NCT02880891 Effects of Splinted or Non-splinted Single-unit Crowns on Marginal Bone-level Alterations Around Implants
| NCT ID | NCT02880891 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University |
| Condition | Jaw, Edentulous, Partially |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2016-09 |
| Primary Completion | 2024-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2016-09 with a primary completion date of 2024-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The microthreaded and platform switched implants could control the stress in the suitable range. The splint would disturb the function. So it is necessary to know whether the splinted single-unit crowns is fit for the adjacent multi-implants. Outcome variables: Splinted single-unit crowns on one side implants and non-splinted single-unit crowns on the other side Materials and method: 80-100 consecutive implants in at least 20 patients would be included for implant- supported restorations in the posterior maxilla or mandibular. All patients would be in general good health. For every patient, the same posterior teeth had lost on both sides for more than 6 months. All patients were treated by the same qualified surgeon. Prosthetics procedure would be performed by an experienced prosthodontist. The two sides were allocated to the test or the control group according to the predefined computer-generated randomization table. Clinical evaluations and radiographic analysis were performed by an oral and maxillofacial radiologist who was not aware of the type of Prosthetics technique that was used.
Eligibility Criteria
Inclusion Criteria: 1. All patients would be in general good health. 2. All patients would need for fixed implant-supported prosthesis in the double posterior maxillae or mandibulae (there were at least two corresponding adjacent teeth lost in both sides from the 1st premolar to 2nd molar). 3. The patients could be followed-up for 36 months after prosthetic loading 4. A wide ridge of bone allowing the insertion of a 4mm platform implant and at least 8mm of bone in vertical height would be required. 5. The same posterior teeth had lost on both sides for more than 6 months. Exclusion Criteria: 1. For implant site, a ridge of bone do not allow the insertion of a 4mm platform implant and at least 8mm of bone in vertical height. 2. Current need for pre-surgical bone or soft tissue augmentation in the planned implant area; 3. Uncontrolled pathologic processes in the oral cavity; 4. History of radiation therapy in the head and neck region; 5. History of chemotherapy within 5 years prior to surgery; 6. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration; 7. Uncontrolled diabetes mellitus; 8. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration; 9. Smoking more than 10 cigarettes/day; 10. Present alcohol and/or drug abuse
Contact & Investigator
Jianzhang Liu, Doctor
PRINCIPAL INVESTIGATOR
Department of Prosthodontics School and Hospital of Stomatology of Peking University
Frequently Asked Questions
Who can join the NCT02880891 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Jaw, Edentulous, Partially. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02880891 currently recruiting?
Yes, NCT02880891 is actively recruiting participants. Contact the research team at kqelite@163.com for enrollment information.
Where is the NCT02880891 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT02880891 clinical trial?
NCT02880891 is sponsored by Peking University. The principal investigator is Jianzhang Liu, Doctor at Department of Prosthodontics School and Hospital of Stomatology of Peking University. The trial plans to enroll 20 participants.