Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04731337 |
| Other study ID # |
14422019452661 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 3, 2021 |
| Est. completion date |
March 1, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
1. The vertical overlap was determined after closing both arches in maximum intercuspation,
intruding the tongue inwards away from the occlusal surfaces.
2. After The patient had been anaesthetised, the measured values were recorded
preoperatively and immediately after the treatment while the patient was unconscious.
3. In order to achieve the maximum intercuspal position (MIP) at centric occlusion, it is
recommended to gently push the tongue while using a metal spatula to close the patient's
mouth.
4. 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) 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.).
5. The tooth is anesthetised, demineralised dentine will be removed, and if a pulpotomy or
pulpectomy is needed (pulpotomy with Zinconol; Dentsply Sirona, Charlotte, NC, USA) and
the subsequent restoration is with high-viscosity glass ionomer cement (GIC), The tooth
will be prepared by occlusal, proximal reduction and; an SCC (3M™ ESPE™ Stainless Steel
Primary Molar Crowns) will be tried and adjusted to fit the tooth. The size of the PMC
that is tight enough to give a feeling of 'spring back' during seating should be
selected. Occlusion is checked, and the SSC will be sealed with a GIC (CVI Fuji Plus;
GC).
6. Pre-operative determination of the vertical overlap of the upper and lower primary
canines was done; after placement during the operation, four weeks, 2, and 6-month
follow-up period.
7. Tooth preparation was done according to the principles of Spedding *1 to have 1-mm
clearance between the respective tooth and the opposing tooth, and SSCs (3M ESPE, St.
Paul, MN, USA) were seated, and then the operator checked occlusion.
8. After discharging the patient from the recovery room and re-establishment the function
of the facial muscles, a questionnaire was taken from the parent assessing the
preoperative state of the patient regarding pain and discomfort, swelling and type and
frequency of food intake.
9. As part of the measurement process, a single individual was responsible for capturing
the readings while another person was documenting the results with a camera. This
protocol was established to ensure accuracy and consistency in the results obtained and
maintain a clear measurement record.
10. Relief of symptoms and improvement of type and frequency of food intake were assessed by
asking the parents.
