Digital Planning and Clinical Assessment of the Treated Atrophic Posterior Maxilla With a Sinus Lift Procedure: a Cross-sectional Study.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSaint-Joseph University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

- 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.

Disqualifiers

- 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.

Trial 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.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: 1

Trial outcomes

Primary outcomes

1

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).

Time frame
3 years
2

- 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)

Time frame
1 week
3

- Bleeding on probing.

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

Time frame
1 week

Secondary outcomes

1

- Keratinized tissue width (mm).

at the buccal aspect of every implant with a periodontal probe

Time frame
1 week
2

- Crown-to-implant ratio

The crown-to-implant ratio was determined by dividing the length of the superstructure (crown and the abutment) by the length of the implant that was placed crestally.

Time frame
1 week
3

- Crown height and diameter

of the fixed dental prosthesis (FDPs) on implants, using a periodontal probe.

Time frame
1 week
4

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

The supra-implant restoration bulkiness and height (mm) will be measured by measuring the emergence profile angle. A straight line will be drawn along the mesial and distal edge of the long axis of the implant, and the included angle between the lines tangent to the contour of the prosthesis is the emergence angle, and the mesial and distal emergence angles of the prosthesis are measured.

Time frame
1 week

Other outcomes

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