Comparing splinted and non-splinted crowns on dental implants

School and Hospital of Somatology, Peking University

This study is testing whether using splinted or non-splinted crowns on dental implants helps keep the bone levels around the implants healthier for people who have lost nearby teeth.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Peking University (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT02880891 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of splinted versus non-splinted single-unit crowns on marginal bone-level changes around dental implants. It involves 80-100 consecutive implants placed in at least 20 patients who have lost adjacent posterior teeth for more than six months. Patients will be randomly assigned to receive either splinted or non-splinted crowns, and clinical evaluations along with radiographic analyses will be conducted by qualified professionals. The goal is to determine which approach better maintains bone levels around the implants over a follow-up period of 36 months.

Who should consider this trial

Good fit: Ideal candidates are patients in good health needing fixed implant-supported prostheses in the posterior maxilla or mandible with adjacent teeth lost for over six months.

Not a fit: Patients with insufficient bone for implant placement or those requiring pre-surgical augmentation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved dental implant outcomes and better preservation of bone levels for patients receiving crowns.

How similar studies have performed: Previous studies have shown varying success with similar approaches, but this specific comparison of splinted versus non-splinted crowns is relatively novel.

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

Where this trial is running

Beijing, Beijing Municipality

• Department of Prosthodontics, Peking University School and Hospital of Stomatology — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jianzhang Liu, Doctor — Department of Prosthodontics School and Hospital of Stomatology of Peking University
• Study coordinator: Jianzhang Liu, Doctor

Conditions Jaw, Edentulous, Partially