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

NCT07569146 | Completed DMC

• 1 other identifier: 969/2025
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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)

Conditions

Implant Therapy

Keywords

deproteinized bovine bone; Implant; clinical stability

Outcome Measures

Primary Outcomes (4)

• Postoperative Pain (Visual Analog Scale, VAS)

  Patients 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.

  1, 3, and 7 days postoperatively

• Visual Scale of Edema

  Facial 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.

  1, 3, and 7 days postoperatively

• Implant Stability (ISQ)

  Clinical 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.

  Baseline (immediately after implant placement) and 6 months postoperatively

• Peri-implant Bone Density

  Bone density around the implants was measured using CBCT radiographs and analyzed with 3D OnDemand software. Measurements were recorded immediately postoperatively and at 6 months.

  Baseline (immediately after implant placement) and 6 months postoperatively

Study Arms (2)

Study group : immediate implants placement with deproteinized bovine bone augmentation

ACTIVE COMPARATOR

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

Device: Immediate dental implants with bone graft augmentation (deproteinized bovine bone)

Control group : Implant implants Placement without bone augmentation

ACTIVE COMPARATOR

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

Device: Immediate dental implants without bone augmentation

Interventions

Immediate dental implants without bone augmentation DEVICE

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

Control group : Implant implants Placement without bone augmentation

Immediate dental implants with bone graft augmentation (deproteinized bovine bone) DEVICE

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

Study group : immediate implants placement with deproteinized bovine bone augmentation

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Medically compromised patient (uncontrolled diabetes, radiotherapy, chemotherapy and hemophilia.
• Patient with bad oral habit as bruxism, heavy smoking over 10 cigarettes a day.
• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez canal University

Ismailia, 41522, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: May 6, 2026
• Study Start: January 1, 2025
• Primary Completion: December 5, 2025
• Study Completion: January 8, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

EG (1)