Clinical trial

Evaluation of Demineralized Dentin Matrix as a Scaffold for Revascularization in Immature Permanent Incisors: A Randomized Controlled Trial and an In -Vitro Study

Name
AnishamsU ASU
Description
Compare the clinical and radiographic outcomes of demineralized dentin matrix scaffold to blood clot scaffold in immature permanent incisors with non-vital pulps for one year (in vivo). Investigate the effect of demineralized dentin matrix (DDM) on dental pulp stem cells (DPSCs) (in vitro).
Trial arms
Trial start
2022-11-01
Estimated PCD
2024-04-01
Trial end
2024-07-01
Status
Recruiting
Treatment
regeneration technique
clinical procedure of regenerative endodontic as AAE mentioned using different material in each group
Arms:
Control group, positive control, study group DDM
Other names:
regenerative endodontic
Size
30
Primary endpoint
the elimination of symptoms at base line at 0,3 and 6 and 9and 12 month
at 0,3 and 6 and 9and 12 month
Eligibility criteria
Inclusion Criteria : patients clinical examination Must be include the following * Patients aged 7-13years at the time of enrolment. * Provision of informed consent by one parent or legal guardian. * At least the patents have one immature permanent anterior tooth diagnosed with irreversible pulpitis or pulp necrosis with or without periapical lesions. * Restorable teeth ,clinical crown should be enough to use rapper dam Compliant patient/parent. * Patients are not allergic to medicaments and antibiotics necessary to complete the procedure (ASA 1 or 2). * Radiologic evidence of open apices (Teeth are considered immature when a minimum of 0.8 mm apical foramen width is evident) * Exclusion Criteria: * the patients will excluded if one of the following criteria is present in the patients * Teeth with root fractures. * Presence of internal or external root resorptions. * Developmental anomalies of the root. * Presence of periapical radiolucency more than 10 mm. * Tooth with class III mobility.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2023-08-23

1 organization

1 product

1 indication

Indication
Dental Trauma