Health TrialsbyHealthPanel

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

ConditionJaw, Edentulous, Partially
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorPeking University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • prothetic procedure

    Procedure/Surgery

    splinted crown

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: splintedExperimental treatment 1 intervention
Group B: non-splintedNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Marginal Bone Levels (MBL)

marginal bone level around the implants using CT scan

Time frame
three years
2

Probing Pocket Depth (PPD)

Probing Pocket Depth (PPD) for the implants

Time frame
three years
3

Plaque (implant level)

Plaque (implant level) of the crowns

Time frame
three years
4

Bleeding on Probing (Implant level)

Bleeding on Probing of the crowns

Time frame
three years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University

Lead sponsor

Dentsply Sirona Implants and Consumables

Collaborator

Source ClinicalTrials.gov
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