Dental Implant FailedNCT04518020
Single Crown Supported by Short Implant Versus Standard Implant in Conjunction With Maxillary Sinus Floor Augmentation.
A study testing 40 patients will be randomly allocated to short implants and standard implants in conjunction with MSFA in people with Dental Implant Failed, run by Aalborg University Hospital.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed
- What is being tested?
- 40 patients will be randomly allocated to short implants and standard implants in conjunction with MSFA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 16 Nov 2016to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >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.
Who cannot join
- 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
About this study
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.
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.
Read the detailed description
The primary objective of the present study is to test the H0 hypothesis of:
- No differences in survival of suprastructures and implants with the two treatment modalities.
- No differences in peri-implant MBL, PES, WES, and patient satisfaction using VAS with the two treat modalities.
- No differences in oral health related quality of life using OHIP-14 with the two treatment modalities.
The secondary objective will include:
- 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.
- Conditions
- Dental Implant Failed
- Being tested
- 40 patients will be randomly allocated to short implants and standard implants in conjunction with MSFA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40 patients will be randomly allocated to short implants and standard implants in conjunction with MSFAProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Short implant | Active comparator | Short implant 6 mm installed Receives: 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 Receives: Procedure: 40 patients will be randomly allocated to short implants and standard implants in conjunction with MSFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1-year follow up
Radiographic MBL.
Measurement of marginal bone level in millimeter.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1-year follow up
Secondary outcomes (1)
Complications.
Evaluation of biological and mechanical complication rate.
Measured: 1-year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start16 Nov 2016
- Primary completion1 Jul 2021
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Implant FailedStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial (RCT)
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply International
- Responsible party
- Principal investigator, Helle Baungaard Nielsen, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518020
- Sponsor's protocol ID
- N-20160047
- Status last verified
- Jul 2022
- First submitted
- 12 Aug 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34268630
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04518020
- Acronym / sponsor ID
- N-20160047
- Conditions
- Dental Implant Failed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Dentsply International
- Study start
- 16 Nov 2016 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- No differences in survival of suprastructures and implants with the two treatment modalities.
- No differences in peri-implant MBL, PES, WES, and patient satisfaction using VAS with the two treat modalities.
- No differences in oral health related quality of life using OHIP-14 with the two treatment modalities.
The secondary objective will include:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Short implant | Active comparator | Procedure: 40 patients will be randomly allocated to short implants and standard implants in conjunction with MSFAShort implant 6 mm installed |
| Conventional implant + bone augmentation | Other | Procedure: 40 patients will be randomly allocated to short implants and standard implants in conjunction with MSFAStandard length implant 13 mm in conjunction with maxillary sinus floor augmentation serves as a control group |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >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.
Key exclusion criteria (8 listed)
- General contraindications to implant therapy.
- Poor oral hygiene.
- Progressive periodontitis.
- Acute infection in the area intended for implant placement.
- Parafunction, bruxism, or clenching.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 40 patients will be randomly allocated to short implants and standard implants in conjunction with MSFA40 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). | Procedure or surgery | Conventional implant + bone augmentation, Short implant |
Primary outcome
Survival of suprastructures.
Time frame: 1-year follow up
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.
Survival of implants.
Time frame: 1-year follow up
Survival of implants is defined as clinically stable and osseointegrated implants with absence of mobility, progressive marginal bone loss, and infection.
Radiographic MBL.
Time frame: 1-year follow up
Measurement of marginal bone level in millimeter.
Professional evaluation of the prosthetic restoration and soft tissue using pink esthetic score (PES) and white esthetic score (WES).
Time frame: 1-year follow up
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.
Patient satisfaction.
Time frame: 1-year follow up
Evaluation of patient satisfaction using visual analogue scale (VAS). VAS with 0 indicating extreme dissatisfaction and 10 indicating complete satisfaction.
Oral health related quality of life as defined by oral health impact profile (OHIP-14).
Time frame: 1-year follow up
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 secondary outcome
Complications.
Time frame: 1-year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Derived from this study: PubMed 34268630Nielsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 40 patients will be randomly allocated to short implants and standard implants in conjunction with MSFA in people with Dental Implant Failed, run by Aalborg University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of suprastructures. (time frame: 1-year follow up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04518020, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.