Full Mouth RehabilitationNCT04731337
Canine Occlusal Relationship Changes After Stainless-Steel Crown Placement Under General Anesthesia
A study testing Digital Caliper (Shenzhen Jiabaili Electronic Commerce Co., Ltd) in people with Full Mouth Rehabilitation and Canine Overlap Relation, 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 anaesthesia and after their placement, evaluate the possibility and the time required for the post-operative canine relation to resolve and how… Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Full Mouth Rehabilitation, Canine Overlap Relation, 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
- 178 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 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.
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.
- Erupted permanent first molar.
- Malocclusion i.e., Cross bite, Open bite.
- Canine relation class Ⅱ, and Ⅲ
- Parafunctional habits.
- Refusal of participation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dentistry-Cairo University
Cairo, Giza Governorate, 11553
About this study
Official title: Canine Occlusal Relationship Changes After Full Mouth Rehabilitation and Stainless-Steel Crown Placement Under General Anesthesia in Group of Egyptian Children; Part 1: "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 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.
Read the detailed description
- The vertical overlap was determined after closing both arches in maximum intercuspation, intruding the tongue inwards away from the occlusal surfaces.
- After The patient had been anaesthetised, the measured values were recorded preoperatively and immediately after the treatment while the patient was unconscious.
- 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.
- 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.).
- 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).
- 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.
- 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.
- 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.
- 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.
- Relief of symptoms and improvement of type and frequency of food intake were assessed by asking the parents.
- Being tested
- Digital Caliper (Shenzhen Jiabaili Electronic Commerce Co., Ltd)
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 tip of the upper and lower canine teeth.
| Study group | Role | What they receive |
|---|---|---|
| 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.). Receives: 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.). 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 in the canine occlusal relationship in millimeters using digital caliper
Measured: Immediately
Change in the canine occlusal relationship
The change in the canine occlusal relationship in millimeters using digital caliper
Measured: 4 weeks
Change in the canine occlusal relationship
The change in the canine occlusal relationship in millimeters using digital caliper
Measured: 2 months
Change in the canine occlusal relationship
The change in the canine occlusal relationship in millimeters using digital caliper
Measured: 6 months
Secondary outcomes (6)
The time needed for the bite to re-adapt
The time needed for the bite to re-adapt using digital caliper throughout days.
Measured: "4 weeks"
The time needed for the bite to re-adapt
The time needed for the bite to re-adapt using digital caliper throughout days.
Measured: "2 months"
The time needed for the bite to re-adapt
The time needed for the bite to re-adapt using digital caliper throughout days.
Measured: "6 months"
Child's proper masticatory function and discomfort
Child proper masticatory function and discomfort by questioning the parents.
Measured: 4 weeks
Child proper masticatory function and discomfort
Child proper masticatory function and discomfort by questioning the parents.
Measured: 2 months
Child proper masticatory function and discomfort
Child proper masticatory function and discomfort by questioning the parents.
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 posted29 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 Full Mouth RehabilitationStudies 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
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olaya Amr Moustafa Ez ElArab ElBahnacy, Cairo University
- Investigators
- Passant Nagi, PhD, Study director, Passant.nagi@dentistry.cu.edu.eg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731337
- Sponsor's protocol ID
- 14422019452661
- Status last verified
- Aug 2023
- First submitted
- 24 Jan 2021
- Last updated
- 7 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 7 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 Group of Egyptian Children; Part 1: "Before and After Study".
- ClinicalTrials.gov ID
- NCT04731337
- Acronym / sponsor ID
- 14422019452661
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 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
- 29 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 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.
Detailed description
- The vertical overlap was determined after closing both arches in maximum intercuspation, intruding the tongue inwards away from the occlusal surfaces.
- After The patient had been anaesthetised, the measured values were recorded preoperatively and immediately after the treatment while the patient was unconscious.
- 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.
- 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.).
- 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).
- 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.
- 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.
- 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.
- 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.
- Relief of symptoms and improvement of type and frequency of food intake were assessed by asking the parents.
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)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.). |
| Canine occlusal relationship after full mouth rehabilitation | Sham comparator | Device: Digital Caliper (Shenzhen Jiabaili Electronic Commerce Co., Ltd)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.). |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 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.
- Erupted permanent first molar.
- Malocclusion i.e., Cross bite, Open bite.
- Canine relation class Ⅱ, and Ⅲ
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 tip of the upper and lower canine teeth. | Device | Canine occlusal relationship after full mouth rehabilitation, Patient's normal canine occlusal relationship |
Primary outcome
Change in the canine occlusal relationship
Time frame: Immediately
The change in the canine occlusal relationship in millimeters using digital caliper
Change in the canine occlusal relationship
Time frame: 4 weeks
The change in the canine occlusal relationship in millimeters using digital caliper
Change in the canine occlusal relationship
Time frame: 2 months
The change in the canine occlusal relationship in millimeters using digital caliper
Change in the canine occlusal relationship
Time frame: 6 months
The change in the canine occlusal relationship in millimeters using digital caliper
6 secondary outcomes
The time needed for the bite to re-adapt
Time frame: "4 weeks"
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"
Child's proper masticatory function and discomfort
Time frame: 4 weeks
Child proper masticatory function and discomfort
Time frame: 2 months
Child proper masticatory function and discomfort
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 7 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.
Passant Nagi, PhD study director
Passant.nagi@dentistry.cu.edu.eg
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 Full Mouth Rehabilitation and Canine Overlap Relation, 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 5 inclusion and 7 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 7 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: Immediately). The study lists 4 primary outcomes in all. 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 7 Aug 2023.