Clinical Application Strategies of Maxillary Sinus Buccal Bony Window

Maxillary Sinus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05315791
• Other study ID #: 2021-126
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: December 31, 2032

Study information

• Verified date: March 2022
• Source: The Dental Hospital of Zhejiang University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2032
• Est. primary completion date: March 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Maxillary Sinus
• Sinus Floor Augmentation

Intervention

Procedure:
• different methods for maxillary sinus floor elevation
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

Locations

Country	Name	City	State
China	The Affiliated Hospital of Stomatology, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Dental Hospital of Zhejiang University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (3)

Niu L, Wang J, Yu H, Qiu L. New classification of maxillary sinus contours and its relation to sinus floor elevation surgery. Clin Implant Dent Relat Res. 2018 Aug;20(4):493-500. doi: 10.1111/cid.12606. Epub 2018 Apr 25. — View Citation

Starch-Jensen T, Jensen JD. Maxillary Sinus Floor Augmentation: a Review of Selected Treatment Modalities. J Oral Maxillofac Res. 2017 Sep 30;8(3):e3. doi: 10.5037/jomr.2017.8303. eCollection 2017 Jul-Sep. Review. — View Citation

Zhou Y, Shi Y, Si M, Wu M, Xie Z. The comparative evaluation of transcrestal and lateral sinus floor elevation in sites with residual bone height =6 mm: A two-year prospective randomized study. Clin Oral Implants Res. 2021 Feb;32(2):180-191. doi: 10.1111/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ABH change	Apical bone height (ABH): Represented the grafted height at baseline and the grafted height with neo-formed bone at follow-ups.	baseline, 6 months, and 1, 2, 3, 5, 10 years after the surgery
Primary	ESBG change	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.	baseline, 6 months, and 1, 2, 3, 5, 10 years after the surgery
Primary	RBH	Residual bone height (RBH): Only assessed at baseline	baseline