Assessment of Vital Pulp Therapy in Permanent Molars

Not Applicable

• Conditions: Dental Caries Extending to Pulp; Pulp Disease, Dental
• Interventions: Device: NeoMTA

• Registration Number: NCT03410134
• Lead Sponsor: Hacettepe University

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.

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2017-12-03
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-25
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-12
• Last Update Posted: 2021-03-15
• Primary Completion: 2022-08-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NeoMTA	NeoMTA	Vital pulp therapy with NeoMTA

Primary Outcome Measures

Name	Time	Method
Clinical evaluation of vital pulp therapy in permanent teeth with irreversible pulpitis	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).

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey