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NCT Number: NCT05315791

Clinical Application Strategies of Maxillary Sinus Buccal Bony Window

Through randomized controlled trials, investigators will recruit participants who need maxillary sinus floor elevation with different residual bone height, and utilize the maxillary sinus buccal bony window during the surgery. Then investigators will gather the related information of participants, collect and analyze their CBCT data, in order to help surgeons select the best operating method for different patients.

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Key information

Conditions

Sinus Floor Augmentation Maxillary Sinus

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Hospital of Stomatology, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location status: Recruiting

Location contact

Jinxing Hu

CONTACT

[email protected]

18867155632

About this study

Through randomized controlled trials, investigators will recruit 60 participants who need maxillary sinus floor elevation with different residual bone height (0~3mm; 3~5mm), and utilize the maxillary sinus buccal bony window during the surgery (A: ground into pieces; B: replace the bone; C: turn inward to hold up the membrane). Then investigators will gather the related information of participants, collect and analyze their CBCT data, in order to help surgeons select the best operating method for different patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A single maxillary posterior tooth was missing, and the missing time was ≥ 3 months
  • Gingival distance ≥ 4mm
  • Residual bone height ≤ 5mm and residual bone width ≥ 6mm
  • Good systemic health
  • CBCT image was complete and clear, and there was no obvious artifact affecting the measurement
  • Informed consent.

Exclusion criteria

  • Untreated diabetes or other serious systemic diseases
  • Untreated periodontal disease
  • Uncontrolled periapical lesions of adjacent teeth
  • Certain bone diseases such as osteoporosis and osteosclerosis
  • Severe night bruxism
  • Mental illness
  • Pregnant or breast-feeding patients.

Treatment and study plan

different methods for maxillary sinus floor elevation

Procedure

a: 0~3mm+ground into pieces; b: 0~3mm+replace the bone; c: 0~3mm+turn inward to hold up the membrane; d: 3~5mm+ground into pieces; e: 3~5mm+replace the bone; f: 3~5mm+turn inward to hold up the membrane

Primary outcomes

  1. ABH change

    Time frame: baseline, 6 months, and 1, 2, 3, 5, 10 years after the surgery

    Apical bone height (ABH): Represented the grafted height at baseline and the grafted height with neo-formed bone at follow-ups.

  2. ESBG change

    Time frame: baseline, 6 months, and 1, 2, 3, 5, 10 years after the surgery

    Endo-sinus bone gain (ESBG): ESBG = ABH + implant protrusion length at baseline; ESBG represented the grafted height and neo-formed bone, and described the height difference of radiopaque area in the sinus cavity at different times.

  3. RBH

    Time frame: baseline

    Residual bone height (RBH): Only assessed at baseline

Sponsors and collaborators

Lead sponsor

The Dental Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2032
First posted
Apr 7, 2022
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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