Clinical Application Strategies of Maxillary Sinus Buccal Bony Window

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sinus Floor Augmentation; Maxillary Sinus
• Intervention / Treatment: Procedure: different methods for maxillary sinus floor elevation

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The Affiliated Hospital of Stomatology, Zhejiang University School of Medicine
      • Contact: Jinxing Hu; Phone Number: 18867155632; Email: jxhu@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: a: ground into pieces; 0~3mm	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
Experimental: b: replace the bone; 0~3mm	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
Experimental: c: turn inward; 0~3mm	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
Experimental: d: ground into pieces; 3~5mm	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
Experimental: e: replace the bone; 3~5mm	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
Experimental: f: turn inward; 3~5mm	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
RBH	Residual bone height (RBH): Only assessed at baseline	baseline

Collaborators and Investigators

• Sponsor: The Dental Hospital of Zhejiang University School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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/clr.13688. Epub 2020 Dec 26.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Anticipated): March 2, 2023
• Study Completion (Anticipated): December 31, 2032

Study Registration Dates

• First Submitted: March 12, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: RCT; CBCT; maxillary sinus floor elevation
• Other Study ID Numbers: 2021-126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No