Assessment of Vital Pulp Therapy in Permanent Molars

Pulp Disease, Dental Clinical Trial

Official title:

Clinical Evaluation of Vital Pulp Therapy in Young Permanent Molars With Irreversible Pulpitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03410134
• Other study ID #: Irreversible pulpitis
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: August 1, 2023

Study information

• Verified date: March 2021
• Source: Hacettepe University
• Contact: Zafer C Cehreli, Prof
• Phone: 00905353197969
• Email: zcehreli[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries Extending to Pulp
• Dental Pulp Diseases
• Pulp Disease, Dental
• Stomatognathic Diseases

Intervention

Device:
• NeoMTA
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.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	3 years