Dental Caries Extending to PulpNCT03410134
Assessment of Vital Pulp Therapy in Permanent Molars
A study testing NeoMTA in people with Dental Caries Extending to Pulp and Pulp Disease, Dental, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the long term clinical performance of vital pulp therapy of young permanent teeth with irreversible pulpitis Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries Extending to Pulp, Pulp Disease, Dental
- What is being tested?
- NeoMTA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2017to 1 Aug 2023
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients and parents of the patients who accept to participate and sign the informed consent
- Patients who have at least one vital permanent molar teeth with irreversible pulpitis symptoms
- Teeth which can be restorable after the treatment.
- Teeth which has good periodontal health and in the absence of sinus tracts or swelling.
Who cannot join
- Patients and parents of the patients who does not accept to participate and sign the informed consent
- Teeth which have dentoalveolar or extraoral swelling
- Teeth which have periodontal disease, mobility or alveolar bone loss
- Teeth which are not restorable
- Patients who are not cooperative with the treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara, 06100
Zafer C Cehreli, DDS, PhD, +903123052289, zcehreli@gmail.com
Beste Ozgur, DDS, PhD, +903123052280, besteisbitiren@yahoo.com
About this study
Official title: Clinical Evaluation of Vital Pulp Therapy in Young Permanent Molars With Irreversible Pulpitis
The purpose of this study is to evaluate the long term clinical performance of vital pulp therapy of young permanent teeth with irreversible pulpitis
Read the detailed description
Permanent molar teeth meeting the inclusion criteria will be included into the study. Following local anaesthesia and dental dam application, caries excavation will be performed; and after exposure, the pulp will be amputated to the level of the canal orifices (full pulpotomy) using a sterile high-speed round bur under water coolant. After haemostasis is achieved, Mineral trioxide aggregate (MTA) will be gently placed over the pulp to a thickness of 2-3 mm and the tooth will be restored using glass ionomer cement and composite resin. A postoperative periapical radiograph will be taken. Patients will be reviewed at 6., 12., 24. and 36. months for clinical and radiographical success. The data will be analysed statistically using chi square test.
- Being tested
- NeoMTA
- Keywords
- Permanent teeth, Vital pulp therapy, MTA
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoMTADevice
NeoMTA™ Plus® root and pulp treatment material is a powder/gel system with no resin. The components are an extremely fine powder primarily tricalcium and dicalcium silicate plus a water-based gel.
| Study group | Role | What they receive |
|---|---|---|
| NeoMTA | Experimental | Vital pulp therapy with NeoMTA Receives: Device: NeoMTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of vital pulp therapy in permanent teeth with irreversible pulpitis
Long-term success of vital pulp therapy in young permanent teeth with irreversible pulpitis. Evaluation criteria will be;
- spontaneous pain (absent/present);
- tenderness to percussion/palpation (absent/present);
- mobility (no mobility/ 1mm/ 2mm/ 3mm mobility)
- swelling (absent/present);
- fistula (absent/present)
- periapical/interradicular radiolucency (absent/present);
- widened periodontal ligament (absent/present);
- loss of lamina dura (absent/present);
- internal/external root resorption (absent/present).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start1 Nov 2017
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental Caries Extending to PulpStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zafer Cavit Cehreli, DDS, PhD, Hacettepe University
- Investigators
- Zafer C Cehreli, DDS,PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410134
- Sponsor's protocol ID
- Irreversible pulpitis
- Status last verified
- Mar 2021
- First submitted
- 3 Dec 2017
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Asgary S, Eghbal MJ, Ghoddusi J, Yazdani S. One-year results of vital pulp therapy in permanent molars with irreversible pulpitis: an ongoing multicenter, randomized, non-inferiority clinical trial. Clin Oral Investig. 2013 Mar;17(2):431-9. doi: 10.1007/s00784-012-0712-6. Epub 2012 Mar 21.
PubMed 22431145Taha NA, Ahmad MB, Ghanim A. Assessment of Mineral Trioxide Aggregate pulpotomy in mature permanent teeth with carious exposures. Int Endod J. 2017 Feb;50(2):117-125. doi: 10.1111/iej.12605. Epub 2016 Jan 30.
PubMed 26715408Qudeimat MA, Alyahya A, Hasan AA. Mineral trioxide aggregate pulpotomy for permanent molars with clinical signs indicative of irreversible pulpitis: a preliminary study. Int Endod J. 2017 Feb;50(2):126-134. doi: 10.1111/iej.12614. Epub 2016 Feb 22.
PubMed 26841969
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Vital Pulp Therapy in Young Permanent Molars With Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT03410134
- Acronym / sponsor ID
- Irreversible pulpitis
- Keywords
- Permanent teeth, Vital pulp therapy, MTA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 25 Jan 2018 (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 purpose of this study is to evaluate the long term clinical performance of vital pulp therapy of young permanent teeth with irreversible pulpitis
Detailed description
Permanent molar teeth meeting the inclusion criteria will be included into the study. Following local anaesthesia and dental dam application, caries excavation will be performed; and after exposure, the pulp will be amputated to the level of the canal orifices (full pulpotomy) using a sterile high-speed round bur under water coolant. After haemostasis is achieved, Mineral trioxide aggregate (MTA) will be gently placed over the pulp to a thickness of 2-3 mm and the tooth will be restored using glass ionomer cement and composite resin. A postoperative periapical radiograph will be taken. Patients will be reviewed at 6., 12., 24. and 36. months for clinical and radiographical success. The data will be analysed statistically using chi square test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NeoMTA | Experimental | Device: NeoMTAVital pulp therapy with NeoMTA |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients and parents of the patients who accept to participate and sign the informed consent
- Patients who have at least one vital permanent molar teeth with irreversible pulpitis symptoms
- Teeth which can be restorable after the treatment.
- Teeth which has good periodontal health and in the absence of sinus tracts or swelling.
Key exclusion criteria (5 listed)
- Patients and parents of the patients who does not accept to participate and sign the informed consent
- Teeth which have dentoalveolar or extraoral swelling
- Teeth which have periodontal disease, mobility or alveolar bone loss
- Teeth which are not restorable
- Patients who are not cooperative with the treatment
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 |
|---|---|---|
| NeoMTANeoMTA™ Plus® root and pulp treatment material is a powder/gel system with no resin. The components are an extremely fine powder primarily tricalcium and dicalcium silicate plus a water-based gel. | Device | NeoMTA |
Primary outcome
Clinical evaluation of vital pulp therapy in permanent teeth with irreversible pulpitis
Time frame: 3 years
Long-term success of vital pulp therapy in young permanent teeth with irreversible pulpitis. Evaluation criteria will be; 1. spontaneous pain (absent/present); 2. tenderness to percussion/palpation (absent/present); 3. mobility (no mobility/ 1mm/ 2mm/ 3mm mobility) 4. swelling (absent/present); 5. fistula (absent/present) 6. periapical/interradicular radiolucency (absent/present); 7. widened periodontal ligament (absent/present); 8. loss of lamina dura (absent/present); 9. internal/external root resorption (absent/present).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Background: PubMed 22431145Asgary S, Eghbal MJ, Ghoddusi J, Yazdani S. One-year results of vital pulp therapy in permanent molars with irreversible pulpitis: an ongoing multicenter, randomized, non-inferiority clinical trial. Clin Oral Investig. 2013 Mar;17(2):431-9. doi: 10.1007/s00784-012-0712-6. Epub 2012 Mar 21.
- Background: PubMed 26715408Taha NA, Ahmad MB, Ghanim A. Assessment of Mineral Trioxide Aggregate pulpotomy in mature permanent teeth with carious exposures. Int Endod J. 2017 Feb;50(2):117-125. doi: 10.1111/iej.12605. Epub 2016 Jan 30.
- Background: PubMed 26841969Qudeimat MA, Alyahya A, Hasan AA. Mineral trioxide aggregate pulpotomy for permanent molars with clinical signs indicative of irreversible pulpitis: a preliminary study. Int Endod J. 2017 Feb;50(2):126-134. doi: 10.1111/iej.12614. Epub 2016 Feb 22.
- Individual participant dataSharing planned: Undecided
Related trials for Dental Caries Extending to Pulp
Active, not recruiting
Pulp Inflammatory Markers and Outcome of Pulpotomy
Pulpitis in Permanent Teeth, Dental Caries Extending to Pulp
Not yet recruiting
Oxymetazoline Versus Sodium Hypochlorite as Hemostatic Agents in MTA Pulpotomy of Primary Molars
Pulp Disease, Dental, Pulp Therapy in Primary Molars
Not yet recruitingEarly Phase 1
Comparison of Postoperative Pain After Pulpotomy Performed With Versus Without Dental Operating Microscope in Carious Mature Permanent Teeth
Carious Exposure of Pulp
Active, not recruiting
New Vital Pulpotomy Medications in Primary Molars
Carious Exposure of Pulp
RecruitingObservational study
The Effect of Different Risk Factors on the Success Rate of VPT
Dental Caries Extending to Pulp, Pulp Disease, Dental
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.
Zafer C Cehreli, DDS,PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeoMTA in people with Dental Caries Extending to Pulp and Pulp Disease, Dental, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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 15 Mar 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 Turkey (Türkiye). 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 Zafer C Cehreli, Prof (00905353197969, zcehreli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation of vital pulp therapy in permanent teeth with irreversible pulpitis (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03410134, which also lists 3 linked publications.
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 15 Mar 2021.