Immediate Implant Clinical Trial
Official title:
Evaluation of Autogenous Demineralized Tooth Graft Versus Autogenous Bone Graft During Immediate Implant Placement in the Esthetic Zone. (Randomized Controlled Clinical Trial).
To compare the use of demineralized autogenous tooth graft versus autogenous bone graft, in the jumping gap in immediate implant placement with immediate loading.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | August 1, 2023 |
Est. primary completion date | August 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Patients in need of extraction of a single, un-restorable tooth in the esthetic zone (Maxillary anteriors and premolars). Only one implant per patient. An intact buccal plate of bone, or minimally affected. Jumping gap = 2mm . Age 18-60. Medically free patients. Exclusion Criteria: - Restorable teeth. Teeth with severely damaged or no remaining buccal plate. Acute infection in the implant site. Patients with an insufficient bone to obtain primary stability. Patients in need of sinus bone grafting. A systemic condition that affects bone healing (e.g., diabetes mellitus or bone disease). Smokers. Poor oral hygiene. Patient with a physical disability that hinders the upkeep of good oral hygiene measures. Any general contraindication to oral surgery. Participants suffering from diseases that may affect bone or soft tissue healing. A participant who had radiotherapy or chemotherapy. Psychiatric patient, or with a learning disability, or unable to give consent. Pregnant and nursing women |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry Ciaro University | Cairo | El Manial |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Marginal bone level | Marginal bone level: The bone level will be measured from the implant shoulder to the first bone-implant contact, from all 4 surfaces (mesial, distal, buccal, and lingual/palatal), measured by CBCT scans. | 9 months | |
Secondary | post operative pain | Visual analog scale (0-10) | 2 weeks | |
Secondary | Implant sucess | Based on the criteria of Albrektsson, Zarb, Worthington, and Eriksson(1986) and of Buser, Weber and Lang(1990). The following are the criteria for implant success: the absence of mobility, the absence of acute or chronic peri-implant infection, the absence of radiolucency around the implant, without pocket probing depth (PPD) ? 5 mm, and without vertical bone loss ? 1.5 mm in the first year. The cases will be defined as a failure if they can't reach any one of the success criteria | 12 months | |
Secondary | Pink esthetic score | The PES includes seven variables: the mesial papilla, distal papilla, midfacial level, midfacial contour, alveolar process deficiency, soft tissue color, and soft tissue texture. Each variable was evaluated with a 0-1-2 score, with 2 being the best and 0 being the worst. Thus, the highest total score was 14. The mesial and distal papillae were assessed for completeness. All other variables were evaluated by comparison with the contralateral tooth. The threshold of an acceptable PES was 8. Scores of 12 or more indicated a nearly perfect outcome | 12 months |
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