Bone Augmentation Techniques in the Mandible Posterior Region

Not Applicable

Not yet recruiting

• Conditions: Bone Substitutes; Alveolar Bone Grafting

• Registration Number: NCT06661447
• Lead Sponsor: Universidad de Especialidades Espiritu Santo

Brief Summary

This study aims to compare the efficacy of two bone augmentation techniques in the posterior mandible. Twenty participants will undergo 40 surgical procedures at Espíritu Santo University (UEES) in Samborondon, Ecuador. Each patient will receive two types of bone grafts: one side will use autogenous cortical bone plates with a 50/50 mixture of autogenous bone and biomaterial (as described by Dr. Fouad Khoury), while the other side will use xenogenous cortical bone plates with the same mixture.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-02
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-25
• Last Update Submitted: 2024-10-25
• Study First Posted: 2024-10-28
• Last Update Posted: 2024-10-28
• Study Start: 2024-12-01
• Primary Completion: 2024-12-15
• Study Completion: 2029-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with Bilateral Mandibular Posterior Edentulous with atrophy in 4, 5 or 6 Cawood and Howell stages.
• Patients who have good plaque control of less than 20%
• Patients between 18-64 years old

Exclusion Criteria

• Systemically compromised patients
• Smoker patients
• Pregnant women, breastfeeding or use of oral contraceptives
• Patients who are taking medication that may affect healing and coagulation
• Patients with periodontal disease
• Patients who have undergone chemotherapy and radiotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To evaluate bone formation Across Different Graft Techniques	The evaluation will occur from enrollment through the end of treatment at 12 months. Assessments will be conducted preoperatively, 7 days post-surgery, as well as at 3, 6, and 12 months following the surgery.	This study aims to evaluate bone formation resulting from various bone grafting techniques, with a focus on quantifying the amount of newly formed bone.

Secondary Outcome Measures

Name	Time	Method
To evaluate the surgery duration of across different bone grafting techniques.	To record the duration of surgery for both techniques, from the administration of anesthesia to the final suture	This study aims to evaluate the surgery duration.
To evaluate bone quality across different bone grafting techniques.	From enrollment, to the end of treatment at 12 months; evaluating at 3 days, 30 days, 3 months, 6 months and 12 months	This will involve analyzing the bone density through radiographic imaging.
To evaluate postoperative inflammation across different bone grafting techniques.	The evaluation will occur prior to surgery, immediately postoperatively, on the 3rd day, 7th day, and at 14 days	This study aims to evaluate postoperative inflammation following surgery. A measurement will be taken from the corner of the lip to the ear lobe using a flexible measuring tape in order to monitor the swelling. The data will be recorded in millimeters.