Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID05315791

Clinical Application Strategies of Maxillary Sinus Buccal Bony Window With Different Residual Bone Heights in Lateral Maxillary Sinus Floor Elevation

Led by The Dental Hospital of Zhejiang University School of Medicine · Updated on 2022-04-07

60

Participants Needed

1

Research Sites

513 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The trial investigates different surgical methods for maxillary sinus floor elevation in participants who have varying residual bone heights of 0 to 5 millimeters. Researchers aim to identify the best operating technique by comparing approaches using the maxillary sinus buccal bony window. This research involves adults aged 18 to 80 years who need sinus floor augmentation and seeks to assist surgeons in selecting optimal procedures for patients with differing bone conditions. Participants are assigned randomly to one of six groups based on their residual bone height and the surgical method used. The methods include grinding the bone into pieces, replacing the bone, or turning the bone inward to support the membrane. These approaches are applied during lateral maxillary sinus floor elevation surgery. The study enrolls 60 participants divided by bone height categories: 0 to 3 mm and 3 to 5 mm. Throughout the study, researchers collect participant information and analyze Cone Beam Computed Tomography (CBCT) data. They measure outcomes such as changes in alveolar bone height and the extent of new bone growth at multiple time points: before surgery, and 6 months, 1, 2, 3, 5, and 10 years after surgery. The study also monitors residual bone height at baseline. This comprehensive follow-up evaluates which surgical strategy performs best over the long term.

CONDITIONS

Brief Title

Clinical Application Strategies of Maxillary Sinus Buccal Bony Window

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • A single maxillary posterior tooth was missing for at least 3 months
  • Gingival distance of 4 millimeters or more
  • Residual bone height 5 millimeters or less and residual bone width 6 millimeters or more
  • Good overall health
  • Complete and clear CBCT image without artifacts affecting measurement
  • Provided informed consent
Not Eligible

You will not qualify if you...

  • Untreated diabetes or other serious systemic diseases
  • Untreated periodontal disease
  • Uncontrolled periapical lesions of adjacent teeth
  • Bone diseases such as osteoporosis or osteosclerosis
  • Severe night bruxism
  • Mental illness
  • Pregnant or breastfeeding

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Day of surgery

Participants undergo maxillary sinus floor elevation surgery using one of the different maxillary sinus buccal bony window methods based on their residual bone height.

1 visit (in-person)

Post-operative Follow-up

Duration - Up to 10 years after surgery

Participants are followed to collect CBCT data and monitor changes in alveolar bone height and bone graft stability over time after surgery.

Visits at 6 months, and 1, 2, 3, 5, and 10 years after surgery

Trial Site Locations

Total: 1 location

1

The Affiliated Hospital of Stomatology, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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Published Research Related To This Trial

The comparative evaluation of transcrestal and lateral sinus floor elevation in sites with residual bone height ≤6 mm: A two-year prospective randomized study.

Yiqun Zhou, Yang Shi, Misi Si...

https://pubmed.ncbi.nlm.nih.gov/33220090