Guided Bone RegenerationNCT06695338
Submerged Vs Non-Submerged Guided Bone Regeneration Simultaneous to Implant Placement.
A study testing Guided Bone Regeneration (Submerged) and Guided Bone Regeneration (Non-submerged) in people with Guided Bone Regeneration and Dental Implant, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Guided Bone Regeneration, Dental Implant, Submerged Regeneration
- What is being tested?
- Guided Bone Regeneration (Submerged) and Guided Bone Regeneration (Non-submerged)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 15 Dec 2024to 6 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Uic Barcelona
Barcelona
Germán Pardo Perl, +34 630083315, germanpardo@uic.es
About this study
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.
Read more
It has to be defined the \&amp;#34;critical bone thickness\&amp;#34; 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.
- Being tested
- Guided Bone Regeneration (Submerged), Guided Bone Regeneration (Non-submerged)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Bone Regeneration (Submerged)Procedure or surgery
Guided Bone Regeneration by means of bone xenograft and collagen membrane (submerged approach)
Guided Bone Regeneration (Non-submerged)Procedure or surgery
Guided Bone Regeneration by means of bone xenograft and collagen membrane (Non submerged Approach)
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Submerged Approach) | Active comparator | 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. Receives: Procedure: Guided Bone Regeneration (Submerged) |
| Test Group (Non-Submerged Approach) | Experimental | 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. Receives: Procedure: Guided Bone Regeneration (Non-submerged) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical bone dimensional changes
Comparison between CBCT images. Vertical bone changes in mm from initial CBCT to 12 months CBCT will be asessed.
Measured: 0-12months
Secondary outcomes (6)
Horizontal bone dimensional changes
Comparison between CBCT images
Measured: 0-12 months
Buccal Bone thickness (Dehiscence resolution)
Comparison between CBCT images
Measured: 0-12 months
Marginal Bone Loss (MBL)
Comparison between 2d xrays
Measured: 0-12 months
Peri-implant clinical parameters
Clinical variables
Measured: 0-12 months
Volumetric parameters
Comparison between STL's models
Measured: 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)
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start15 Dec 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion6 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guided Bone RegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Germán E. Pardo Perl, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695338
- Sponsor's protocol ID
- PER-ECL-2021-10
- Status last verified
- Nov 2024
- First submitted
- 29 Sep 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Submerged Vs Non-Submerged Guided Bone Regeneration Simultaneous to Implant Placement.
- ClinicalTrials.gov ID
- NCT06695338
- Acronym / sponsor ID
- PER-ECL-2021-10
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 6 Jun 2026 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 \&amp;#34;critical bone thickness\&amp;#34; 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (Submerged Approach) | Active comparator | Procedure: Guided Bone Regeneration (Submerged)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. |
| Test Group (Non-Submerged Approach) | Experimental | Procedure: Guided Bone Regeneration (Non-submerged)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- • Men and women over 18 years old.
Key exclusion criteria (8 listed)
- Implant surgery requiring sinus lift procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Bone Regeneration (Submerged)Guided Bone Regeneration by means of bone xenograft and collagen membrane (submerged approach) | Procedure or surgery | Control Group (Submerged Approach) |
| Guided Bone Regeneration (Non-submerged)Guided Bone Regeneration by means of bone xenograft and collagen membrane (Non submerged Approach) | Procedure or surgery | Test Group (Non-Submerged Approach) |
Primary outcome
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.
6 secondary outcomes
Horizontal bone dimensional changes
Time frame: 0-12 months
Buccal Bone thickness (Dehiscence resolution)
Time frame: 0-12 months
Marginal Bone Loss (MBL)
Time frame: 0-12 months
Peri-implant clinical parameters
Time frame: 0-12 months
Volumetric parameters
Time frame: 0-12 months
PROMs
Time frame: 0-12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
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Impact of Gingival Phenotype on Guided Bone Regeneration in the Maxillary Anterior Region
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Evaluation of Bone Regeneration Outcomes Following Guided Bone Regeneration in the Anterior Maxillary Region
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Long-Term Stability of Soft and Hard Tissues After Guided Bone Regeneration in the Maxillary Anterior Region
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Bone Regeneration (Submerged) and Guided Bone Regeneration (Non-submerged) in people with Guided Bone Regeneration and Dental Implant, run by Universitat Internacional de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Germán Pardo Perl, DDS, MSc (+34630083315, Germanpardo@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertical bone dimensional changes (time frame: 0-12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.