Maxillary sinus bone deficiency due to tooth or teeth loss requiring sinus augmentation, implant placement, and oral rehabilitation Maxillary sinus augmentation Transcrestal sinus lift Lateral window sinus lift Concentrated growth factors CGF Xenograft Oral surgery Implantology Histomorphometry Micro-CT Patient-reported outcomes
Conditions
Interventions
Lateral window sinus augmentation performed using a combination of CGF and xenograft particles. The lateral window is prepared using one of the randomized techniques (Piezoelectric window or DASK wind
s venous blood using a standardized centrifugation protocol and delivered into the sinus through transcrestal access and implant placement is performed during the same session. Different transcrestal
Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery
cohort 1: Lateral window sinus augmentation using CGF + xenograft (DBBM),cohort 1: Lateral window sinus augmentation using xenograft (DBBM) alone,cohort 2: Transcrestal sinus augmentation using CGF al
Sponsors
Affiliated Stomatological Hospital, Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older. 2. Healthy or treated (non-surgical) periodontal diseases. 3. Need dental implants in the edentulous posterior maxilla with sinus lifting & augmentation procedures. 4. Simultaneous implant placement in the Transcrestal groups and Delayed implant placement in the Lateral Window groups [after 6 months of healing since the sinus augmentation procedure (for collection of bone specimens)]. 5. Less than 4 mm for Lateral Window groups and 4 - 6 mm for Transcrestal groups of residual alveolar bone height. 6. Sinus augmentation procedures are performed using one of the following materials: [CGF alone (only for Transcrestal groups )], [Bio-Oss bone substitute (DBBM) alone], and [Mixture of CGF + DBBM]. 7. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Compromised conditions or any medical history of systemic diseases contraindicating any oral and implant surgical procedures. 2. The presence of acute signs of infection at the implant's placement site or diseases affecting wound healing and osteogenesis. 3. Bruxism or any other oral parafunctions. 4. Heavy smoking or drug abuse. 5. Pregnancy or lactation females. 6. Recent history of radiotherapy or chemotherapy. 7. Poor oral hygiene and motivation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-operative sequel 1st, 3rd, and 10th/14th days after surgery includes (Wound healing assessment by Landry index and Numerical Rating Scale (NRS), Patient-reported outcomes (PROs) assessment, Complications assessment, Price calculations assessment) ,Micro-CT, Histomorphometric and immunohistochemical analyses 6 months post-augmentation Bone cores will be harvested at implant sites 6 months after sinus augmentation in the lateral window groups and processed for Micro-CT, Histomorphometric and immunohistochemical analysis.,3-D Radiographic outcomes and Implant stability quotient (ISQ) ISQ value after 6 months, Radiographic [Preoperative (T0), Immediately after implant placement (T1), after delivery by one mouth (T3), and at a One-year follow-up (T4)] ISQ value using ISQ device, and radiographic outcomes (Residual bone height, elevated height, Volumetric graft stability, marginal bone level, bone density) on CBCT | — |
Secondary
| Measure | Time frame |
|---|---|
| Esthetic, Late Complications, and Patient satisfaction assessments [Preoperative (T0), Immediately after implant placement (T1), after delivery by one mouth (T3), and at a One-year follow-up (T4)] Radiographically, visually using digital photos & direct measurements such as [tissue height & width, mucosal & papilla levels, biological & mechanical complications, Patient's Satisfaction, etc.,Survival and Success rates & Potential risk factors assessments [Preoperative (T0), Immediately after implant placement (T1), after delivery by one mouth (T3), and at a One-year follow-up (T4)] Radiographically, visually using digital photos and direct measurements | — |
Countries
China
Contacts
Public ContactYanjing Ou
Affiliated Stomatological Hospital, Fujian Medical University
Outcome results
None listed