General AnesthesiaNCT04729673
Canine Occlusal Relationship Changes After Full Mouth Rehabilitation Under General Anesthesia
A study testing Digital caliper (Shenzhen Jiabaili Electronic Commerce Co., Ltd) in people with General Anesthesia, run by Cairo University at 1 site in Egypt.
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 anesthesia and after their placement ,to evaluate the possibility and the time required for the post operative canine relation to resolve and… Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Digital caliper (Shenzhen Jiabaili Electronic Commerce Co., Ltd)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jul 2021to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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"
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.
Read the detailed description
- 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.
- Conditions
- General Anesthesia
- Being tested
- Digital caliper (Shenzhen Jiabaili Electronic Commerce Co., Ltd)
- Keywords
- Full mouth rehabilitation, Canine Overlap relation, vertical dimension of occlusion, canine occlusal relation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Patient's normal canine occlusal relationship. | Active comparator | 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.). Receives: Device: Digital caliper (Shenzhen Jiabaili Electronic Commerce Co., Ltd) |
| Canine occlusal relation after full mouth rehabilitation | Sham comparator | 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.). Receives: Device: Digital caliper (Shenzhen Jiabaili Electronic Commerce Co., Ltd) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the canine occlusal relationship
The change of the canine occlusal relationship in millimeters using digital caliper
Measured: Day 1
Secondary outcomes (3)
The time needed for the bite to re-adapt
The time needed for the bite to re-adapt throughout days using digital caliper
Measured: ''1 month"
The time needed for the bite to re-adapt
The time needed for the bite to re-adapt throughout days using digital caliper
Measured: ''2 months"
The time needed for the bite to re-adapt
The time needed for the bite to re-adapt throughout days using digital caliper
Measured: ''6 months"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start3 Jul 2021
- Primary completion1 Aug 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Kamal, Cairo University
- Investigators
- PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729673
- Sponsor's protocol ID
- 14422019435625
- Status last verified
- Aug 2023
- First submitted
- 25 Jan 2021
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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"
- ClinicalTrials.gov ID
- NCT04729673
- Acronym / sponsor ID
- 14422019435625
- Conditions
- General Anesthesia
- Keywords
- Full mouth rehabilitation, Canine Overlap relation, vertical dimension of occlusion, canine occlusal relation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jul 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient's normal canine occlusal relationship. | Active comparator | Device: Digital caliper (Shenzhen Jiabaili Electronic Commerce Co., Ltd)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.). |
| Canine occlusal relation after full mouth rehabilitation | Sham comparator | Device: Digital caliper (Shenzhen Jiabaili Electronic Commerce Co., Ltd)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.). |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Canine occlusal relation after full mouth rehabilitation, Patient's normal canine occlusal relationship. |
Primary outcome
Change in the canine occlusal relationship
Time frame: Day 1
The change of the canine occlusal relationship in millimeters using digital caliper
3 secondary outcomes
The time needed for the bite to re-adapt
Time frame: ''1 month"
The time needed for the bite to re-adapt
Time frame: ''2 months"
The time needed for the bite to re-adapt
Time frame: ''6 months"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PhD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital caliper (Shenzhen Jiabaili Electronic Commerce Co., Ltd) in people with General Anesthesia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the canine occlusal relationship (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.