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Completed

NCT Number: NCT07569146

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

: 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)

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Key information

Conditions

Implant Therapy

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez canal University

Ismailia, 41522, Egypt

About this study

: 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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.

Treatment and study plan

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.

Immediate dental implants without bone augmentation

Device

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

Primary outcomes

  1. Postoperative Pain (Visual Analog Scale, VAS)

    Time frame: 1, 3, and 7 days postoperatively

    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.

  2. Visual Scale of Edema

    Time frame: 1, 3, and 7 days postoperatively

    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.

  3. Implant Stability (ISQ)

    Time frame: Baseline (immediately after implant placement) and 6 months postoperatively

    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.

  4. Peri-implant Bone Density

    Time frame: Baseline (immediately after implant placement) and 6 months postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Acronym: Mohamed sedky

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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