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

NCT04518020 | Unknown

• 1 other identifier: N-20160047
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Implant Failed

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Complications.

  1-year follow up

Study Arms (2)

Short implant

ACTIVE COMPARATOR

Short implant 6 mm installed

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

Conventional implant + bone augmentation

OTHER

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

Interventions

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

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).

Conventional implant + bone augmentation; Short implant

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Dentsply International: collaborator

Related Publications (1)

• 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.

  PMID: 34268630 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD. Student, Department of Oral and Maxillofacial Surgery

Model Details: Randomized controlled clinical trial (RCT)

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 19, 2020
• Study Start: November 16, 2016
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2025
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share