Clinical Evaluation Including Pain and SwellingNCT04710160
Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Protooth Vs. MTA
A study testing Novel fast-setting calcium silicate cement (Protooth) in people with Clinical Evaluation Including Pain and Swelling, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the clinical and radiographic success in pulpotomy using novel fast-setting calcium silicate cement (Protooth) versus MTA in exposed primary molars. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Evaluation Including Pain and Swelling
- What is being tested?
- Novel fast-setting calcium silicate cement (Protooth)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2021to Nov 2022
- 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Complete physical and mental health, with no confounding history of systemic disease and/or use of special local or systemic drugs
- No allergic reactions recorded in patient history
- Having primary molar teeth in one jaw, having deep caries and vital pulp.
- No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of vestibule
- Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test
- Radiographic criteria:
Show all 9Show fewer
- No sign of radiolucency in periapical or furcation area
- No widening of PDL space or loss of lamina dura continuity
- No evidence of internal/external pathologic root resorption
Who cannot join
- Lack of informed consent by the child patient's parent
- Lack of informed consent by the child patient's parent
- Unable to attend follow-up visits.
- Refusal of participation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentsitry , Cairo University
Cairo, El Manial, 11553
Adel Elbardissy, Professor, 01271289999, adelbardissy@dentistry.cu.edu.eg
Passant Nagy, Doctorat, 01280557107, passant.nagi@dentistry.cu.edu.eg
About this study
Official title: Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Novel Fast-setting Calcium Silicate Cement (Protooth) Versus Mineral Trioxide Aggregate (MTA): A Pilot Study
The aim of the study is to evaluate the clinical and radiographic success in pulpotomy using novel fast-setting calcium silicate cement (Protooth) versus MTA in exposed primary molars.
- Being tested
- Novel fast-setting calcium silicate cement (Protooth)
- Keywords
- Pulpotomy , Primary molars , Protooth , MTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel fast-setting calcium silicate cement (Protooth)Drug
Also called mineral trioxide aggregate (MTA )
In form of power and liquid to be mixed together to form a paste.
| Study group | Role | What they receive |
|---|---|---|
| Novel fast setting calcium silicate ( Protooth) | Active comparator | In the form of powder and liquid to be mixed together to form paste. Receives: Drug: Novel fast-setting calcium silicate cement (Protooth) |
| MTA | Experimental | In form of powder to be mixed with saline to form paste. Receives: Drug: Novel fast-setting calcium silicate cement (Protooth) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation including postoperative pain , pain on percussion or palpation will be measured using VAS
Post-operative pain following pulpotomy treatment will be measured.
A pain chart using visual analogue scale (VAS) will be used to record the patients' pain levels. The VAS (0-10 scale) consists of a line anchored by two extremes "No pain" and "the worst pain". Patients will be asked to choose the mark that represented their level of pain from 0 to 10. Pain level will be assigned as follow:
0, "no pain" 1-3, "mild pain" 4-6, "moderate pain" 7-10, "severe pain" Using the VAS chart, the patient will choose and record the most appropriate pain rating according to the pain intensity endured.
Measured: 12 months
Secondary outcomes (1)
Radiographic evaluation following the Pulpotomy treatment will be measured
Binary assessment of the radiographs taken after the treatment ( if there is any radiolucent or widening in the lamina sure nor evidence of internal/external pathologic root resorption)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study startAug 2021 (estimated)
- Primary completion22 Oct 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Evaluation Including Pain and SwellingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nashwa Ossama Ahmed Elshaer, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710160
- Sponsor's protocol ID
- Pedo193
- Status last verified
- Aug 2021
- First submitted
- 12 Jan 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Novel Fast-setting Calcium Silicate Cement (Protooth) Versus Mineral Trioxide Aggregate (MTA): A Pilot Study
- ClinicalTrials.gov ID
- NCT04710160
- Acronym / sponsor ID
- Pedo193
- Keywords
- Pulpotomy , Primary molars , Protooth , MTA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- 22 Oct 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 14 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 evaluate the clinical and radiographic success in pulpotomy using novel fast-setting calcium silicate cement (Protooth) versus MTA in exposed primary molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel fast setting calcium silicate ( Protooth) | Active comparator | Drug: Novel fast-setting calcium silicate cement (Protooth)In the form of powder and liquid to be mixed together to form paste. |
| MTA | Experimental | Drug: Novel fast-setting calcium silicate cement (Protooth)In form of powder to be mixed with saline to form paste. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Complete physical and mental health, with no confounding history of systemic disease and/or use of special local or systemic drugs
- No allergic reactions recorded in patient history
- Having primary molar teeth in one jaw, having deep caries and vital pulp.
- No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of vestibule
- Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test
Key exclusion criteria (4 listed)
- Lack of informed consent by the child patient's parent
- Lack of informed consent by the child patient's parent
- Unable to attend follow-up visits.
- Refusal of participation.
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 |
|---|---|---|
| Novel fast-setting calcium silicate cement (Protooth)Also: mineral trioxide aggregate (MTA )In form of power and liquid to be mixed together to form a paste. | Drug | MTA, Novel fast setting calcium silicate ( Protooth) |
Primary outcome
Clinical evaluation including postoperative pain , pain on percussion or palpation will be measured using VAS
Time frame: 12 months
Post-operative pain following pulpotomy treatment will be measured. A pain chart using visual analogue scale (VAS) will be used to record the patients' pain levels. The VAS (0-10 scale) consists of a line anchored by two extremes "No pain" and "the worst pain". Patients will be asked to choose the mark that represented their level of pain from 0 to 10. Pain level will be assigned as follow: 0, "no pain" 1-3, "mild pain" 4-6, "moderate pain" 7-10, "severe pain" Using the VAS chart, the patient will choose and record the most appropriate pain rating according to the pain intensity endured.
1 secondary outcome
Radiographic evaluation following the Pulpotomy treatment will be measured
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel fast-setting calcium silicate cement (Protooth) in people with Clinical Evaluation Including Pain and Swelling, 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 9 inclusion and 4 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 5 Aug 2021. 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.
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 Adel Elbardissy, professor (01271289999, adelbardissy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation including postoperative pain , pain on percussion or palpation will be measured using VAS (time frame: 12 months). 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 5 Aug 2021.