No registrations found.
ID
Source
Brief title
Health condition
Missing teeth
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Change in peri-implant marginal bone level.
Secondary outcome
• Implant survival;
• Probing depth;
• Modified Plaque-Index, Modified Bleeding-Index and Gingiva-Index;
• Patient satisfaction;
• Technical complications from start until the one-year follow-up.
Background summary
Rationale: Implant-supported single restorations show good long-term radiographical and clinical results after delayed loading. Implant loading protocols are shifting towards immediate loading. While delayed loading requires a non-functional healing period of at least 3 months after implant placement, immediate loading consists of placing a restoration directly after implant placement. 5-year results comparing delayed and immediate loading protocols in the anterior region show similar results. However, outcomes of immediate loading in healed posterior implant sites are scarce. Objective: The primary objective is to compare radiographical parameters of immediate loading with delayed loading of single posterior tooth implants. Secondary objectives are clinical outcomes and satisfaction. Study design: The study is designed as a randomized controlled trial. Study population: Adult patients with a missing molar in the maxilla or mandible are included in this study. Intervention: All participants will receive a dental implant in the posterior maxilla or mandible. The test group will receive immediate loading with a non-occluding temporary restoration, while the control group will receive delayed loading after a 3 months healing period. Both groups will receive a definitive zirconia restoration 3 months after implant placement. The follow-up consists of radiographical and clinical evaluation, 1 and 12 months after placing the final restoration.
Study objective
There is no difference in radiographic parameters of immediate loading and delayed loading of single posterior tooth implants in healed sites.
Study design
T1: 1 month after placement of the final restoration, T12: 12 months after placement of the final restoration.
Intervention
Test group: immediate loading. Control group: delayed loading.
Inclusion criteria
• One missing tooth (for at least 3 months), being a first or second molar in the maxilla or mandible;
• Sufficient healthy and vital bone to insert a dental implant with a diameter of 4.2 mm and a length of at least 8 mm;
• The implant site must be free from infection;
• Adequate oral hygiene (modified plaque index and modified sulcus bleeding index);
• Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic restoration;
• The patient is capable of understanding and giving informed consent.
Exclusion criteria
• Medical and general contraindications for the surgical procedures;
• Presence of an active and uncontrolled periodontal disease;
• Bruxism;
• Currently has smoking habits, or stopped smoking less than 3 months ago;
• A history of local radiotherapy to the head and neck region.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8893 |
| Other | METc UMCG : METc 2020/671 |