Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT04518020
Status:
UNKNOWN
Last Update Posted:
2022-07-20
First Post:
2020-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single Crown Supported by Short Implant Versus Standard Implant in Conjunction With Maxillary Sinus Floor Augmentation.
Sponsor:
Aalborg University Hospital
Organization:
Study Overview
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.
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: