Pulp Exposure, DentalPhase 2/3NCT03838068
Pulpotomy Technique Preserving Vitality of Traumatized Anterior Permanent Immature Teeth
A Phase 2/3 study testing Biodentine, mineral trioxide aggregate and cervical pulpotomy in people with Pulp Exposure, Dental, run by Gihan M Abuelniel ,PhD at 1 site in Egypt.
Trial summary
Aim of the study: To compare the clinical and radiographic outcomes of mineral trioxide aggregate (MTA) and Biodentine as vital pulp therapy materials (pulpotomy) preserving the vitality of traumatized immature anterior permanent teeth. Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Exposure, Dental
- What is being tested?
- Biodentine, mineral trioxide aggregate and cervical pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jan 2017to 15 Aug 2019
- Phase
- Phase 2/3
- 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 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The patient age range 7.5-9 years.
- Noncontributory medical history
- Unilateral/ and or bilateral central incisors tooth with complicated trauma (exposure size ≥ 1mm)
- The tooth should give positive response to cold testing
- Clinical diagnosis of reversible pulpitis without periapical rarefaction
- The tooth is restorable, mobility was within normal limits
- No signs of pulpal necrosis including sinus tract or swelling
Who cannot join
- Teeth with mature roots
- Signs and symptoms of irreversible pulpitis
- Non-restorable teeth
- Negative response to cold testing, the presence of sinus tract or swelling
- No pulp exposure
- Bleeding could not be controlled after full pulpotomy in 6 minutes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Pulpotomy Technique for Preserving Vitality of Traumatized Anterior Permanent Immature Teeth: A Randomized Clinical Trial
Aim of the study: To compare the clinical and radiographic outcomes of mineral trioxide aggregate (MTA) and Biodentine as vital pulp therapy materials (pulpotomy) preserving the vitality of traumatized immature anterior permanent teeth.
Materials and Methods: fifty vital traumatized immature anterior permanent teeth exposed with symptomatic /asymptomatic pulpitis were included in the study according to inclusion criteria and were equally divided in two groups. Included teeth were randomly assigned to either a control group (MTA 25 teeth) or a test group (Biodentine 25 teeth). After conducting pulpotomy and covering pulp stumps with the MTA and Biodentine, treated teeth received permanent restorations. Blinded clinical and radiographic evaluations were performed at different time intervals (base line immediate postoperative, 6, 12 and 18 months) according to clinical and radiographic criteria of success. Data were recorded and analyzed.
Read the detailed description
Informed consent was obtained from all patients prior to treatment, and patients were offered Root canal treatment in case of treatment failure.
Thirty-three patients who were referred to the postgraduate pediatric dentistry department clinic for the management of their traumatized permanent incisors teeth were assessed. Only Patients who had a traumatic incisor tooth with a vital pulp (detected by clinical signs/symptoms) were included.
Incisors were assigned randomly in the two groups. The MTA group was considered the control group while the biodentine was the test group.
All patients who were clinically eligible for enrollment in the study went through screening pre-operative digital periapical radiographic examination to assess the degree of root development/ formation and any dental infections or anomalies that could interfere with the planned treatment.
The main investigator performed all pulpotomies. Local anesthesia was administrated followed by rubber dam isolation, the coronal pulp tissue was excised to the level of the orifice using a diamond bur with water cooling. Hemostasis was achieved by gentle placement of a saline-moistened cotton pellet over amputated pulps for 5-10 min. Pulp stumps were covered with:
In the first group (control group) white mineral trioxide aggregate (MTA) ProRoot® MTA (Dentsply/ Johnson City,TN,USA) was used as the reference material for comparison and was prepared according to the manufacturer's instructions. A 3-mm-thick layer of MTA was placed over the amputated pulps and was gently adapted to the dentinal walls using a wet cotton pellet deep onto the radicular pulp. A self-cure glass ionomer (GC; GC Corporation, Tokyo, Japan) was placed over the pulpotomy agent before final restoration of composite resin (ClearfilTM, Kuraray, New York, USA) was done.
In the second group Calcium silicate-based BiodentineTM (Septodont Ltd., Saint Maur des Fausse´s, France) was mixed according to the manufacturer's instructions, pulpotomy was performed, radicular pulp was covered, and teeth received self-cure glass ionomer prior to final restoration with the same technique as in the first group.
- Conditions
- Pulp Exposure, Dental
- Being tested
- Biodentine, mineral trioxide aggregate, cervical pulpotomy, Local Anesthetics Procaine
- Keywords
- trauma, vital immature, MTA, Biodentine
- Medical subject headings
- Dental Pulp Exposure, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodentineBiological
Also called Calcium silicate-based
Biodentine is considered a calcium silicate cement
mineral trioxide aggregateBiological
Also called MTA
calcium based silicate cement
cervical pulpotomyProcedure or surgery
coronal pulp tissue was removed till the orifice
Local Anesthetics ProcaineDrug
Also called artinibsa
40 mg/0.01 mg/ml contains sodium metabisulfite and sodium and articaine as an active substance
| Study group | Role | What they receive |
|---|---|---|
| Mineral trioxide aggegate | Active comparator | white mineral trioxide aggregate (MTA) calcium silicate-based cement Receives: Biological: mineral trioxide aggregate; Procedure: cervical pulpotomy; Drug: Local Anesthetics Procaine |
| Biodentine | Experimental | calcium silicate-based cement that consists of tricalcium silicate, dicalcium silicate, calcium carbonate, calcium oxide, zirconium oxide, and CH. Receives: Biological: Biodentine; Procedure: cervical pulpotomy; Drug: Local Anesthetics Procaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of pain,sensitivity to percussion/ palpation
by asking the patient( questionnaire) (Binary measure) ( Yes or No) where Yes indicates failure of the treatment
Measured: 18 months
Swelling or sinus tract
by visual examination (binary measure)( Yes or No) where Yes indicates clinical failure of the treatment
Measured: 18 months
presence of mobility
by the back of the mirror( Binary measure) (Yes or No) where Yes indicates clinical failure of the treatment.
Measured: 18 months
Secondary outcomes (2)
Stage of root development
by radiographic parallel technique ( four root development stages are assessed E, F,G and H) where E is the worse and H is the best stage.
Measured: 18 months
Presence of radiolucency
by radiographic parallel technique (Binary measure) (Yes or No) where Yes indicates radiographic failure of the treatment.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start18 Jan 2017
- Primary completion30 Dec 2018
- Study completion15 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp Exposure, DentalStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Access cavity in traumatized central incisors will be assigned into experimental or control group using simple randomization 1:1 by the help of the computer software(random.org).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gihan M Abuelniel ,PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Gihan M Abuelniel ,PhD, Cairo University
- Investigators
- Gihan M Abuelniel, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838068
- Sponsor's protocol ID
- 19118
- Status last verified
- Dec 2019
- First submitted
- 6 Feb 2019
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Pulpotomy Technique for Preserving Vitality of Traumatized Anterior Permanent Immature Teeth: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03838068
- Acronym / sponsor ID
- 19118
- Conditions
- Pulp Exposure, Dental
- Keywords
- trauma, vital immature, MTA, Biodentine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Gihan M Abuelniel ,PhDUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 12 Feb 2019 (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.
Aim of the study: To compare the clinical and radiographic outcomes of mineral trioxide aggregate (MTA) and Biodentine as vital pulp therapy materials (pulpotomy) preserving the vitality of traumatized immature anterior permanent teeth.
Materials and Methods: fifty vital traumatized immature anterior permanent teeth exposed with symptomatic /asymptomatic pulpitis were included in the study according to inclusion criteria and were equally divided in two groups. Included teeth were randomly assigned to either a control group (MTA 25 teeth) or a test group (Biodentine 25 teeth). After conducting pulpotomy and covering pulp stumps with the MTA and Biodentine, treated teeth received permanent restorations. Blinded clinical and radiographic evaluations were performed at different time intervals (base line immediate postoperative, 6, 12 and 18 months) according to clinical and radiographic criteria of success. Data were recorded and analyzed.
Detailed description
Informed consent was obtained from all patients prior to treatment, and patients were offered Root canal treatment in case of treatment failure.
Thirty-three patients who were referred to the postgraduate pediatric dentistry department clinic for the management of their traumatized permanent incisors teeth were assessed. Only Patients who had a traumatic incisor tooth with a vital pulp (detected by clinical signs/symptoms) were included.
Incisors were assigned randomly in the two groups. The MTA group was considered the control group while the biodentine was the test group.
All patients who were clinically eligible for enrollment in the study went through screening pre-operative digital periapical radiographic examination to assess the degree of root development/ formation and any dental infections or anomalies that could interfere with the planned treatment.
The main investigator performed all pulpotomies. Local anesthesia was administrated followed by rubber dam isolation, the coronal pulp tissue was excised to the level of the orifice using a diamond bur with water cooling. Hemostasis was achieved by gentle placement of a saline-moistened cotton pellet over amputated pulps for 5-10 min. Pulp stumps were covered with:
In the first group (control group) white mineral trioxide aggregate (MTA) ProRoot® MTA (Dentsply/ Johnson City,TN,USA) was used as the reference material for comparison and was prepared according to the manufacturer's instructions. A 3-mm-thick layer of MTA was placed over the amputated pulps and was gently adapted to the dentinal walls using a wet cotton pellet deep onto the radicular pulp. A self-cure glass ionomer (GC; GC Corporation, Tokyo, Japan) was placed over the pulpotomy agent before final restoration of composite resin (ClearfilTM, Kuraray, New York, USA) was done.
In the second group Calcium silicate-based BiodentineTM (Septodont Ltd., Saint Maur des Fausse´s, France) was mixed according to the manufacturer's instructions, pulpotomy was performed, radicular pulp was covered, and teeth received self-cure glass ionomer prior to final restoration with the same technique as in the first group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Access cavity in traumatized central incisors will be assigned into experimental or control group using simple randomization 1:1 by the help of the computer software(random.org).
| Arm | Type | Receives |
|---|---|---|
| Mineral trioxide aggegate | Active comparator | Biological: mineral trioxide aggregate, Procedure: cervical pulpotomy, Drug: Local Anesthetics Procainewhite mineral trioxide aggregate (MTA) calcium silicate-based cement |
| Biodentine | Experimental | Biological: Biodentine, Procedure: cervical pulpotomy, Drug: Local Anesthetics Procainecalcium silicate-based cement that consists of tricalcium silicate, dicalcium silicate, calcium carbonate, calcium oxide, zirconium oxide, and CH. |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- The patient age range 7.5-9 years.
- Noncontributory medical history
- Unilateral/ and or bilateral central incisors tooth with complicated trauma (exposure size ≥ 1mm)
- The tooth should give positive response to cold testing
- Clinical diagnosis of reversible pulpitis without periapical rarefaction
Key exclusion criteria (6 listed)
- Teeth with mature roots
- Signs and symptoms of irreversible pulpitis
- Non-restorable teeth
- Negative response to cold testing, the presence of sinus tract or swelling
- No pulp exposure
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 |
|---|---|---|
| BiodentineAlso: Calcium silicate-basedBiodentine is considered a calcium silicate cement | Biological | Biodentine |
| mineral trioxide aggregateAlso: MTAcalcium based silicate cement | Biological | Mineral trioxide aggegate |
| cervical pulpotomycoronal pulp tissue was removed till the orifice | Procedure or surgery | Biodentine, Mineral trioxide aggegate |
| Local Anesthetics ProcaineAlso: artinibsa40 mg/0.01 mg/ml contains sodium metabisulfite and sodium and articaine as an active substance | Drug | Biodentine, Mineral trioxide aggegate |
Primary outcome
presence of pain,sensitivity to percussion/ palpation
Time frame: 18 months
by asking the patient( questionnaire) (Binary measure) ( Yes or No) where Yes indicates failure of the treatment
Swelling or sinus tract
Time frame: 18 months
by visual examination (binary measure)( Yes or No) where Yes indicates clinical failure of the treatment
presence of mobility
Time frame: 18 months
by the back of the mirror( Binary measure) (Yes or No) where Yes indicates clinical failure of the treatment.
2 secondary outcomes
Stage of root development
Time frame: 18 months
Presence of radiolucency
Time frame: 18 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 27 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Pulp Exposure, Dental
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Recruiting
Pomegranate Peel Extract for Primary Molar Pulpotomy
Pulpitis Reversible, Pulp Exposure, Dental
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Pulpotomy in Hypominerlized Permanent Molars.
Molar Hypomineralization
Active, not recruiting
Direct Pulp Capping Compared to Partial Pulpotomy in Carious Pulp Exposures
Deep Caries
Not yet recruiting
Oxymetazoline Versus Sodium Hypochlorite as Hemostatic Agents in MTA Pulpotomy of Primary Molars
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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.
Gihan M Abuelniel principal investigator
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 2/3 study testing Biodentine, mineral trioxide aggregate and cervical pulpotomy in people with Pulp Exposure, Dental, run by Gihan M Abuelniel ,PhD 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 7 inclusion and 6 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 27 Dec 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
presence of pain,sensitivity to percussion/ palpation (time frame: 18 months). The study lists 3 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 27 Dec 2019.