Clinical trial NCT04518020: Single Crown Supported by Short Implant Versus Standard Implant in Conjunction With Maxillary Sinus Floor Augmentation.
Official title: Single Crown Supported by Short Implant Versus Standard Implant in Conjunction With Maxillary Sinus Floor Augmentation in the Posterior: a Randomized, Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dental Implant Failed
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Dentsply International
First posted: 2020-08-19
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial (RCT)
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival of suprastructures.
timeFrame: 1-year follow up
measure: Survival of implants.
timeFrame: 1-year follow up
measure: Radiographic MBL.
timeFrame: 1-year follow up
measure: Professional evaluation of the prosthetic restoration and soft tissue using pink esthetic score (PES) and white esthetic score (WES).
timeFrame: 1-year follow up
measure: Patient satisfaction.
timeFrame: 1-year follow up
measure: Oral health related quality of life as defined by oral health impact profile (OHIP-14).
timeFrame: 1-year follow up
Secondary outcomes:
measure: Complications.
timeFrame: 1-year follow up
Other outcomes:
Locations:
Study officials:
References:
citation: Nielsen HB, Schou S, Bruun NH, Starch-Jensen T. Single-crown restorations supported by short implants (6 mm) compared with standard-length implants (13 mm) in conjunction with maxillary sinus floor augmentation: a randomized, controlled clinical trial. Int J Implant Dent. 2021 Jul 16;7(1):66. doi: 10.1186/s40729-021-00348-5.