Biological & technical outcomes of restored implants after maxillary sinus augmentation using xenograft / autogenous bone & collagen-stabilized xenograft – results at 1 year loading

Not Applicable

Active, not recruiting

• Conditions: outcomes of maxillary Sinus augmentation; Outcomes of restored dental Implants in maxillary sinus augmentation; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12619000526178
• Lead Sponsor: jamil alayan

Brief Summary

A survival rate of 100% was reported. No significant inter-group differences were noted for all parameters. Radiographic assessment at baseline revealed mean (SD) marginal bone loss of 0.66mm (0.40) and 0.77mm (0.48) from the implant shoulder in the control and test group respectively. After 12 months of loading a mean (SD) additional marginal bone loss of 0.32mm (0.24) and 0.35mm (0.23) was noted in the control and test group respectively. Mucositis (=1 site BOP) was diagnosed in 62.9% of control & 69.23% of test patients. Peri-implantitis was not diagnosed in any patient. Screw retention and single crowns predominated. Technical complications mostly comprised of ceramic veneer chipping and was noted in 7.4% of control and 11.54% of test patients.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-02
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
radiographic assessment of interproximal marginal bone levels (DIB)[ 1 year after delivery of prosthesis<br>5 years after delivery of prosthesis]

Secondary Outcome Measures

Name	Time	Method
Peri-implant tissue health assessment - composite (includes probing depth, gingival recession, bleeding on probing, plaque index). Assessed by clinical examination. <br><br>[ 12 months after prosthesis delivery<br>5 years after delivery of prosthesis];Implant supported restoration assessment - composite<br>Assessed by clinical examination. <br>[ 12 months after prosthesis delivery<br>5 years after delivery of prosthesis];Dental implant survival. Assessed by clinical examination. [ 12 months after prosthesis delivery<br>5 years after delivery of prosthesis];Implant restoration survival. Assessed by clinical examination. [ 12 months after prosthesis delivery<br>5 years after delivery of prosthesis];Maxillary sinus graft stability [ 5 years after delivery of prosthesis assessed by radiographically]