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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Implant; Guided Bone Regeneration; Bone Atrophy; Submerged Regeneration
• Intervention / Treatment: Procedure: Guided Bone Regeneration (Submerged); Procedure: Guided Bone Regeneration (Non-submerged)

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Germán Pardo Perl, DDS, MSc; Phone Number: +34630083315; Email: Germanpardo@uic.es

Study Locations

• Spain
  • Barcelona, Spain
    • Uic Barcelona
    • Contact: Germán Pardo Perl; Phone Number: +34 630083315; Email: germanpardo@uic.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group (Submerged Approach); Standard/Conventional approach in which guided bone regeneration simultaneous to implant placement is leaved submerged under gingival tissue by suturing looking for first intention healing.	Procedure: Guided Bone Regeneration (Submerged); Guided Bone Regeneration by means of bone xenograft and collagen membrane (submerged approach)
Experimental: Test Group (Non-Submerged Approach); To test approach in which guided bone regeneration simultaneous to implant placement is leaved in a non-submerged manner with second intention healing around an abutment and interproximal suturing.	Procedure: Guided Bone Regeneration (Non-submerged); Guided Bone Regeneration by means of bone xenograft and collagen membrane (Non submerged Approach)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vertical bone dimensional changes	Comparison between CBCT images. Vertical bone changes in mm from initial CBCT to 12 months CBCT will be asessed.	0-12months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Horizontal bone dimensional changes	Comparison between CBCT images	0-12 months
Buccal Bone thickness (Dehiscence resolution)	Comparison between CBCT images	0-12 months
Marginal Bone Loss (MBL)	Comparison between 2d xrays	0-12 months
Peri-implant clinical parameters	Clinical variables	0-12 months
Volumetric parameters	Comparison between STL's models	0-12 months
PROMs	Patient Related Outcomes. (Overall satisfaction from 1-10, Pain perceived from 1-10, Willingness to repeat in case of need from 1-10)	0-12 months

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): June 6, 2026

Study Registration Dates

• First Submitted: September 29, 2024
• First Submitted That Met QC Criteria: November 16, 2024
• First Posted (Estimated): November 19, 2024

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 16, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: PER-ECL-2021-10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No