Clinical Application Strategies of Maxillary Sinus Buccal Bony Window

NCT05315791 | Recruiting

• 1 other identifier: 2021-126
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sinus Floor Augmentation; Maxillary Sinus

Keywords

maxillary sinus floor elevation; CBCT; RCT

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (6)

a: ground into pieces

EXPERIMENTAL

0\~3mm

Procedure: different methods for maxillary sinus floor elevation

b: replace the bone

EXPERIMENTAL

0\~3mm

Procedure: different methods for maxillary sinus floor elevation

c: turn inward

EXPERIMENTAL

0\~3mm

Procedure: different methods for maxillary sinus floor elevation

d: ground into pieces

EXPERIMENTAL

3\~5mm

Procedure: different methods for maxillary sinus floor elevation

e: replace the bone

EXPERIMENTAL

3\~5mm

Procedure: different methods for maxillary sinus floor elevation

f: turn inward

EXPERIMENTAL

3\~5mm

Procedure: different methods for maxillary sinus floor elevation

Interventions

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

a: ground into pieces; b: replace the bone; c: turn inward; d: ground into pieces; e: replace the bone; f: turn inward

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The Affiliated Hospital of Stomatology, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 29142655 RESULT

• 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.

  PMID: 29691967 RESULT

• 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.

  PMID: 33220090 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 12, 2022
• First Posted: April 7, 2022
• Study Start: March 10, 2022
• Primary Completion: March 2, 2023
• Study Completion (Estimated): December 31, 2032
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)