Effects of Splinted or Non-splinted Single-unit Crowns on Marginal Bone-level Alterations Around Implants

Jaw, Edentulous, Partially Clinical Trial

Official title:

School and Hospital of Somatology, Peking University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02880891
• Other study ID #: PKUSSIRB-201520029
• Status: Recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: September 2026

Study information

• Verified date: April 2022
• Source: Peking University
• Contact: Jianzhang Liu, Doctor
• Phone: +8613661174609
• Email: kqelite[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2026
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially

Intervention

Procedure:
• prothetic procedure
splinted crown

Locations

Country	Name	City	State
China	Department of Prosthodontics, Peking University School and Hospital of Stomatology	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	Dentsply Sirona Implants

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal Bone Levels (MBL)	marginal bone level around the implants using CT scan	three years
Primary	Probing Pocket Depth (PPD)	Probing Pocket Depth (PPD) for the implants	three years
Primary	Plaque (implant level)	Plaque (implant level) of the crowns	three years
Primary	Bleeding on Probing (Implant level)	Bleeding on Probing of the crowns	three years