Dental Implant FailedNCT05754970
Clinical, Prospective, Non-profit, Non-pharmacological Study on Geass Healing Abutment: Microbiological, Histological, and Immuno-histochemical Evaluation.
A study testing laser treated in people with Dental Implant Failed, run by G. d'Annunzio University at 1 site in Italy.
Trial summary
The health of peri-implant soft tissues is important for the long-term success rate of dental implants and the surface topography is pivotal in influencing it. Thus, the aim of this study was to evaluate, in human patients, the inflammatory mucosal microenvironment in the tissue surrounding a new, nanoscale… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed
- What is being tested?
- laser treated
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2018to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between 18 and 75 years
- Patients with no systemic and/or oral health disease
- At least six months of healing after tooth extraction
- Adequate dimension of the attached gingiva (>2 mm) or keratinized tissue at the site selected and adequate residual bone crest
Who cannot join
- - Patients with poor oral hygiene
- Plaque score (PS) and bleeding on probing (BOP) more than 25%
- Patients with active periodontal disease
- Insufficient bone thickness for implant insertion and bone augmentation procedures
- patients who necessitate immediate implant loading protocols
- Uncontrolled diabetes mellitus
- Immune diseases
- Patients who smoke more than 10 cig/die
Trial locations and contacts
1 site in 1 country.
About this study
The health of peri-implant soft tissues is important for the long-term success rate of dental implants and the surface topography is pivotal in influencing it. Thus, the aim of this study was to evaluate, in human patients, the inflammatory mucosal microenvironment in the tissue surrounding a new, nanoscale, laser-treated healing abutment characterized by engineered nanopores versus a standard machined-surface.
The prospective clinical study will evaluate the effect of the presence of a laser-etched surface in the coronal portion of healing stumps in forming the coronal seal and reducing the accumulation of bacterial plaque around it. The screws will serve as their own control group since they have both a laser-etched and a smooth portion.
Read more
Primary objective:
To evaluate the adhesion of fibroblastic cells from the peri-implant mucosa on the surface of the healing stump through scanning electron microscope analysis, expressed in terms of the area covered by the cells.
Secondary objectives:
To evaluate the amount of bacterial adhesion around healing stumps with a laser-etched and smooth altered surface through scanning electron microscope analysis, expressed in terms of the area covered by the cells.
To evaluate the presence of hemidesmosomal structures through the expression of α-6 and β-4 integrins.
To evaluate bacterial adhesion on healing screws. To evaluate the healing of peri-implant soft tissues through clinical indices, such as Plaque Index and Gingival Index.
The healing period was 12 ± 4 weeks (T1) before the second surgical procedure, during which all healing abutments were placed. To prevent allocation bias among patients, each healing abutment was designed with two surfaces that alternated between laser-treated/machined and ma-chined/laser-treated. The experimental healing abutment was removed after 30 ± 7 days, which coincided with the soft tissue biopsy.
- Conditions
- Dental Implant Failed
- Being tested
- laser treated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser treatedProcedure or surgery
The second surgical stage was done after a healing period 12 ± 4 weeks (T1) where all the healing abutments were placed. Each healing abutment had repeated the two surfaces as twice follows: laser-treated/machined/ laser-treated/machined. Experimental healing abutment was removed after 30 ± 7 days, the same time as the soft tissue biopsy.
After the healing period (30 ± 7 days), before starting with the prosthetic restoration of the fixtures, an impression was taken of the small-diameter Has, and circular sections (diameter 5 mm) soft tissues around them were retrieved for analysis.
| Study group | Role | What they receive |
|---|---|---|
| laser/machined | Experimental | on the same customized healing abutment laser-treated/machined surface treatments were repeated with the following order: Laser treated/machined/laser treated/machined. This order was performed to eliminate the bias of the different surface allocation on patients. Receives: Procedure: laser treated |
What is being measured
The primary outcome is the main question the study is designed to answer.
soft tissue adhesion
To evaluate the adhesion of fibroblastic cells from the peri-implant mucosa on the surface of the healing stump through scanning electron microscope analysis, expressed in terms of the area covered by the cells.
Measured: After a healing period of 12 ± 4 weeks, during the second surgical phase
Secondary outcomes (1)
bacterial adhesion
To evaluate the amount of bacterial adhesion around healing stumps with a laser-etched and smooth altered surface through scanning electron microscope analysis, expressed in terms of the area covered by the cells.
Measured: After a healing period of 12 ± 4 weeks, during the second surgical phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start1 Nov 2018
- Primary completion1 Feb 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental Implant FailedStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- To prevent allocation bias among patients, each healing abutment was designed with two surfaces that alternated between laser-treated/machined and ma-chined/laser-treated. The experimental healing abutment was removed after 30 ± 7 days, which coincided with the soft tissue biopsy.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Paolantonio, G. d'Annunzio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754970
- Sponsor's protocol ID
- 2218102018
- Status last verified
- Feb 2023
- First submitted
- 22 Feb 2023
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Belloni A, Argentieri G, Orilisi G, Notarstefano V, Giorgini E, D'Addazio G, Orsini G, Caputi S, Sinjari B. New insights on collagen structural organization and spatial distribution around dental implants: a comparison between machined and laser-treated surfaces. J Transl Med. 2024 Jan 31;22(1):120. doi: 10.1186/s12967-024-04906-4.
PubMed 38297308Gaggi G, Di Credico A, D'Addazio G, Ghinassi B, Argentieri G, Caputi S, Di Baldassarre A, Sinjari B. Impact on peri-implant connective tissue of laser treated versus traditional healing abutments: a human clinical trials. BMC Oral Health. 2023 Jun 27;23(1):425. doi: 10.1186/s12903-023-03148-y.
PubMed 37370064
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Prospective, Non-profit, Non-pharmacological Study on Geass Healing Abutment: Microbiological, Histological, and Immuno-histochemical Evaluation.
- ClinicalTrials.gov ID
- NCT05754970
- Acronym / sponsor ID
- 2218102018
- Conditions
- Dental Implant Failed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 6 Mar 2023 (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.
The health of peri-implant soft tissues is important for the long-term success rate of dental implants and the surface topography is pivotal in influencing it. Thus, the aim of this study was to evaluate, in human patients, the inflammatory mucosal microenvironment in the tissue surrounding a new, nanoscale, laser-treated healing abutment characterized by engineered nanopores versus a standard machined-surface.
The prospective clinical study will evaluate the effect of the presence of a laser-etched surface in the coronal portion of healing stumps in forming the coronal seal and reducing the accumulation of bacterial plaque around it. The screws will serve as their own control group since they have both a laser-etched and a smooth portion.
Primary objective:
To evaluate the adhesion of fibroblastic cells from the peri-implant mucosa on the surface of the healing stump through scanning electron microscope analysis, expressed in terms of the area covered by the cells.
Secondary objectives:
To evaluate the amount of bacterial adhesion around healing stumps with a laser-etched and smooth altered surface through scanning electron microscope analysis, expressed in terms of the area covered by the cells.
To evaluate the presence of hemidesmosomal structures through the expression of α-6 and β-4 integrins.
To evaluate bacterial adhesion on healing screws. To evaluate the healing of peri-implant soft tissues through clinical indices, such as Plaque Index and Gingival Index.
The healing period was 12 ± 4 weeks (T1) before the second surgical procedure, during which all healing abutments were placed. To prevent allocation bias among patients, each healing abutment was designed with two surfaces that alternated between laser-treated/machined and ma-chined/laser-treated. The experimental healing abutment was removed after 30 ± 7 days, which coincided with the soft tissue biopsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To prevent allocation bias among patients, each healing abutment was designed with two surfaces that alternated between laser-treated/machined and ma-chined/laser-treated. The experimental healing abutment was removed after 30 ± 7 days, which coincided with the soft tissue biopsy.
| Arm | Type | Receives |
|---|---|---|
| laser/machined | Experimental | Procedure: laser treatedon the same customized healing abutment laser-treated/machined surface treatments were repeated with the following order: Laser treated/machined/laser treated/machined. This order was performed to eliminate the bias of the different surface allocation on patients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients between 18 and 75 years
- Patients with no systemic and/or oral health disease
- At least six months of healing after tooth extraction
- Adequate dimension of the attached gingiva (>2 mm) or keratinized tissue at the site selected and adequate residual bone crest
Key exclusion criteria (8 listed)
- - Patients with poor oral hygiene
- Plaque score (PS) and bleeding on probing (BOP) more than 25%
- Patients with active periodontal disease
- Insufficient bone thickness for implant insertion and bone augmentation procedures
- patients who necessitate immediate implant loading protocols
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 |
|---|---|---|
| laser treatedThe second surgical stage was done after a healing period 12 ± 4 weeks (T1) where all the healing abutments were placed. Each healing abutment had repeated the two surfaces as twice follows: laser-treated/machined/ laser-treated/machined. Experimental healing abutment was removed after 30 ± 7 days, the same time as the soft tissue biopsy. After the healing period (30 ± 7 days), before starting with the prosthetic restoration of the fixtures, an impression was taken of the small-diameter Has, and circular sections (diameter 5 mm) soft tissues around them were retrieved for analysis. | Procedure or surgery | laser/machined |
Primary outcome
soft tissue adhesion
Time frame: After a healing period of 12 ± 4 weeks, during the second surgical phase
To evaluate the adhesion of fibroblastic cells from the peri-implant mucosa on the surface of the healing stump through scanning electron microscope analysis, expressed in terms of the area covered by the cells.
1 secondary outcome
bacterial adhesion
Time frame: After a healing period of 12 ± 4 weeks, during the second surgical phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Derived from this study: PubMed 38297308Belloni A, Argentieri G, Orilisi G, Notarstefano V, Giorgini E, D'Addazio G, Orsini G, Caputi S, Sinjari B. New insights on collagen structural organization and spatial distribution around dental implants: a comparison between machined and laser-treated surfaces. J Transl Med. 2024 Jan 31;22(1):120. doi: 10.1186/s12967-024-04906-4.
- Derived from this study: PubMed 37370064Gaggi G, Di Credico A, D'Addazio G, Ghinassi B, Argentieri G, Caputi S, Di Baldassarre A, Sinjari B. Impact on peri-implant connective tissue of laser treated versus traditional healing abutments: a human clinical trials. BMC Oral Health. 2023 Jun 27;23(1):425. doi: 10.1186/s12903-023-03148-y.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser treated in people with Dental Implant Failed, run by G. d'Annunzio University at 1 site in Italy.
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 4 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: finished, as of the sponsor's last update on 6 Mar 2023. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
soft tissue adhesion (time frame: After a healing period of 12 ± 4 weeks, during the second surgical phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05754970, which also lists 2 linked publications.
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 6 Mar 2023.