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Assessment of Deproteinized Bovine Bone for Immediate Implants Placement in Maxillary Esthetic Zone.

Assessment of Deproteinized Bovine Bone for Immediate Implants Placement in Maxillary Esthetic Zone: A Randomized Clinical Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07569146
Acronym
Mohamed sedky
Enrollment
16
Registered
2026-05-06
Start date
2025-01-01
Completion date
2026-01-08
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implant Therapy

Keywords

deproteinized bovine bone, Implant, clinical stability

Brief summary

: Many of studies have been performed to improve osseointegration and bone density around implants by modifying the implant by adding bone graft or substitute material that increase success of implant. Aim: The aim of this study is to evaluate clinically the efficacy of deproteinized bovine bone in maxillary Esthetic zone to promote bone formation and improve outcomes in immediate implant cases. Methodology: 16 immediate implants will be placed in maxillary esthetic zone. That study will be Conducted on 16 hopeless teeth divided equally and randomly into two groups Randomization will be done using www.randomizer.org ., Group 1: 8 hopeless teeth will be replaced by immediate dental implants represent the (control group) where the implants will be placed without bone graft, Group 2: 8 hopeless teeth will be replaced by immediate dental implants represent the (study group) where the implants will be placed with deproteinized bovine bone graft. The implant stability will be assessed clinically using (Ostell) immediate postoperative and after 6 months and Postoperative pain using visual analogue scale (VAS)

Detailed description

: Many of studies have been performed to improve osseointegration and bone density around implants by modifying the implant by adding bone graft or substitute material that increase success of implant. Aim: The aim of this study is to evaluate clinically the efficacy of deproteinized bovine bone in maxillary Esthetic zone to promote bone formation and improve outcomes in immediate implant cases. Methodology: 16 immediate implants will be placed in maxillary esthetic zone. That study will be Conducted on 16 hopeless teeth divided equally and randomly into two groups Randomization will be done using www.randomizer.org ., Group 1: 8 hopeless teeth will be replaced by immediate dental implants represent the (control group) where the implants will be placed without bone graft, Group 2: 8 hopeless teeth will be replaced by immediate dental implants represent the (study group) where the implants will be placed with deproteinized bovine bone graft. The implant stability will be assessed clinically using (Ostell) immediate postoperative and after 6 months and Postoperative pain using visual analogue scale (VAS). Pre and Post Operative CBCT Will be taken. Bone density will be assessed Using 3D onDemand Softwear.

Interventions

DEVICEImmediate dental implants with bone graft augmentation (deproteinized bovine bone)

8 hopeless teeth was replaced by immediate dental implants with deproteinized bovine bone graft.

DEVICEImmediate dental implants without bone augmentation

8 hopeless teeth was replaced by immediate dental implants without bone augmentation

Sponsors

Suez Canal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

This study will be conducted on 16 hopeless teeth, divided into 2 group Group 1 (Control Group): 8 hopeless teeth will be replaced by immediate dental implants where the implants will be placed without bone graft . Group 2 (Study Group): 8 hopeless teeth will be replaced by immediate dental implants were the implants will be placed with deproteinized bovine bone graft.

Eligibility

Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

1. Patients with hopeless teeth at maxillary esthetic zone. 2. Both genders. 3. Middle age adults (from 20 years to 55 years). 4. The tooth to be extracted had little to no loss of periodontal bone. 5. The tooth where endodontic involvement, root fracture, root resorption, periapical pathology, root perforation

Exclusion criteria

* 1-Medically compromised patient (uncontrolled diabetes, radiotherapy, chemotherapy and hemophilia. 2-Patient with bad oral habit as bruxism, heavy smoking over 10 cigarettes a day. 3-Patient with bad oral hygiene. 4-Patient with generalized gingival diseases. 5-Patient with generalized periodontal diseases \[with sever vertical or horizontal bone loss\] 6-Teeth with periapical or lateral acute infection or lesions.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain (Visual Analog Scale, VAS)1, 3, and 7 days postoperativelyPatients reported the degree of pain using a 10-cm visual analog scale (VAS), where 0 = no pain and 10 = worst possible pain. Pain was assessed at 1, 3, and 7 days postoperatively.
Visual Scale of Edema1, 3, and 7 days postoperativelyFacial edema was assessed using a visual grading scale: No edema, Low-grade, Intermediate-grade, and High-grade, based on visual inspection and palpation. Edema was evaluated at 1, 3, and 7 days postoperatively.
Implant Stability (ISQ)Baseline (immediately after implant placement) and 6 months postoperativelyClinical stability of dental implants was assessed using the Osstell device. The implant stability quotient (ISQ) was measured immediately after implant placement and at 6 months postoperatively. ISQ scores range from 1-100, with scores ≥70 indicating high stability, 60-69 medium stability, and \<60 low stability.
Peri-implant Bone DensityBaseline (immediately after implant placement) and 6 months postoperativelyBone density around the implants was measured using CBCT radiographs and analyzed with 3D OnDemand software. Measurements were recorded immediately postoperatively and at 6 months.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026