Clinical trial

Clinical And Radiographic Evaluation of Nano-Propolis, Nano-Curcumin and MTA as Direct Pulp Capping Agents in Young Permanant Teeth

Name

october 6 university

Description

The aim of the study is to evaluate clinical and radiographic effect of nano propolis and nano curcumin as direct pulp capping agents in young permanent teeth. .

Trial arms

Trial start

2023-01-20

Estimated PCD

2024-09-01

Trial end

2024-12-01

Status

Recruiting

Phase

Early phase I

Treatment

MTA Cement, propolis nano particle, curcumin nanoparticles

MTA or nano propolis or nano curcumin will then be placed over the remaining healthy pulp per the manufacturer's recommendation. The cavities will be lined with glass ionomer cement and a permanent composite restoration will be placed after 6 months. After treatment, a periapical radiograph and CBCT will be immediately taken with ultra-low dose The patients and their parents will be interviewed by telephone on day 1 and day 7 post-surgery about any pain or adverse reactions related to the treatment. Paracetamol will be prescribed if the patients had pain, however, no antibiotic will be used following the surgery. The patients will receive a 3-month follow-up clinical and periapical radiographic examination, together with 6 months clinical and CBCT examinations.

Arms:

MTA, Nano curcumin, Nano propolis

Size

Primary endpoint

Incidence of pain or swelling

1 week ,3 month , 6 month

Eligibility criteria

Inclusion Criteria: * Young permanent teeth with deep carious lesions that led to a caries-exposed pulp after spoon excavation and a diagnosis of reversible pulpitis. * The tooth has a pulp exposure caused by trauma that occurred within 48 h. Exclusion Criteria: * The patient has a history of systemic disease that interferes with pulp healing. * The tooth has clinical signs and symptoms of irreversible pulpitis, e.g., spontaneous throbbing pain, tenderness to percussion, abnormal tooth mobility, swelling, or sinus tract. * Radiographic evidence of internal or external resorption, inter-radicular bone loss, or periapical pathology. * The tooth was non-restorable. During the study, if any symptoms of irreversible pulpitis, apical periodontitis, or infection occurred, the patients received the appropriate treatment following the institute protocol, including regenerative and root canal treatment.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 54, 'type': 'ESTIMATED'}}

Updated at

2024-02-01

1 organization

Organization

Al-Azhar University