Carious Exposure of PulpPhase 1/2NCT03838094
Evaluation of MTA Versus Biodentine as Pulpotomy Agents in Immature First Permanent Molars
A Phase 1/2 study testing Biodentine and MTA in people with Carious Exposure of Pulp, run by Gihan M Abuelniel ,PhD.
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) of cariously exposed vital immature mandibular first permanent molars. Read more about this study
- Who is it for?
- Ages 7 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Carious Exposure of Pulp
- What is being tested?
- Biodentine and MTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Sep 2018
- 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 7 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Bilaterally Symptomatic ⁄ asymptomatic vital immature mandibular first permanent molars (with clinical carious exposure of the pulp and presence of bleeding upon exposure)
- Patients with an age range from 7-8 years.
- Absence of sinus tract, soft tissue swelling.
Who cannot join
- • Molars were excluded if non-restorable.
- excessive mobility (more than 1 mm horizontally).
- Radiographic evidence of peri- and ⁄or inter-radicular lesions, internal⁄ external root resorption, pulp⁄ canal calcifications.
About this study
Official title: Clinical and Radiographic Evaluation of MTA Versus Biodentine as Pulpotomy Agents in Immature First Permanent Molars: 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) of cariously exposed vital immature mandibular first permanent molars.
Materials and Methods: sixty immature first mandibular permanent molars cariously exposed with symptomatic /asymptomatic pulpitis were included in the study according to inclusion criteria and were equally divided in two groups. Following split-mouth design molars were randomly assigned to either a control group (MTA 30 molars) or a test group (Biodentine 30 molars). After conducting pulpotomy and covering pulp stumps with the MTA and Biodentine, treated molars 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 analysed.
Read the detailed description
Diagnosis:
- Full history data will be collected, including personal, medical and previous dental data
- Clinical examination using mirror and probe to assess the inclusion criteria.
- Radiographic examination using preoperative digital periapical radiograph to assess the inclusion criteria.
- Preoperative photograph will be taken.
Operative procedure:
Experimental group:
- Injection of local anesthesia and rubber dam isolation.
- caries and roof of the pulp chamber will be removed by a fissure diamond bur (Diatech, Heerbrug, Switzerland) and high-speed handpiece with coolant.
- The pulps will be amputated to the orifice level using a long-shank diamond round bur.
- Haemostasis will be achieved by gentle placement of a saline-moistened cotton pellet over amputated pulps for 5-10 min.
- Calcium silicate-based BiodentineTM (Septodont Ltd., Saint Maur des Fausse´s, France) will be mixed according to the manufacturer's instructions, radicular pulp will be covered by the material using a wet cotton pellet.
- A self-cure glass ionomer (GC; GC Corporation, Tokyo, Japan) will be placed over the pulpotomy agent as a final restoration.
- Immediate post-operative radiograph and photograph will be taken.
Control group:
The same procedures will be carried out as the experimental group, but the pulp stumps will be covered with fast-setting mineral trioxide aggregate (MTA) ENDOCEM MTA (Maruchi, Wonju, Korea) and will be prepared according to the manufacturer's instructions. A 3-mm-thick layer of MTA will be placed over the amputated pulps and will be gently adapted to the dentinal walls using a wet cotton pellet. A self-cure glass ionomer (GC; GC Corporation, Tokyo, Japan) will be placed over the pulpotomy agent as a final restoration.
Postoperative care:
Instructions to avoid lip and cheek biting in addition to oral hygiene measures.
Follow up:
Assess the outcomes clinically and radiographically at (baseline, 6, 12 and 18 months).
- Conditions
- Carious Exposure of Pulp
- Being tested
- Biodentine, MTA
- Keywords
- pulp exposure, vital immature, MTA, Biodentine
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 biomaterial
it is a dentin substitute, a new biologically active material facilitates its penetration through opened dentinal tubules to crystallize interlocking with dentin and provide mechanical properties.
MTABiological
Also called mineral trioxide aggregate
MTA is a powder that consists of fine hydrophilic particles that set in the presence of moisture. MTA consists of tricalcium silicate, tricalcium aluminate, tricalcium oxide and silicate oxide. MTA was considered a remarkable biocompatible material with various clinical applications that include surgical and non-surgical applications such as pulp capping
| Study group | Role | What they receive |
|---|---|---|
| MTA Group | Active comparator | pulpotomy technique using fast-setting mineral trioxide aggregate (MTA) to be considered the control group for vital pulp therapy and was placed over the amputated pulps for 18 months. This group will be compared with the Biodentine group as the intervention group Receives: Biological: MTA |
| Biodentine group | Experimental | 3 mm- thick Biodentine covered radicular pulp to allow pulp regeneration Receives: Biological: Biodentine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain, sensitivity to percussion⁄ palpation
by asking the patient( binary measure)Yes or No, where Yes indicates presence of pain that shows clinical failure
Measured: 18 months
Swelling or sinus tract
by visual examination( Binary measure) (Yes or No) where No indicates success of the treatment
Measured: 18 months
tooth mobility
by back of the mirror( Binary measure) (Yes or No) where No mobility indicates success of the treatment
Measured: 18 months
Secondary outcomes (4)
root formation/development stage
by radiographic parallel technique to measure the maturity scores used during the radiographic assessment of root development are F, G and H (where F is the worse and H is the best stage)
Measured: 18 months
Crown: Root ratio
by radiographic parallel technique ( the ratio 2:1 or more than 2:1) the ratio more than 2:1 is the best
Measured: 18 months
Apical closure
by radiographic parallel technique( the apex is blunder apex ,partially open, or constricted) blunder apex is the worse and constricted apex is the best.
Measured: 18 months
presence of radiolucency
by radiographic parallel technique( binary measure)( yes or No) if radiolucency is detected this indicates failure of the treatment
Measured: 18 month
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 startFeb 2016
- Primary completionAug 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carious Exposure of PulpStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 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, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838094
- Sponsor's protocol ID
- 19119
- Status last verified
- Feb 2019
- First submitted
- 6 Feb 2019
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only final results
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of MTA Versus Biodentine as Pulpotomy Agents in Immature First Permanent Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03838094
- Acronym / sponsor ID
- 19119
- Conditions
- Carious Exposure of Pulp
- Keywords
- pulp exposure, vital immature, MTA, Biodentine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gihan M Abuelniel ,PhDUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- Feb 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Sep 2018 (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) of cariously exposed vital immature mandibular first permanent molars.
Materials and Methods: sixty immature first mandibular permanent molars cariously exposed with symptomatic /asymptomatic pulpitis were included in the study according to inclusion criteria and were equally divided in two groups. Following split-mouth design molars were randomly assigned to either a control group (MTA 30 molars) or a test group (Biodentine 30 molars). After conducting pulpotomy and covering pulp stumps with the MTA and Biodentine, treated molars 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 analysed.
Detailed description
Diagnosis:
- Full history data will be collected, including personal, medical and previous dental data
- Clinical examination using mirror and probe to assess the inclusion criteria.
- Radiographic examination using preoperative digital periapical radiograph to assess the inclusion criteria.
- Preoperative photograph will be taken.
Operative procedure:
Experimental group:
- Injection of local anesthesia and rubber dam isolation.
- caries and roof of the pulp chamber will be removed by a fissure diamond bur (Diatech, Heerbrug, Switzerland) and high-speed handpiece with coolant.
- The pulps will be amputated to the orifice level using a long-shank diamond round bur.
- Haemostasis will be achieved by gentle placement of a saline-moistened cotton pellet over amputated pulps for 5-10 min.
- Calcium silicate-based BiodentineTM (Septodont Ltd., Saint Maur des Fausse´s, France) will be mixed according to the manufacturer's instructions, radicular pulp will be covered by the material using a wet cotton pellet.
- A self-cure glass ionomer (GC; GC Corporation, Tokyo, Japan) will be placed over the pulpotomy agent as a final restoration.
- Immediate post-operative radiograph and photograph will be taken.
Control group:
The same procedures will be carried out as the experimental group, but the pulp stumps will be covered with fast-setting mineral trioxide aggregate (MTA) ENDOCEM MTA (Maruchi, Wonju, Korea) and will be prepared according to the manufacturer's instructions. A 3-mm-thick layer of MTA will be placed over the amputated pulps and will be gently adapted to the dentinal walls using a wet cotton pellet. A self-cure glass ionomer (GC; GC Corporation, Tokyo, Japan) will be placed over the pulpotomy agent as a final restoration.
Postoperative care:
Instructions to avoid lip and cheek biting in addition to oral hygiene measures.
Follow up:
Assess the outcomes clinically and radiographically at (baseline, 6, 12 and 18 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTA Group | Active comparator | Biological: MTApulpotomy technique using fast-setting mineral trioxide aggregate (MTA) to be considered the control group for vital pulp therapy and was placed over the amputated pulps for 18 months. This group will be compared with the Biodentine group as the intervention group |
| Biodentine group | Experimental | Biological: Biodentine3 mm- thick Biodentine covered radicular pulp to allow pulp regeneration |
Who may qualify
- Ages
- 7 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Bilaterally Symptomatic ⁄ asymptomatic vital immature mandibular first permanent molars (with clinical carious exposure of the pulp and presence of bleeding upon exposure)
Key exclusion criteria (3 listed)
- • Molars were excluded if non-restorable.
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-based biomaterialit is a dentin substitute, a new biologically active material facilitates its penetration through opened dentinal tubules to crystallize interlocking with dentin and provide mechanical properties. | Biological | Biodentine group |
| MTAAlso: mineral trioxide aggregateMTA is a powder that consists of fine hydrophilic particles that set in the presence of moisture. MTA consists of tricalcium silicate, tricalcium aluminate, tricalcium oxide and silicate oxide. MTA was considered a remarkable biocompatible material with various clinical applications that include surgical and non-surgical applications such as pulp capping | Biological | MTA Group |
Primary outcome
pain, sensitivity to percussion⁄ palpation
Time frame: 18 months
by asking the patient( binary measure)Yes or No, where Yes indicates presence of pain that shows clinical failure
Swelling or sinus tract
Time frame: 18 months
by visual examination( Binary measure) (Yes or No) where No indicates success of the treatment
tooth mobility
Time frame: 18 months
by back of the mirror( Binary measure) (Yes or No) where No mobility indicates success of the treatment
4 secondary outcomes
root formation/development stage
Time frame: 18 months
Crown: Root ratio
Time frame: 18 months
Apical closure
Time frame: 18 months
presence of radiolucency
Time frame: 18 month
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 12 Feb 2019.
- Individual participant dataSharing planned: No. only final results
Related trials for Carious Exposure of Pulp
Active, not recruiting
Laser Assisted Pulpotomy Versus MTA Pulpotomy in Permanent Teeth With Irreversible Pulpitis
Irreversible Pulpitis (Toothache)
Active, not recruiting
Pulpotomy in Hypominerlized Permanent Molars.
Molar Hypomineralization
Active, not recruiting
Pulp Inflammatory Markers and Outcome of Pulpotomy
Pulpitis in Permanent Teeth, Dental Caries Extending to Pulp
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
Pulp Disease, Dental, Pulp Therapy in Primary Molars
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, PhD principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Biodentine and MTA in people with Carious Exposure of Pulp, run by Gihan M Abuelniel ,PhD.
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 3 inclusion and 3 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 12 Feb 2019. 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.
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?
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?
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 12 Feb 2019.