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NCT Number: NCT06695338

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

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.

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Key information

Conditions

Guided Bone Regeneration Bone Atrophy Dental Implant Submerged Regeneration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • • 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.
  • Presence of antagonist teeth.
  • Minimum primary stability of 25Ncm.
  • Non-smokers or light smokers (< 10 cigarettes per day).
  • Absence of systemic diseases that could influence the outcome of the therapy (i.e., uncontrolled diabetes mellitus, osteoporosis, biphosphonate medication).
  • Tooth extraction performed at least 4 months before implant placement.
  • Good level of oral hygiene (Plaque Index < 25%) (Löe, 1967)
  • Written informed consent signed.
  • Keratinized mucosa of at least 2mm on the buccal and lingual of the implant.

Exclusion criteria

  • Implant surgery requiring sinus lift procedure.
  • Previous bone augmentation at the implant site.
  • Active periodontal disease.
  • Acute infection at the rehabilitation site.
  • Long-term non-steroidal anti-inflammatory drug therapy (3 months).
  • Lactating females or currently pregnancy.
  • Severe cognitive or psychiatric disorders.
  • Unwillingness to return for follow-up examination.

Treatment and study plan

Guided Bone Regeneration (Submerged)

Procedure

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

Guided Bone Regeneration (Non-submerged)

Procedure

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

Primary outcomes

  1. Vertical bone dimensional changes

    Time frame: 0-12months

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

Secondary outcomes

  1. Horizontal bone dimensional changes

    Time frame: 0-12 months

    Comparison between CBCT images

  2. Buccal Bone thickness (Dehiscence resolution)

    Time frame: 0-12 months

    Comparison between CBCT images

  3. Marginal Bone Loss (MBL)

    Time frame: 0-12 months

    Comparison between 2d xrays

  4. Peri-implant clinical parameters

    Time frame: 0-12 months

    Clinical variables

  5. Volumetric parameters

    Time frame: 0-12 months

    Comparison between STL's models

  6. PROMs

    Time frame: 0-12 months

    Patient Related Outcomes. (Overall satisfaction from 1-10, Pain perceived from 1-10, Willingness to repeat in case of need from 1-10)

Study contacts

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

Germán Pardo Perl, DDS, MSc

CONTACT

[email protected]

+34630083315

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2024
Registry last updated
Nov 19, 2024

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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