Clinical trial

PRGF VS CGF in Management of Labial Dehiscence Around Immediate Implants (Comparative Study) {PRGF= Plasma Rich in Growth Factors } {CGF=Concentrated Growth Factor}

Name
HFMHAElkhe0001
Description
The goal of this clinial trial is to detect Which one of two different platelet concentrate bio-membrane (first or third generation) is better in terms of marginal bone level and bone density around immediate implants in esthetic zone using Cone beam computerized tomography The plasma rich in growth factor or concentrated growth factor? 20 patients with nonrestorable maxillary tooth in the esthetic zone, Subjects will be enrolled The study will use simple randomization to allocate patients into 2 groups, each group will be included 10 patients: Group A: (concentrated growth factor group) ten patients indicated for immediate implant in the maxillary anterior region (class II socket), will be a candidate for immediate implant placement with CGF combined with xenogeneic bone graft Group B: (platelet-rich in growth factor group) Ten patients who indicated immediate implant in the maxillary anterior region (class I or class II socket), will be a candidate for immediate implant placement with PRGF combined with xenogeneic bone graft.
Trial arms
Trial start
2022-02-01
Estimated PCD
2023-07-30
Trial end
2023-08-30
Status
Active (not recruiting)
Treatment
Drug: Growth Factors (CGF)
Application of biological membrane of Concentrated growth factor (CGF) over bone grafting and implant
Arms:
group A (Concentrated Growth Factor) CGF
Other names:
Concentrated growth factor
Drug: Growth Factors (PRGF)
Application of biological membrane of Plasma rich in growth factors combined with Xenogeneic bone grafting material around immediate implant
Arms:
group B (Plasma Rich in Growth Factor) PRGF
Other names:
Plasma rich in growth factors
Surgery: Dental Implant surgery
Immediate implant following extraction
Arms:
group A (Concentrated Growth Factor) CGF, group B (Plasma Rich in Growth Factor) PRGF
Tooth extraction
A Traumatic tooth extraction
Arms:
group A (Concentrated Growth Factor) CGF, group B (Plasma Rich in Growth Factor) PRGF
Xenogenic bone grafting
Application of bovine bone grafting over area of dehiscence around immediate implant
Arms:
group A (Concentrated Growth Factor) CGF
Size
20
Primary endpoint
Bone density
9 months
Marginal bone level.
9 months
Eligibility criteria
Inclusion Criteria: 1. Selected patients of both sexes are 20-40 years old. 2. Patients are systemically healthy based on questionnaire dental modification of Cornell index. 3. Gingival health according to the new classification system (2017) 4. The recipient site of the implant is free from any pathological conditions. 5. Class II extraction socket according to Chang's classification system 6. Adequate interocclusal space to accommodate the available restorative components. 7. Adequate native/apical bone to achieve primary implant stability. Exclusion Criteria: 1. Pregnant female. 2. Para-functional habits such as bruxism and clenching Patients suffering from periodontitis. 3. Smokers.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will use simple randomization to allocate patients into 2 groups, each group will be included 10 patients.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}
Updated at
2023-02-21

1 organization

2 products

1 indication

Organization
Minia University