Should bone grafts in the upper jaw be allowed to heal for 3 or 6 months before inserting dental implants?

Not Applicable

Completed

• Conditions: Bone allografting to support dental implants; Oral Health

• Registration Number: ISRCTN10993769
• Lead Sponsor: Semmelweis University Doctoral School of Clinical Medicine

Brief Summary

2021 Results article in https://doi.org/10.3390/ma14071810 (added 15/04/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-16
• Study Completion: 2020-01-02
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Systemically healthy patients aged over 18 years
2. Requiring implant prostheses and oral rehabilitation
3. Insufficient residual height in posterior maxilla requiring a sinus augmentation from lateral approach to insert the implants (residual crest height =5 mm)

Exclusion Criteria

1. Current pregnancy or intention to become pregnant during the study follow-up period
2. Sinusitis
3. Smoking
4. Alcoholism
5. Severe haematological disorder or disease
6. History of chronic hepatitis or liver cirrhosis
7. Diabetes mellitus with poor metabolic control
8. Receiving dialysis
9. Metabolic bone disease
10. Taking bisphosphonates drugs whether orally or intravenously
11. Undergoing or having received radiotherapy, chemotherapy or immunosuppressive therapy
12. Any other inability to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of newly formed bone calculated from bone biopsy samples collected from the site of dental implant placement by micro-CT and histomorphometry at 3 months (test group) and 6 months (control group) after surgery

Secondary Outcome Measures

Name	Time	Method
<br> 1. Percentage of residual graft calculated from bone biopsies collected from the site of dental implant placement by micro-CT and histomorphometry at 3 months (test group) and 6 months (control group) after surgery<br> 2. Percentage of connective tissue calculated from bone biopsies collected from the site of dental implant placement by micro-CT and histomorphometry at 3 months (test group) and 6 months (control group) after surgery<br> 3. Implant stability quotient (ISQ) measured with Osstell ISQ device at implant placement and 6, 8, 10, 12 weeks after surgical intervention<br>