Clinical trial NCT03410134: Assessment of Vital Pulp Therapy in Permanent Molars
Official title: Clinical Evaluation of Vital Pulp Therapy in Young Permanent Molars With Irreversible Pulpitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries Extending to Pulp
Pulp Disease, Dental
Keywords: Permanent teeth
Vital pulp therapy
MTA
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Clinical evaluation of vital pulp therapy in permanent teeth with irreversible pulpitis
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Zafer C Cehreli, DDS,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Taha 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.
citation: Qudeimat 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.