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

Dental Implant Failed Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04518020
• Other study ID #: N-20160047
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 16, 2016
• Est. completion date: July 1, 2025

Study information

• Verified date: July 2022
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Implant Failed

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University Hospital	Dentsply International

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Radiographic MBL.	Measurement of marginal bone level in millimeter.	1-year follow up
Primary	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
Primary	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
Primary	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	Complications.	Evaluation of biological and mechanical complication rate.	1-year follow up