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
Organization
Ain Shams UniversityProduct
RegenerationIndication
Dental Trauma