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NCT Number: NCT02880891

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Prosthodontics, Peking University School and Hospital of Stomatology

Beijing, Beijing Municipality, 100081, China

Location status: Recruiting

Location contact

yongsheng zhou, PHD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients would be in general good health.
  • 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).
  • The patients could be followed-up for 36 months after prosthetic loading
  • 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.
  • The same posterior teeth had lost on both sides for more than 6 months.

Exclusion criteria

  • 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.
  • Current need for pre-surgical bone or soft tissue augmentation in the planned implant area;
  • Uncontrolled pathologic processes in the oral cavity;
  • History of radiation therapy in the head and neck region;
  • History of chemotherapy within 5 years prior to surgery;
  • Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration;
  • Uncontrolled diabetes mellitus;
  • Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration;
  • Smoking more than 10 cigarettes/day;
  • Present alcohol and/or drug abuse

Treatment and study plan

prothetic procedure

Procedure

splinted crown

Other names: crown on the implants

Primary outcomes

  1. Marginal Bone Levels (MBL)

    Time frame: three years

    marginal bone level around the implants using CT scan

  2. Probing Pocket Depth (PPD)

    Time frame: three years

    Probing Pocket Depth (PPD) for the implants

  3. Plaque (implant level)

    Time frame: three years

    Plaque (implant level) of the crowns

  4. Bleeding on Probing (Implant level)

    Time frame: three years

    Bleeding on Probing of the crowns

Study contacts

Contact information is provided by the study sponsor or research team.

Jianzhang Liu, Doctor

CONTACT

[email protected]

+8613661174609

Sponsors and collaborators

Lead sponsor

Peking University

Other

Collaborators

  • Dentsply Sirona Implants and Consumables

Registry information

Official study title

School and Hospital of Somatology, Peking University

Important dates

Study start
2016
Primary completion
2024
Study completion
2026
First posted
Aug 26, 2016
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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