NCT06463405

Brief Summary

The overall aim is to evaluate the patient-reported outcome and efficiency of replacing posterior teeth with implant-supported crowns compared to RDPs and no treatment. Sub-aims are to evaluate a new 3D-methods for registration of occlusion and to test two crown designs. Thus, the study design has three aims:

  • To analyze patient perception including OHRQoL, when missing posterior teeth are replaced with implant-supported crowns compared to removable dental prostheses (RDPs) or no replacement.
  • To develop and validate new 3D digital methods for assessing occlusal contacts between upper and lower jaw and to analyze the methods relation to masticatory ability and efficiency.
  • To compare the difference in biological technical outcomes between splinted and non-splinted implant-supported crowns over time.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
21mo left

Started Mar 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Mar 2024Jan 2028

Study Start

First participant enrolled

March 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 17, 2024

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

3.9 years

First QC Date

May 30, 2024

Last Update Submit

July 3, 2024

Conditions

Dental Occlusion

Keywords

Removable Partial DenturesDental ImplantsJaw relation record

Outcome Measures

Primary Outcomes (3)

  • Oral Health Related Quality of Life score

    Up to 5 years

  • Oral Function change in percentage

    Up to 5 years

  • Marginal Bone Loss in mm

    Up to 5 years

Study Arms (2)

Splinted implant restorations

OTHER
Other: Splinted

Non-splinted implant restorations

OTHER
Other: Splinted

Interventions

SplintedOTHER

The investigators will compare splinted versus non-splinted crowns in a randomized design. Whether the crowns will be splinted or not are decided by distant randomization separate from clinicians conducting the trial. Twenty sealed envelopes will be opened where its stands whether the crowns has to be splinted crowns or non-splinted crowns. The implants in the splinted side will have an intermediate titanium abutment and impression will be taken at abutment level, whereas impressions in the non-splinted side will be taken directly at the fixture level. The splinted as well as the non-splinted crowns will be screw-retained and produced in monolithic zirconia. An open-tray technique / (scanning) will be used for both reconstructions.

Also known as: Non-splinted
Non-splinted implant restorationsSplinted implant restorations

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Untreated or active, progressive periodontitis
  • Intake of (high dose) antiresorptive medicine or earlier medication related osteonecrosis of the jaw
  • Therapeutic radiation to the head and neck
  • Uncontrolled diabetes or systemic corticosteroids
  • Heavy smoking (\>20 cigarettes/day)
  • An inability to open the mouth wide enough to place implants
  • Decayed or unrestored anterior/premolar teeth
  • Need for major bone augmentation (e.g., bone block graft, extensive augmentations with second operation for implant insertion)
  • \< 8 mm bone height to the alveolar nerve or sinus maxillaris
  • Parafunctional habits or untreated temporomandibular dysfunctions or orofacial pain
  • Unable to cooperate or too ill to complete the experiment
  • Lack of signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health and Medical Sciences

Copenhagen, 2200, Denmark

RECRUITING

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Central Study Contacts

Chahak Seth-Johansen, DDS

CONTACT

+4551410210chahak.seth@sund.ku.dk

Klaus Gotfredsen, DDS

CONTACT

+4535332934klg@sund.ku.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 30, 2024

First Posted

June 17, 2024

Study Start

March 1, 2024

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Last Updated

July 5, 2024

Record last verified: 2024-07

Locations

DK(1)