NCT04731337

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 anaesthesia and after their placement, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 29, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

July 3, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

August 7, 2023

Status Verified

August 1, 2023

Enrollment Period

1.1 years

First QC Date

January 24, 2021

Last Update Submit

August 3, 2023

Conditions

Full Mouth RehabilitationCanine Overlap RelationGeneral Anesthesia

Outcome Measures

Primary Outcomes (4)

  • Change in the canine occlusal relationship

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

    Immediately

  • Change in the canine occlusal relationship

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

    4 weeks

  • Change in the canine occlusal relationship

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

    2 months

  • Change in the canine occlusal relationship

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

    6 months

Secondary Outcomes (6)

  • The time needed for the bite to re-adapt

    "4 weeks"

  • The time needed for the bite to re-adapt

    "2 months"

  • The time needed for the bite to re-adapt

    "6 months"

  • Child's proper masticatory function and discomfort

    4 weeks

  • Child proper masticatory function and discomfort

    2 months

  • +1 more secondary outcomes

Study Arms (2)

Patient's normal canine occlusal relationship

ACTIVE COMPARATOR

The distance between the gingival zenith from the upper to the lower deciduous canines was determined by the digital calliper in millimetres (Shenzhen Jiabaili Electronic Commerce Co., Ltd) (fig1,2,3) at the right and left sides and a digital camera photographed the reading (iPhone 11 dual 12 MP Ultra-Wide and wide camera, Apple Inc.).

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

Canine occlusal relationship after full mouth rehabilitation

SHAM COMPARATOR

The distance between the gingival zenith from the upper to the lower deciduous canines was determined by the digital calliper in millimetres (Shenzhen Jiabaili Electronic Commerce Co., Ltd) (fig1,2,3) at the right and left sides and a digital camera photographed the reading (iPhone 11 dual 12 MP Ultra-Wide and wide camera, Apple Inc.).

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

Interventions

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

Measuring the vertical distance between the tip of the upper and lower canine teeth.

Canine occlusal relationship after full mouth rehabilitationPatient's normal canine occlusal relationship

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Medical history: Normal healthy Egyptian children with no physical or mental disorders.
  • Gender: No sex predilection.
  • Age: Children from (2 to 6) years old show uncooperative behaviour.
  • Teeth: Carious teeth requiring oral dental rehabilitation under general requiring SSCs placement for primary molars.
  • Canine relationship class Ⅰ.

You may not qualify if:

  • 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.
  • Erupted permanent first molar.
  • Malocclusion i.e., Cross bite, Open bite.
  • Canine relation class Ⅱ, and Ⅲ
  • Parafunctional habits.
  • Refusal of participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry-Cairo University

Cairo, Giza Governorate, 11553, Egypt

Location

Study Officials

  • Passant Nagi, PhD

    Passant.nagi@dentistry.cu.edu.eg

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 24, 2021

First Posted

January 29, 2021

Study Start

July 3, 2021

Primary Completion

August 1, 2022

Study Completion

March 1, 2023

Last Updated

August 7, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)