Alveolar Bone Loss, Edentulous Jaw
Conditions
Keywords
atrophic mandible, bone augmentation, Decompression technique, alveolar ridge augmentation
Brief summary
This prospective split-mouth randomized controlled trial compared horizontal alveolar ridge augmentation using alloplastic bone graft versus xenograft, both performed simultaneously with implant placement using the decompression technique in the posterior mandible. Outcomes included postoperative edema, pain, soft tissue healing, and horizontal bone gain at 6 months assessed by CBCT.
Interventions
DEVICEAlloplastic bone graft
Alloplastic bone graft with collagen membrane, simultaneous implant placement with decompression technique
DEVICEXenograft
Xenograft with collagen membrane, simultaneous implant placement with decompression technique
Sponsors
Ege University
Bonegraft Biyolojik Malzemeler San. ve Tic. A.S.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Bilateral mandibular posterior edentulism with indication for implant-supported rehabilitation * Sufficient vertical bone height but insufficient horizontal bone width for implant placement * No infection at surgical site * Non-smoker * No head-and-neck radiotherapy within 2 years * No uncontrolled systemic disease (controlled systemic conditions with INR \<1.2 acceptable) * Signed informed consent
Exclusion criteria
* No indication for implant-supported prosthesis * Smoker * Active infection at surgical site * Head-and-neck radiotherapy within 2 years * Uncontrolled systemic disease * Allergy to study materials * Pregnancy * Age under 18 * Medications interfering with surgical procedures * History of mandibular fracture * Contraindication to surgery determined by consultation * Psychiatric disorder or inability to communication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Horizontal Alveolar Bone Gain | 6 months | Change in horizontal alveolar bone width measured by CBCT at baseline and 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Edema | 7 days | Facial edema assessed by measuring three surface distances (lateral orbital rim to mandibular angle, tragus to oral commissure, tragus to pogonion) at baseline, day 2, and day 7 |
| Postoperative Pain | 7 days | Postoperative pain assessed using the Visual Analogue Scale (VAS); score range 0-10; higher scores indicate worse pain. VAS scores recorded daily for 7 days |
| Soft Tissue Healing | 7 days | Wound healing assessed using the Landry wound healing index; score range 1-5; higher scores indicate better healing. Landry wound healing index assessed at postoperative days 2 and 7 |
Countries
Turkey (Türkiye)
Outcome results
None listed