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

Single Crown Supported by Short Implant Versus Standard Implant in Conjunction With Maxillary Sinus Floor Augmentation in the Posterior: a Randomized, Controlled Clinical Trial.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Implant Failed
• Intervention / Treatment: Procedure: 40 patients will be randomly allocated to short implants and standard implants in conjunction with MSFA

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Short implant; Short implant 6 mm installed	Procedure: 40 patients will be randomly allocated to short implants and standard implants in conjunction with MSFA; 40 patients will be randomly allocated to short implants (group 1) and standard implants in conjunction with MSFA using 50% particulated autogenous mandibular bone graft mixed with 50% Bio-Oss (group 2).
Other: Conventional implant + bone augmentation; Standard length implant 13 mm in conjunction with maxillary sinus floor augmentation serves as a control group	Procedure: 40 patients will be randomly allocated to short implants and standard implants in conjunction with MSFA; 40 patients will be randomly allocated to short implants (group 1) and standard implants in conjunction with MSFA using 50% particulated autogenous mandibular bone graft mixed with 50% Bio-Oss (group 2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival of suprastructures.	Survival of suprastructures is defined as absence of mechanical/or biological complications causing loss of suprastructures. Chipping of ceramics and loosening of the suprastructure were not categorized as loss of suprastructure.	1-year follow up
Survival of implants.	Survival of implants is defined as clinically stable and osseointegrated implants with absence of mobility, progressive marginal bone loss, and infection.	1-year follow up
Radiographic MBL.	Measurement of marginal bone level in millimeter.	1-year follow up
Professional evaluation of the prosthetic restoration and soft tissue using pink esthetic score (PES) and white esthetic score (WES).	Esthetic evaluation of suprastructure and soft tissue using PES and WES. PES includes 7 different variables: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue colour, and texture. Each variable is assessed with a 0, 1, or 2 score, with 0 being the poorest score and 2 the best according to the degree of match or mismatch compared with the anterior premolar or molar. The highest possible PES is 14. WES includes 5 different variables: Crown form, volume, colour, translucency, and texture. Each variable is assessed with a 0, 1, or 2 score, with 0 being the poorest score and 2 the best according to the degree of match or mismatch compared with the anterior premolar or molar. The highest possible WES is 10.	1-year follow up
Patient satisfaction.	Evaluation of patient satisfaction using visual analogue scale (VAS). VAS with 0 indicating extreme dissatisfaction and 10 indicating complete satisfaction.	1-year follow up
Oral health related quality of life as defined by oral health impact profile (OHIP-14).	Evaluation of oral health related quality of life using OHIP-14 questionnaire. OHIP-14 scale ranges from 0 to 56, with higher scores indicating poorer oral health impact profile.	1-year follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications.	Evaluation of biological and mechanical complication rate.	1-year follow up

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Collaborators: Dentsply International

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2016
• Primary Completion (Actual): July 1, 2021
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: N-20160047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No