Guided Bone Regeneration
Conditions
Keywords
GBR, Tacs
Brief summary
To address the gap of knowledge in comparing between the bone augmentation outcomes with or without tacks for membrane stabilization
Interventions
PROCEDUREGuided Bone regeneration
After local anesthesia, a crestal incision will be performed followed by full-thickness mucoperiosteal flap elevation Flap advancement will be attained through periosteal scoring of the buccal; The resorbable collagen membrane (Bio Gide, Geistlich AG) will be trimmed to the defect size. Xenograft (Bio-Oss) together with scrapped autogenous bone will be mixed and placed at the surgical site. The membrane will positioned over the graft and tucked into the lingual flap. Patient allocation concealment will be broken and the patients will be randomly assigned into two groups Patients receiving horizontal bone augmentation with resorbable collagen membrane stabilized with no tacks. The first layer will be closed with horizontal mattress sutures placed 4 mm from the incision line, and single interrupted sutures are used to close the edges of the flap. Vertical incisions are closed using single interrupted sutures and mattress suture should remain in place for at least 2 to 3 weeks
Sponsors
Misr International University
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients with at least 1 missing tooth in the posterior mandibular area Patients with an age above 18 years Systemically healthy patients Healed alveolar ridge for implant placement with: * Deficient buccolingual dimension ( ≤5mm) * Sufficient vertical height (≥ 10 mm) * Sufficient mesio-distal width (≥ 6.5 mm) Inter-arch space ≥ 7 mm to allow space for implant-supported crown Presence of neighboring and opposing dentition Soft tissue phenotype with keratinized tissue width (KTW) (≥2 mm) and gingival thickness (≥2 mm) Good oral hygiene Cooperative patients who accepted the trial follow up period and sign the informed consen
Exclusion criteria
* Systemic diseases or medications that might affect bone metabolism, increase surgical risk or complicate post-operative healing Untreated periodontal diseases History of radiation therapy to the head and neck Heavy smokers (≥ 10 cigarettes per day) Pregnant or lactating females Alcoholism or drug abuse Psychiatric problems Patients with signs of acute infection related to the area of interest
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Horizontal bone gain assessed radiographically (mm) | Baseline , 4 month | Using CBCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Pain | 7 days | Visual Analogue Scale (VAS) (Price et al., 1983) |
| Patient satisfaction | 4 month | Questionnaire - Binary |
| Surgical Time | During Surgery | Stop Watch |
| Horizontal bone gain assessed clinically (mm) | Baseline , 4 month | Bone Caliper |
| Histological Evaluation | 4 month | Core Biopsy |
Contacts
Primary ContactYahya Amer, PhD
Outcome results
None listed