Single Crown Supported by Short Implant Versus Standard Implant in Conjunction With Maxillary Sinus Floor Augmentation.

Aalborg University Hospital

Status: Active, not recruiting

Conditions: Dental Implant Failed

Treatments: Procedure: 40 patients will be randomly allocated to short implants and standard implants in conjunction with MSFA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04518020

N-20160047

Details and patient eligibility

About

Implant placement in the posterior part of the maxilla is frequently compromised due to atrophy of the alveolar process. Therefore, alveolar ridge augmentation is frequently necessary before or in conjunction with implant placement. The most commonly used method to augment the maxillary premolar and molar region involves the maxillary sinus floor augmentation (MSFA) with autogenous bone graft or a bone substitute. However, the use of autogenous bone grafts is associated with risk at the donor site morbidity and unpredictable graft resorption. Consequently, short implants are used increasingly to eliminate the need for bone augmentation. However, long-term studies comparing short implants and standard implants in conjunction with MSFA supporting single crown restoration in the posterior maxilla are missing. The primary outcome measures include survival of implant and suprastructures, peri-implant marginal bone level (MBL), professional evaluation of the suprastructure and soft tissue using pink esthetic score (PES) and white esthetic score (WES), patient satisfaction using visual analogue scale (VAS), and oral health related quality of life using oral health impact profile (OHIP-14) questionnaire. Secondary outcome measure include evaluation of the complication rate related to the two treatment modalities.

Full description

The primary objective of the present study is to test the H0 hypothesis of:

1. No differences in survival of suprastructures and implants with the two treatment modalities.
2. No differences in peri-implant MBL, PES, WES, and patient satisfaction using VAS with the two treat modalities.
3. No differences in oral health related quality of life using OHIP-14 with the two treatment modalities.

The secondary objective will include:

1. Complications related to bone harvesting, implant installation, and MSFA.

The primary outcome measures included:

• Survival of suprastructures.
• Survival of implants.
• Radiographic peri-implant MBL.
• Professional evaluation of suprastructure and soft tissue using PES and WES.
• Patient satisfaction using VAS
• Oral health related quality of life using OHIP-14 questionnaire.

Secondary outcome measures:

• Pre- and postoperative complications.

Enrollment: 40 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• >20 years
• Partial edentulism in the posterior maxilla.
• Height and weight of the maxillary alveolar process of at least 5.5 mm.
• Mandibular occluding teeth.

Exclusion criteria

• General contraindications to implant therapy.
• Poor oral hygiene.
• Progressive periodontitis.
• Acute infection in the area intended for implant placement.
• Parafunction, bruxism, or clenching.
• Psychiatric problems or unrealistic expectations.
• Heavy tobacco use, define as >10 cigarettes per day.
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Short implant

Active Comparator group

Description:

Short implant 6 mm installed

Treatment:

Procedure: 40 patients will be randomly allocated to short implants and standard implants in conjunction with MSFA

Conventional implant + bone augmentation

Other group

Description:

Standard length implant 13 mm in conjunction with maxillary sinus floor augmentation serves as a control group

Treatment:

Procedure: 40 patients will be randomly allocated to short implants and standard implants in conjunction with MSFA