Caries, DentalNCT03119779
Effect of Pulpotomy Using TheraCal Versus MTA on Survival Rate of Cariously-Exposed Vital Permanent Molars
A study testing MTA-Anglus and TheraCal in people with Caries, Dental, run by Cairo University.
Trial summary
Objective: To assess which is the most efficient pulpotomy medicament on tooth survival in patients with a cariously-exposed vital young permanent molar regarding: absence of postoperative pain, sinus or swelling, internal/ external root resorption, periapical radiolucency), root maturation and decrease chair side… Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Dental
- What is being tested?
- MTA-Anglus and TheraCal
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to 30 Apr 2017
- 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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Restorable permanent molars with deep caries and pain could be relieved with analgesics
Who cannot join
- criteria of exclusion of teeth were:
- pathological mobility, swelling or tenderness to percussion/palpation;
- pathology is shown in the pre-operative radiographic as resorption periradicular or furcation radiolucency, or a widened periodontal ligament space;
- at the operative procedure, hemorrhage control is unachievable
About this study
Official title: The Effect of Pulpotomy (Partial or Complete) Using Resin-Modified Calcium Silicate Versus MTA-Anglus on Survival Rate of Cariously-Exposed Vital Young Permanent Molars:A Randomized Clinical Trial
Objective:
To assess which is the most efficient pulpotomy medicament on tooth survival in patients with a cariously-exposed vital young permanent molar regarding: absence of postoperative pain, sinus or swelling, internal/ external root resorption, periapical radiolucency), root maturation and decrease chair side time of treated patient.
Trial design Randomized Clinical Trial (RCT), double-blinded with parallel group and allocation ratio (1:1), equivalence framework.
Read the detailed description
Preoperative records will be taken (photos, conventional periapical radiographs, and impression to construct acrylic stent to help standardization on follow up apical radiographs). Administration of inferior alveolar nerve block then using rubber dam isolation one of the investigators will remove the caries using large round but under copious amount of coolant and if carious exposure occur, part of the pulp chamber will be removed using sharp spoon excavator. Then the pulp status will be assessed if bleeding is controlled with direct irrigation with distilled water for 2 minutes then next step will be taken but if not continue excavation of the pulp till bleeding is controlled. if bleeding is not controlled after performing complete pulpotomy, tooth will be excluded from the study Then direct application of capping materials (TheraCal or MTA) according to manufacturer instructions, then Riva self-cure glass-ionomer base and composite resin final restoration. One of the investigators will take immediate standardized postoperative periapical radiographs. Follow-up will be for 12 months. Pre-calibrated blinded dentists will assess out comes separately.
- Conditions
- Caries, Dental
- Being tested
- MTA-Anglus, TheraCal
- Keywords
- pulpotomy, deep caries, permanent molars, MTA
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTA-AnglusDrug
Also called MTA-Anglus vital pulp therapy
MTA-Anglus freshly mixed according to manufacturer instructions over glass slap and applied to pulp stump and application of wet cotton for 15 min. till initial setting occur.
TheraCalDrug
Also called TheraCal vital pulp therapy
TheraCal directly applied from the syringe container tip to pulp stump over incremental layers each layer should not exceed 1 mm thickness and each layer will be light cured for 20 sec.
| Study group | Role | What they receive |
|---|---|---|
| TheraCal vital pulp therapy | Experimental | Using rubber dam isolation we will remove the caries using large round but under copious amount of coolant and if carious exposure occur, part of the pulp chamber will be removed using sharp spoon excavator. After complete removal of the caries and control of bleeding, then direct application of incremental layers of TheraCal using the tip of the syringe container of the material and each layer should not exceed 1 mm then light curing each increment. Then Riva self-cure glass-ionomer base and composite resin final restoration. We will take immediate standardized postoperative periapical radiographs. Receives: Drug: TheraCal |
| MTA vital pulp therapy | Active comparator | Using rubber dam isolation we will remove the caries using large round but under copious amount of coolant and if carious exposure occur, part of the pulp chamber will be removed using sharp spoon excavator. After complete removal of the caries and control of bleeding, then direct application of freshly mixed MTA-Anglus on sterile glass slap. MTA application then gentle condensation over wet cotton till MTA thickness is about 2-3 mm thickness and removal of excess material from walls of pulp chamber. Application of wet cotton for 15 min. to achieve initial setting of MTA. Then Riva self-cure glass-ionomer base and composite resin final restoration. We will take immediate standardized postoperative periapical radiographs. Receives: Drug: MTA-Anglus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
absence of any complication or complementary treatment (absence of spontaneous pain or swelling)
Measured: 12 months
Secondary outcomes (3)
periapical radiolucency
presence or absence of periapical radiolucency radiographically
Measured: 12 months
internal/ external root resorption
presence or absence of internal/ external root resorption radiographically
Measured: 12 months
Root maturation
Root maturation assessment radiographically
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 posted19 Apr 2017
- Study startSep 2015
- Primary completion30 Apr 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries, 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Passant Nagy, Cairo University
- Investigators
- Passant Nagi, MSc, Principal investigator, Assisternt lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119779
- Sponsor's protocol ID
- CEBD-CU-2014-09-15
- Status last verified
- Jul 2017
- First submitted
- 11 Apr 2017
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pulpotomy (Partial or Complete) Using Resin-Modified Calcium Silicate Versus MTA-Anglus on Survival Rate of Cariously-Exposed Vital Young Permanent Molars:A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03119779
- Acronym / sponsor ID
- CEBD-CU-2014-09-15
- Conditions
- Caries, Dental
- Keywords
- pulpotomy, deep caries, permanent molars, MTA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 19 Apr 2017 (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.
Objective:
To assess which is the most efficient pulpotomy medicament on tooth survival in patients with a cariously-exposed vital young permanent molar regarding: absence of postoperative pain, sinus or swelling, internal/ external root resorption, periapical radiolucency), root maturation and decrease chair side time of treated patient.
Trial design Randomized Clinical Trial (RCT), double-blinded with parallel group and allocation ratio (1:1), equivalence framework.
Detailed description
Preoperative records will be taken (photos, conventional periapical radiographs, and impression to construct acrylic stent to help standardization on follow up apical radiographs). Administration of inferior alveolar nerve block then using rubber dam isolation one of the investigators will remove the caries using large round but under copious amount of coolant and if carious exposure occur, part of the pulp chamber will be removed using sharp spoon excavator. Then the pulp status will be assessed if bleeding is controlled with direct irrigation with distilled water for 2 minutes then next step will be taken but if not continue excavation of the pulp till bleeding is controlled. if bleeding is not controlled after performing complete pulpotomy, tooth will be excluded from the study Then direct application of capping materials (TheraCal or MTA) according to manufacturer instructions, then Riva self-cure glass-ionomer base and composite resin final restoration. One of the investigators will take immediate standardized postoperative periapical radiographs. Follow-up will be for 12 months. Pre-calibrated blinded dentists will assess out comes separately.
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 |
|---|---|---|
| TheraCal vital pulp therapy | Experimental | Drug: TheraCalUsing rubber dam isolation we will remove the caries using large round but under copious amount of coolant and if carious exposure occur, part of the pulp chamber will be removed using sharp spoon excavator. After complete removal of the caries and control of bleeding, then direct application of incremental layers of TheraCal using the tip of the syringe container of the material and each layer should not exceed 1 mm then light curing each increment. Then Riva self-cure glass-ionomer base and composite resin final restoration. We will take immediate standardized postoperative periapical radiographs. |
| MTA vital pulp therapy | Active comparator | Drug: MTA-AnglusUsing rubber dam isolation we will remove the caries using large round but under copious amount of coolant and if carious exposure occur, part of the pulp chamber will be removed using sharp spoon excavator. After complete removal of the caries and control of bleeding, then direct application of freshly mixed MTA-Anglus on sterile glass slap. MTA application then gentle condensation over wet cotton till MTA thickness is about 2-3 mm thickness and removal of excess material from walls of pulp chamber. Application of wet cotton for 15 min. to achieve initial setting of MTA. Then Riva self-cure glass-ionomer base and composite resin final restoration. We will take immediate standardized postoperative periapical radiographs. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Restorable permanent molars with deep caries and pain could be relieved with analgesics
Key exclusion criteria (4 listed)
- criteria of exclusion of teeth were:
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-AnglusAlso: MTA-Anglus vital pulp therapyMTA-Anglus freshly mixed according to manufacturer instructions over glass slap and applied to pulp stump and application of wet cotton for 15 min. till initial setting occur. | Drug | MTA vital pulp therapy |
| TheraCalAlso: TheraCal vital pulp therapyTheraCal directly applied from the syringe container tip to pulp stump over incremental layers each layer should not exceed 1 mm thickness and each layer will be light cured for 20 sec. | Drug | TheraCal vital pulp therapy |
Primary outcome
Survival rate
Time frame: 12 months
absence of any complication or complementary treatment (absence of spontaneous pain or swelling)
3 secondary outcomes
periapical radiolucency
Time frame: 12 months
internal/ external root resorption
Time frame: 12 months
Root maturation
Time frame: 12 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 25 Jul 2017.
- 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, MSc principal investigator
Assisternt lecturer
Questions about this trial
What is this clinical trial studying?
A study testing MTA-Anglus and TheraCal in people with Caries, Dental, 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 1 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: finished, as of the sponsor's last update on 25 Jul 2017. 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?
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?
Survival rate (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 25 Jul 2017.