None listed
Conditions
Brief summary
The aim of this controlled clinical trial was to test whether implant supported restorations have similar biological and technical outcomes when placed into previously augmented maxillary sinuses via the lateral wall approach using stabilized anorganic bovine bone mineral, as used in defined clinical scenarios (i.e. reduced local autogenous bone availability and/or sinus membrane perforation), when compared to those placed into a composite graft of anorganic bovine bone mineral and autogenous bone.
Interventions
2 arm non-randomized clinical trial comparing outcomes of implant supported restorations when placed into previously lateral wall augmented maxillary sinuses (MSA)
(treatment groups) both groups received the same tissue level SLA dental implant.
Test group - collagen stabilized anorganic bovine bone mineral (ABBM-C)
Control group: composite graft of anorganic bovine bone mineral (ABBM) and autogenous bone
(Intervention) lateral wall maxillary sinuse augmentation then dental implant placement
2 arm non-randomized clinical trial comparing outcomes of implant supported restorations when placed into previously lateral wall augmented maxillary sinuses (MSA) (treatment groups) both groups received the same tissue level SLA dental implant. Test group - collagen stabilized anorganic bovine bone mineral (ABBM-C) Control group: composite graft of anorganic bovine bone mineral (ABBM) and autogenous bone (Intervention) lateral wall maxillary sinuse augmentation then dental implant placement and finally restoration. (clinician performing intervention) specialist Periodontist (type of intervention) clinical / surgical (No. of times intervention carried out) Once. Outcomes of the dental implants measured after 1 year and then after 5 years of function (location) private practice - level 1 141 Queen street Brisbane QLD 4000 (g) NA MSA - 2hrs Implant placement - 1hr Restoration - 1hr Review - 30min 2. Treatment allocation was based on defined clinical scenarios - reduced local autogenous bone availability and/or sinus membrane perforation received ABBM-C.
Sponsors
jamil alayan
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Individuals were at least 18 years of age, medically healthy or with mild controlled systemic disease, able to undergo oral surgical procedures under local or general anaesthesia (ASA I and II; American Society of Anesthesiologists, Schaumburg, Illinois, USA). • Must present with a bone deficiency in the maxillary sinus region, which necessitates sinus floor augmentation • If bilateral sinus augmentation was required, only one sinus was randomly selected and used for the purposes of this study. • Residual alveolar bone height of the edentulous maxilla below the floor of the maxillary sinus: less than or equal to 4.5 mm and greater than or equal to 1 mm (measured at the mid-point of the edentulous space where both the coronal and sagittal planes intersect) and residual alveolar bone width of equal to or greater than 6mm. • Teeth at the surgical site which required removal were extracted a minimum of 12 weeks prior to sinus floor elevation • Patients with a history of periodontal disease as assessed by specialist Periodontists (JA & SI) and according to the criteria of Armitage (Armitage 1999) were treated and deemed to be stable prior to sinus augmentation surgery. Stability was defined as having a full mouth bleeding score of equal to or less than 20% and no sites of residual periodontal probing depth of less than and equal to 5mm (Lang & Tonetti 2003).
Exclusion criteria
• Pregnancy at the time of recruitment • Physical handicaps that interfere with the ability to perform adequate oral hygiene • Alcoholism or chronic drug abuse • Patients who smoke more than 10 cigarettes per day • Medications which interferes with bone formation • Mucosal diseases such as Lichen Planus • History of local radiation therapy • Severe bruxism or clenching habits • Signs and symptoms consistent with acute maxillary sinusitis • Significant soft tissue thickening or sinus opacification in the sinus of interest. • Previous bone augmentation or dental implant placement in the posterior maxilla • Benign or malignant tumours of the maxillary sinus • Pathological conditions that severely impact mucociliary clearance including; Chronic sinusitis, Primary Ciliary Dyskinesia or Cystic Fibrosis.
Outcome results
None listed