NCT07526337

Brief Summary

Maxillary posterior area is the most challenging site for dental implant placement. Indeed, complex remodeling processes, resulting in changes of the maxillary sinus and shape of the alveolar ridge will cause difficulties in rehabilitating the posterior maxillae sites. Various techniques have been proposed in order to achieve the necessary bone volume for the placement of long term successful implants. However, unbalanced crown to implant ratio remains a risk factor after successful dental implants installation following sinus graft. No study on humans assessed the effect of apical positioning of the implants in posterior grafted sites (sinus graft or sinus graft + vertical GBR) on the following clinical parameters: The peri-implant bone remodeling (vertical bone loss (mm) and probing depth (mm) around the implants, crown bulkiness, emergence profile and crown height, and Patients satisfaction, food impaction (PROM)). This study will elucidate these points and based on the parameter's results, suggest a treatment based classification facilitating the treatment decision-making of the clinicians in case of an atrophic posterior maxilla; aiming to ensure a long-term successful supra-implant rehabilitation which will maintain its bio-mechanically and biological success.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
Jan 2025May 2026

Study Start

First participant enrolled

January 1, 2025

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

April 6, 2026

Last Update Submit

April 6, 2026

Conditions

Keywords

alveolar bone atrophydigital planningguided bone regenerationmaxillary sinusperi-implant diseaseperi-implantitssinus floor augmentationvertical ridge deficiency

Outcome Measures

Primary Outcomes (3)

  • peri-implant marginal bone remodeling (mm)

    Recorded at the mesial and distal aspect of each implant. The distance from the implant-abutment interface to the first bone-to-implant contact (bone level) was assessed on peri-apical radiographs taken with the long cone paralleling technique that were taken during the recall visits (after implant loading). Bone Level values were calibrated according to the actual implant length, following the next formula, according to Chen et al. 2023: (99) The BL was measured at the mesial (M) and distal (D) aspects of each implant at baseline (initial bone level, IBL) and follow-up (final bone level, FBL). The change in MBL was calculated as the difference between the mean FBL and mean IBL. The following formulas were used: (99).

    3 years

  • - Pocket probing depth (mm).

    is measured with the periodontal probe Hu-Friedy Periodontal Probe PCP UNC15 (Hu-Friedy, Chicago, Illinois), going parallel to the axis of the implant to the nearest 0.5 mm, at 6 different sites per implant (mesiobuccal, buccal, distobuccal, mesiopalatal, palatal, distopalatal)

    1 week

  • - Bleeding on probing.

    analyzed 15 seconds following pocket probing around 6 sites per implant.

    1 week

Secondary Outcomes (5)

  • - Keratinized tissue width (mm).

    1 week

  • - Crown-to-implant ratio

    1 week

  • - Crown height and diameter

    1 week

  • - Emergence angle (supra-implant crown bulkiness and height)

    1 week

  • patient reported outcome measures (PROMs)

    1 week

Study Arms (1)

1

partially edentulous patients having an implant rehabilitation treated with a sinus lift procedure in the atrophic posterior maxilla

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study consists of recruiting a number of files of patients having placed posterior implants in an atrophic posterior maxilla treated with a sinus augmentation procedure.

You may qualify if:

  • \- Patient aged more than 18 years.
  • Partially edentulous patients having an implant rehabilitation treated with a sinus lift procedure in the atrophic posterior maxilla.
  • Patient with no systemic disease that contraindicate the surgical procedure as uncontrolled diabetes mellitus, bleeding disorders, recent myocardial infarction, head and neck radiation, and mental disorders.

You may not qualify if:

  • \- Fully Edentulous patients.
  • Patients presenting sinus pathologies (sinusitis, thickening of the membrane).
  • Patient smoking more than 20 cigarettes.
  • Patient taking systemic drugs that could affect bone healing as immune suppressive drugs and bisphosphonates.
  • Patient with systemic disease that contraindicate the surgical procedure as uncontrolled diabetes mellitus, bleeding disorders, recent myocardial infarction, head and neck radiation, and mental disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Joseph University of Beirut

Beirut, Beyrouth, 1000, Lebanon

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Joseph Ryan Younes, Doctor of Dental Surgery

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 13, 2026

Study Start

January 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations