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Submerged Vs Non-Submerged Guided Bone Regeneration Simultaneous to Implant Placement.

ConditionsGuided Bone RegenerationDental ImplantSubmerged RegenerationBone Atrophy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitat Internacional de Catalunya

About this trial

Dental implants are worldwide recognized one of the best manners to replace lost or hopeless prognosis teeth. There are different variables that creates proper conditions for long-term prognosis of implant treatments.

Implant position and surrounding bone around them, have been described in scientific literature to be key factors in the longevity of those treatments.

It has to be defined the \"critical bone thickness\" around implants. It basically means that implants has to be completely surrounded by bone, that will serve as protection. If the implants are not surrounded by bone, procedures as guided bone regeneration may be performed.

Those procedures can be executed before or simultaneously during the implant placement. In the standard procedure, the simultaneous guided bone regeneration during implant placement requires to leave the implant and the regeneration healing below the gingiva, needing a second surgery for accesing to those implants.

In this randomized controlled trial the hypothesis is to discover if not submerging this regenerations may show the same results than submerged ones.

For that, the objective is to study the different variables around these regeneration to evaluate the performance of non-submerged protocol.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

• Men and women over 18 years old.

Patients requiring single-unit implant restoration in any tooth site of the maxilla and mandible in between teeth.

Anticipation of a peri-implant buccal osseous dehiscence by means of a CT imaging (cone-beam computed tomography, CBCT) with a maximum vertical dimension height (VDH) of 50%.

Presence of adjacent teeth.

Disqualifiers

Implant surgery requiring sinus lift procedure.

Previous bone augmentation at the implant site.

Active periodontal disease.

Acute infection at the rehabilitation site.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Guided Bone Regeneration (Submerged)

    Procedure/Surgery

    Guided Bone Regeneration by means of bone xenograft and collagen membrane (submerged approach)

  • Guided Bone Regeneration (Non-submerged)

    Procedure/Surgery

    Guided Bone Regeneration by means of bone xenograft and collagen membrane (Non submerged Approach)

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Control Group (Submerged Approach)Active comparator 1 intervention
Group B: Test Group (Non-Submerged Approach)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Vertical bone dimensional changes

Comparison between CBCT images. Vertical bone changes in mm from initial CBCT to 12 months CBCT will be asessed.

Time frame
0-12months

Secondary outcomes

1

Horizontal bone dimensional changes

Comparison between CBCT images

Time frame
0-12 months
2

Buccal Bone thickness (Dehiscence resolution)

Comparison between CBCT images

Time frame
0-12 months
3

Marginal Bone Loss (MBL)

Comparison between 2d xrays

Time frame
0-12 months
4

Peri-implant clinical parameters

Clinical variables

Time frame
0-12 months

Other outcomes

Sponsors and contacts

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

Universitat Internacional de Catalunya

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: