Reversible PulpitisNCT04617600
Survival Rate After TheraCal PT Pulpotomy Versus MTA Pulpotomy in Children With Vital Primary Molars.
A study testing MTA and TheraCal PT in people with Reversible Pulpitis, run by Cairo University.
Trial summary
The aim of the study is to assess the effect of TheraCal PT pulpotomy versus MTA pulpotomy on the survival rate of cariously exposed vital primary molars. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Reversible Pulpitis
- What is being tested?
- MTA and TheraCal PT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 1 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 4 to 7 years , in good general health and mentally free.
- The parents provided written informed consent.
- Cariously exposed primary molars with reversible pulpitis.
- Teeth should be vital.
- Restorable teeth.
- Hemostasis achieved after complete pulpotomy
Who cannot join
- With systemic disease.
- Physical or mental disability.
- Unable to attend follow-up visits.
- Refusal of participation.
- Previously accessed teeth.
- History of spontaneous or prolonged pain.
Show all 9Show fewer
- Swelling, tenderness to percussion or palpation, or pathological mobility.
- Pre-operative radiographic pathology such as resorption(internal or external),per-radicular or furcation radiolucency.
- Haemorrhage control is unachievable after pulpotomy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Survival Rate After TheraCal PT Pulpotomy Versus MTA Pulpotomy in Children With Vital Primary Molars: A Randomized Controlled Pilot Trial.
The aim of the study is to assess the effect of TheraCal PT pulpotomy versus MTA pulpotomy on the survival rate of cariously exposed vital primary molars.
Read the detailed description
for both interventions ,
- Informed consent from participating parents.
- Baseline records photographs, percussion test, periapical radiograph and personal data collection.
- Allocation (concealed by withdrawing a sealed opaque envelope containing eight times folded paper containing the type of dressing material that will be used then writing patient name and I.D. on it and will be opened after performing the access cavity).
- Diagnostic chart with personal, medical and dental history will be filled.
- Clinical examination will be performed to assess the clinical inclusion criteria. (Pulpal and periapical diagnosis is established after clinical examination).
- Preoperative and Postoperative photographs will be taken.
- The radiographic examination will be performed by taking periapical x-ray using (parallel technique) through machine to assess the inclusion criteria. The preoperative radiograph will serve as a reference for the follow-up radiographs. Standardization of the technique to avoid any distortion in the vertical dimension and to provide reproducible images using x-ray holding device.
- Preoperative and postoperative radiograph will be taken by parallel technique using extension cone paralleling (XCP) film holder.
- Administration of inferior alveolar nerve block (Septodont, Scandonest® 2% L Mepivacaine hydrochloride (HCl). 2% and Levonordefrin 1:20,000 Injection, U.S.P.) at the side of the affected tooth.
- Application of rubber dam for isolation, then a standardized pulpotomy procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation, a sharp spoon excavator will remove pulpal tissues to the orifice level. Hemostasis will be achieved by the application of a wet cotton pellet.
Children will then be allocated into either one of the groups alternatively depending on the pulpotomy medicament used as follows:
- Group I (Experimental group) TheraCal PT pulpotomy.
- Group II (Control group) MTA pulpotomy.
Group I (Experimental group) TheraCal PT:
- After complete hemostasis, TheraCal PT (BISCO Dental Products, Schamberg illinois (IL), U.S.A.) will be applied according to the manufacturer's instructions and gently placed over the pulp stumps to a thickness of 2mm then the rest of the pulp chamber will be filled with glass ionomer cement.
- Tooth will then be restored with stainless steel crown.
Group II (Control group) MTA pulpotomy:
- After complete hemostasis, MTA+ Curamed (ul. Kwiatkowskiego 1, 37-450 stylosa Wola, Polka) will be manipulated in the ratio of 3:1 (powder: liquid) to obtain a putty mix. This mix will be placed over the radicular pulp with the help of a suitable sterile amalgam carrier. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet, followed by application of glass ionomer cement.
- Tooth will then be restored with stainless steel crown.
- Conditions
- Reversible Pulpitis
- Being tested
- MTA, TheraCal PT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTADrug
Also called Mineral trioxide aggregate
Survival rate using MTA in cariously exposed vital primary molars
TheraCal PTDrug
Also called TheraCal PT®
Survival rate using TheraCal PT in cariously exposed vital primary molars
| Study group | Role | What they receive |
|---|---|---|
| Mineral trioxide aggregate (MTA) | Active comparator | Survival rate of cariously exposed vital primary molars using MTA+ Curamed (UI, Kwiatkowskiego 1, 37-450 Staleya Wola, Polka) Receives: Drug: MTA |
| TheraCal PT | Experimental | Survival rate of cariously exposed vital primary molars using TheraCal PT (BISCO Dental Products, Schamberg IL, U.S.A.) Receives: Drug: TheraCal PT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate (Absence of spontaneous pain)
Binary outcome measured with direct questioning to the patient
Measured: "3 months"
Survival rate (Absence of spontaneous pain)
Binary outcome measured with direct questioning to the patient
Measured: "6 months"
Survival rate (Absence of swelling)
Binary outcome measured visually by intraoral/extraoral examination
Measured: "3 months"
Survival rate (Absence of swelling)
Binary outcome measured visually by intraoral/extraoral examination
Measured: "6 months"
Secondary outcomes (2)
Absence of periapical radiolucency or absence of internal/external root resorption
Binary outcome detected with periapical x-ray by parallel technique using XCP film holder (Super Bite, Hawe Neos DentalSA, Switzerland).
Measured: "6 months"
Time lapse till final restoration performed.
Continuous outcome measured with a Stopwatch in minutes.
Measured: "During procedure".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Mar 2022 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reversible PulpitisStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Mohamed Gaber, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617600
- Sponsor's protocol ID
- 14422019496708
- Status last verified
- Mar 2022
- First submitted
- 22 Oct 2020
- Last updated
- 4 Mar 2022
- 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 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Rate After TheraCal PT Pulpotomy Versus MTA Pulpotomy in Children With Vital Primary Molars: A Randomized Controlled Pilot Trial.
- ClinicalTrials.gov ID
- NCT04617600
- Acronym / sponsor ID
- 14422019496708
- Conditions
- Reversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 5 Nov 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.
The aim of the study is to assess the effect of TheraCal PT pulpotomy versus MTA pulpotomy on the survival rate of cariously exposed vital primary molars.
Detailed description
for both interventions ,
- Informed consent from participating parents.
- Baseline records photographs, percussion test, periapical radiograph and personal data collection.
- Allocation (concealed by withdrawing a sealed opaque envelope containing eight times folded paper containing the type of dressing material that will be used then writing patient name and I.D. on it and will be opened after performing the access cavity).
- Diagnostic chart with personal, medical and dental history will be filled.
- Clinical examination will be performed to assess the clinical inclusion criteria. (Pulpal and periapical diagnosis is established after clinical examination).
- Preoperative and Postoperative photographs will be taken.
- The radiographic examination will be performed by taking periapical x-ray using (parallel technique) through machine to assess the inclusion criteria. The preoperative radiograph will serve as a reference for the follow-up radiographs. Standardization of the technique to avoid any distortion in the vertical dimension and to provide reproducible images using x-ray holding device.
- Preoperative and postoperative radiograph will be taken by parallel technique using extension cone paralleling (XCP) film holder.
- Administration of inferior alveolar nerve block (Septodont, Scandonest® 2% L Mepivacaine hydrochloride (HCl). 2% and Levonordefrin 1:20,000 Injection, U.S.P.) at the side of the affected tooth.
- Application of rubber dam for isolation, then a standardized pulpotomy procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation, a sharp spoon excavator will remove pulpal tissues to the orifice level. Hemostasis will be achieved by the application of a wet cotton pellet.
Children will then be allocated into either one of the groups alternatively depending on the pulpotomy medicament used as follows:
- Group I (Experimental group) TheraCal PT pulpotomy.
- Group II (Control group) MTA pulpotomy.
Group I (Experimental group) TheraCal PT:
- After complete hemostasis, TheraCal PT (BISCO Dental Products, Schamberg illinois (IL), U.S.A.) will be applied according to the manufacturer's instructions and gently placed over the pulp stumps to a thickness of 2mm then the rest of the pulp chamber will be filled with glass ionomer cement.
- Tooth will then be restored with stainless steel crown.
Group II (Control group) MTA pulpotomy:
- After complete hemostasis, MTA+ Curamed (ul. Kwiatkowskiego 1, 37-450 stylosa Wola, Polka) will be manipulated in the ratio of 3:1 (powder: liquid) to obtain a putty mix. This mix will be placed over the radicular pulp with the help of a suitable sterile amalgam carrier. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet, followed by application of glass ionomer cement.
- Tooth will then be restored with stainless steel crown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mineral trioxide aggregate (MTA) | Active comparator | Drug: MTASurvival rate of cariously exposed vital primary molars using MTA+ Curamed (UI, Kwiatkowskiego 1, 37-450 Staleya Wola, Polka) |
| TheraCal PT | Experimental | Drug: TheraCal PTSurvival rate of cariously exposed vital primary molars using TheraCal PT (BISCO Dental Products, Schamberg IL, U.S.A.) |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged 4 to 7 years , in good general health and mentally free.
- The parents provided written informed consent.
- Cariously exposed primary molars with reversible pulpitis.
- Teeth should be vital.
- Restorable teeth.
Key exclusion criteria (9 listed)
- With systemic disease.
- Physical or mental disability.
- Unable to attend follow-up visits.
- Refusal of participation.
- Previously accessed teeth.
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 |
|---|---|---|
| MTAAlso: Mineral trioxide aggregateSurvival rate using MTA in cariously exposed vital primary molars | Drug | Mineral trioxide aggregate (MTA) |
| TheraCal PTAlso: TheraCal PT®Survival rate using TheraCal PT in cariously exposed vital primary molars | Drug | TheraCal PT |
Primary outcome
Survival rate (Absence of spontaneous pain)
Time frame: "3 months"
Binary outcome measured with direct questioning to the patient
Survival rate (Absence of spontaneous pain)
Time frame: "6 months"
Binary outcome measured with direct questioning to the patient
Survival rate (Absence of swelling)
Time frame: "3 months"
Binary outcome measured visually by intraoral/extraoral examination
Survival rate (Absence of swelling)
Time frame: "6 months"
Binary outcome measured visually by intraoral/extraoral examination
2 secondary outcomes
Absence of periapical radiolucency or absence of internal/external root resorption
Time frame: "6 months"
Time lapse till final restoration performed.
Time frame: "During procedure".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing MTA and TheraCal PT in people with Reversible Pulpitis, run by Cairo University.
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 6 inclusion and 9 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 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Reem Mohamed Gaber, B.Sc (01115578688 ext. 0020, reem.gaber@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (Absence of spontaneous pain) (time frame: "3 months"). 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 4 Mar 2022.