Pulp Disease, DentalPhase 1/2NCT04650113
Clinical and Radiographic Assessment of Partial and Complete Pulpotomy in Primary Molars Using MTA
A Phase 1/2 study testing MTA material in people with Pulp Disease, Dental, run by Cairo University at 1 site in Egypt.
Trial summary
that's comparison between partial and complete pulpotomy techniques in primary teeth Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Disease, Dental
- What is being tested?
- MTA material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2021to 3 Sep 2021
- Phase
- Phase 1/2
- 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- - Medically free children who will be able and cooperative in all steps of the study.
- - Asymptomatic primary molars with a deep carious lesion.
- - Vital pulp due to dental caries with no clinical sign of pulpal degeneration (spontaneous pain, fistula, mobility) prior to treatment.
- 3 - Preliminary radiographs indicating absence of pathologic internal or external root resorption, or any evidence of inter-radicular bone destruction.
- 4 - Absence of pre-operative pain or they will only have a short-term pain. 5 - No tenderness to percussion. 6-Age ranging 4-6 years.
Who cannot join
- 1- Excessive bleeding during pulp amputation. 2 - Non vital teeth. 3 -History of spontaneous or prolonged pain. 4 - Swelling, tenderness, to percussion or palpation, or pathologic mobility. 5 - pre-operative radiographic pathology such as resorption (internal, external); periradicular or furcation radiolucency, or a widened periodontal ligament space.
- 6 - Parent or guardians who refuse participating in the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dentistry cairo university
Al Manyal, Cairo Governorate, 11562
fatma abdelraouf, Bsc, 00201060771955, fatmaraouf.fr@gmail.com
Rasha Ragab, 00 20 100 7505888, Rashaadelragab@gmail.com
About this study
Official title: Clinical and Radiographic Assessment of Partial and Complete Pulpotomy in Primary Molars Using MTA : A Randomized Clinical Trial
that's comparison between partial and complete pulpotomy techniques in primary teeth
- Conditions
- Pulp Disease, Dental
- Being tested
- MTA material
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTA materialCombination product
Also called partial pulpotomy procedure
Partial pulpotomy is a procedure in which the inflamed tissue beneath an exposure is removed to a depth of 1 to 3 mm or deeper to reach healthy pulp tissue.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | placed with light pressure over the pulpal stumps (if hemorrhage control will not be achieve, tooth will be exclude ) 9.The pellet will be remove, and the pulp chamber filled with MTA. 10.The tooth will prepare and restore with a stainless steel crown cemented with glass ionomer cement Receives: Combination Product: MTA material |
| group B | Active comparator | 1. Pre-operative radiograph showing all roots and their apices.
2. Local anesthesia will be administered and a rubber dam will take place ,that ensure good isolation of the treated teeth.
3. Removal of caries
4. Pulp chambers will access using a no.330 bur in a high-speed hand piece with water coolant.
5. Removal of any remains of coronal pulp tissue with sharp sterile excavator or large bur in slow hand piece
6. Pulp amputation will perform using a spoon excavator.
7. Hemorrhage control will obtain within 5 minutes using sterile cotton pellets placed with light pressure over the pulpal stumps (if hemorrhage control will not be achieve, tooth will be exclude )
8. The pellet will be remove, and the pulp chamber will be filled with MTA.
9. The tooth will prepare and restore with a stainless steel crown cemented with glass ionomer cement.
The periapical radiographic will be taken at this baseline visit . Receives: Combination Product: MTA material |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
analog scale
Measured: 1 week
postoperative pain
analog scale
Measured: 1 month
postoperative pain
analog scale
Measured: 3 months
postoperative pain
analog scale
Measured: 6 months
swelling
clinical examination
Measured: 1 week
swelling
clinical examination
Measured: 1 month
swelling
clinical examination
Measured: 3 months
swelling
clinical examination
Measured: 6 months
mobility
clinical examination
Measured: 1 week
mobility
clinical examination
Measured: 1 month
mobility
clinical examination
Measured: 3 months
mobility
clinical examination
Measured: 6 months
Secondary outcomes (8)
root resorption
periapical radiograph
Measured: 1 week
root resorption
periapical radiograph
Measured: 1 month
root resorption
periapical radiograph
Measured: 3 months
root resorption
periapical radiograph
Measured: 6 months
Bone resorption
periapical radiograph
Measured: 1 week
Bone resorption
periapical radiograph
Measured: 1 month
Bone resorption
periapical radiograph
Measured: 3 months
Bone resorption
periapical radiograph
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 posted2 Dec 2020
- Study start20 Jan 2021 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion3 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp Disease, DentalStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fatma zainalabdieen abdelraouf, Cairo University
- Investigators
- adel El-bardissy, prof, Study director, Associate Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry cairo universityrasha ragab, phd, Study director, Lecturer of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650113
- Sponsor's protocol ID
- CARopacpIPMUM
- Status last verified
- Nov 2020
- First submitted
- 18 Nov 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Assessment of Partial and Complete Pulpotomy in Primary Molars Using MTA : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04650113
- Acronym / sponsor ID
- CARopacpIPMUM
- Conditions
- Pulp Disease, Dental
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jan 2021 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 3 Sep 2021 (estimated)
- First posted
- 2 Dec 2020 (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.
that's comparison between partial and complete pulpotomy techniques in primary teeth
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Combination Product: MTA materialplaced with light pressure over the pulpal stumps (if hemorrhage control will not be achieve, tooth will be exclude ) 9.The pellet will be remove, and the pulp chamber filled with MTA. 10.The tooth will prepare and restore with a stainless steel crown cemented with glass ionomer cement |
| group B | Active comparator | Combination Product: MTA material1. Pre-operative radiograph showing all roots and their apices. 2. Local anesthesia will be administered and a rubber dam will take place ,that ensure good isolation of the treated teeth. 3. Removal of caries 4. Pulp chambers will access using a no.330 bur in a high-speed hand piece with water coolant. 5. Removal of any remains of coronal pulp tissue with sharp sterile excavator or large bur in slow hand piece 6. Pulp amputation will perform using a spoon excavator. 7. Hemorrhage control will obtain within 5 minutes using sterile cotton pellets placed with light pressure over the pulpal stumps (if hemorrhage control will not be achieve, tooth will be exclude ) 8. The pellet will be remove, and the pulp chamber will be filled with MTA. 9. The tooth will prepare and restore with a stainless steel crown cemented with glass ionomer cement. The periapical radiographic will be taken at this baseline visit . |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- - Medically free children who will be able and cooperative in all steps of the study.
- - Asymptomatic primary molars with a deep carious lesion.
- - Vital pulp due to dental caries with no clinical sign of pulpal degeneration (spontaneous pain, fistula, mobility) prior to treatment.
- 3 - Preliminary radiographs indicating absence of pathologic internal or external root resorption, or any evidence of inter-radicular bone destruction.
- 4 - Absence of pre-operative pain or they will only have a short-term pain. 5 - No tenderness to percussion. 6-Age ranging 4-6 years.
Key exclusion criteria (2 listed)
- 1- Excessive bleeding during pulp amputation. 2 - Non vital teeth. 3 -History of spontaneous or prolonged pain. 4 - Swelling, tenderness, to percussion or palpation, or pathologic mobility. 5 - pre-operative radiographic pathology such as resorption (internal, external); periradicular or furcation radiolucency, or a widened periodontal ligament space.
- 6 - Parent or guardians who refuse participating in the study
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 |
|---|---|---|
| MTA materialAlso: partial pulpotomy procedurePartial pulpotomy is a procedure in which the inflamed tissue beneath an exposure is removed to a depth of 1 to 3 mm or deeper to reach healthy pulp tissue. | Combination product | group A, group B |
Primary outcome
postoperative pain
Time frame: 1 week
analog scale
postoperative pain
Time frame: 1 month
analog scale
postoperative pain
Time frame: 3 months
analog scale
postoperative pain
Time frame: 6 months
analog scale
swelling
Time frame: 1 week
clinical examination
swelling
Time frame: 1 month
clinical examination
swelling
Time frame: 3 months
clinical examination
swelling
Time frame: 6 months
clinical examination
mobility
Time frame: 1 week
clinical examination
mobility
Time frame: 1 month
clinical examination
mobility
Time frame: 3 months
clinical examination
mobility
Time frame: 6 months
clinical examination
8 secondary outcomes
root resorption
Time frame: 1 week
root resorption
Time frame: 1 month
root resorption
Time frame: 3 months
root resorption
Time frame: 6 months
Bone resorption
Time frame: 1 week
Bone resorption
Time frame: 1 month
Bone resorption
Time frame: 3 months
Bone resorption
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Pulp Disease, Dental
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Active, not recruiting
Multiple-Visit RCT in Teeth With SAP: Interappointment Dressing or Not?
Endodontically Treated Teeth, Calcium Hydroxide
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.
adel El-bardissy, prof study director
Associate Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry cairo university
rasha ragab, phd study director
Lecturer of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MTA material in people with Pulp Disease, Dental, 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 2 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: status not confirmed, as of the sponsor's last update on 2 Dec 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact fatma abdelraouf, Msc (00201060771955, fatmaraouf.fr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: 1 week). The study lists 12 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 2 Dec 2020.