Actively Recruiting
Effects of Splinted or Non-splinted Single-unit Crowns on Bone Level Changes Around Posterior Jaw Implants
Led by Peking University · Updated on 2022-04-26
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
P
Peking University
Lead Sponsor
D
Dentsply Sirona Implants and Consumables
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of splinted versus non-splinted single-unit crowns on the bone levels around dental implants in patients who have lost posterior teeth in both sides of the upper or lower jaw for more than six months. The study aims to understand whether splinted crowns are suitable when placed next to multiple implants, as splinting may affect implant function. The trial includes at least 20 patients in generally good health who need implant-supported restorations in the posterior maxilla or mandible. Participants will receive implant-supported prosthetic restorations on both sides of the jaw, with one side receiving splinted crowns and the other side non-splinted single crowns. The assignment of each side to the splinted or non-splinted group is randomized using a computer-generated table. All implants are placed by the same qualified surgeon, and prosthetic procedures are done by an experienced prosthodontist. During the three-year follow-up, participants will undergo clinical evaluations and radiographic analyses performed by a blinded oral and maxillofacial radiologist. The study will measure changes in marginal bone levels, probing pocket depth, plaque, and bleeding on probing around the implants. Participants are monitored for up to 36 months after prosthetic loading to assess the outcomes and implant health.
CONDITIONS
Brief Title
Effects of Splinted or Non-splinted Single-unit Crowns on Marginal Bone-level Alterations Around Implants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be in generally good health.
- Need fixed implant-supported prostheses in both posterior maxillae or mandibles with at least two adjacent teeth missing on both sides from 1st premolar to 2nd molar.
- Able to be followed up for 36 months after prosthetic loading.
- Have a wide ridge of bone allowing insertion of a 4mm platform implant and at least 8mm of vertical bone height.
- Same posterior teeth lost on both sides for more than 6 months.
You will not qualify if you...
- Insufficient bone ridge for a 4mm platform implant and 8mm vertical bone height.
- Need for pre-surgical bone or soft tissue augmentation in planned implant area.
- Uncontrolled oral cavity diseases.
- History of radiation therapy in head and neck region.
- History of chemotherapy within 5 years before surgery.
- Systemic or local diseases compromising healing or osseointegration.
- Uncontrolled diabetes mellitus.
- Use of corticosteroids or other medications affecting healing or osseointegration.
- Smoking more than 10 cigarettes per day.
- Present alcohol or drug abuse.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months after prosthetic loading
Participants receive implant-supported prosthetic procedures with either splinted or non-splinted single-unit crowns on implants in the posterior jaw.
Regular clinical evaluations and radiographic analyses during treatment period
Duration - Up to 3 years
Participants are monitored for marginal bone level changes, probing pocket depth, plaque, and bleeding on probing around the implants.
Periodic visits for clinical and radiographic assessments up to 3 years
Trial Site Locations
Total: 1 location
1
Department of Prosthodontics, Peking University School and Hospital of Stomatology
Beijing, Beijing Municipality, China, 100081
Actively Recruiting
Research Team
J
Jianzhang Liu, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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