Canine Occlusal Relationship Changes After Full Mouth Rehabilitation Under General Anesthesia

NCT ID: NCT04729673

Last Updated: 2023-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-03
• Study Completion Date: 2023-03-01

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.

Conditions

General Anesthesia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Patient's normal canine occlusal relationship.

Before full mouth rehabilitation with stainless steel crowns for primary molars , the vertical dimension of occlusion from gingival zenith of upper and lower primary canines shall be determined 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.).

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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

Canine occlusal relation after full mouth rehabilitation

After full mouth rehabilitation with stainless steel crowns for primary molars , the vertical dimension of occlusion from gingival zenith of upper and lower primary canines shall be determined 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.).

Group Type: SHAM_COMPARATOR

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

Intervention Type: DEVICE

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

Interventions

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

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nourhan Kamal

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

PhD

Role: STUDY_DIRECTOR

Cairo University

Locations

Cairo University

Giza, Select A State Or Province, Egypt

Countries

Egypt

Other Identifiers

14422019435625

Identifier Type: -

Identifier Source: org_study_id