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

Maxillary sinus augmentation with A-RRF and serum albumin-coated allograft- prospective randomized trial for the determination of the optimal healing time for dental implant loading

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10993769

Enrollment

Registered

2019-10-16

Start date

2018-10-01

Completion date

Unknown

Last updated

2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone allografting to support dental implants Oral Health

Interventions

The surgical procedure and the applied grafts for sinus augmentation from lateral approach are the same for both study arms. Grafting materials are advanced platelet rich fibrin (A-PRF) in combinatio

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 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 3. Implant stability quotient (ISQ) measured with Osstell ISQ device at implant placement and 6, 8, 10, 12 weeks after surgical intervention	—

Measure

Time frame

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 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 3. Implant stability quotient (ISQ) measured with Osstell ISQ device at implant placement and 6, 8, 10, 12 weeks after surgical intervention

—

Countries

Hungary

Contacts

Public ContactBálint Trimmel

trimmel.balint@dent.semmelweis-univ.hu+36308412533

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026