite to re-adapt throughout days using digital caliper

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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"

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 28, 2021
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.