Edentulous Alveolar RidgeNCT05821673
Soft Tissue Integration of Different Abutment Surfaces
A study testing Argon plasma pre-treated abutment insertion and abutment insertion in people with Edentulous Alveolar Ridge and Soft Tissue Healing, run by Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo at 1 site in Italy.
Trial summary
Objective of the present study was to assess the peri-implant soft tissue profiles between argon plasma pre-treated (PT) and non-treated (NPT) abutments by comparing clinical and histological parameters 2 months after abutment placement. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge, Soft Tissue Healing
- What is being tested?
- Argon plasma pre-treated abutment insertion and abutment insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jun 2021to 30 Jun 2022
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient requiring implant supported restoration.
- Residual alveolar bone width of edentulous jaw of > 8mm.
- Keratinized mucosa width of >6mm
- Males and females between 18-80 years old
- Patients with healthy periodontal conditions (Treated periodontitis, PI<25%, BoP<25%)
- Patients that are willing to sign an informed consent and participate in a clinical study
- Generally fit and healthy and able to undergo oral surgical procedures under local anesthesia.
- Teeth at the surgical site which required removal were extracted a minimum of 12 weeks prior to sinus floor elevation
Who cannot join
- Patients who smoke over 10 cigarettes/day
- Pregnancy (confirmed by verbal inquiry)
- Chronic systemic pathologies (e.g. diabetes) and neoplastic of the Oro-Facial District 4.
- Patients taking bisphosphonates
- Any sites where an implant already failed sites
- Untreated Periodontitis
Show all 13Show fewer
- Dental sites with acute infections
- Chronic inflammatory diseases of the oral cavity
- Autoimmune diseases (cortisone intake)
- Allergy declared to one or more medicaments to be used during treatment
- Alcoholics patients and/or drug addicts.
- History or malignant tumours of the maxillary sinus
- History of local radiation therapy
Trial locations and contacts
1 site in 1 country.
Italy1 site
Studio Odont.Associato Dr.P.Cicchese E L.Canullo
Rome, Italy/Rome, 00198
About this study
Official title: Effect of Argon Plasma Abutment Activation on Soft Tissue Healing: RCT Study With Histological Assessment
Objective of the present study was to assess the peri-implant soft tissue profiles between argon plasma pre-treated (PT) and non-treated (NPT) abutments by comparing clinical and histological parameters 2 months after abutment placement.
Read the detailed description
Patients that need implant supported restoration were recruited for this study. At baseline a specific abutment was screwed at 20 N.Two months following healing abutment placement clinical measurements were evaluated.
Endopoints of the study:
Histological outcomes at 2 using traditional histological staining (ematossilin/eosin) Immunohistological outcomes at 2 using different stainings. Postoperative complications. Comparison between the histological outcomes and the preoperative clinical evaluation of the sites
- Conditions
- Edentulous Alveolar Ridge, Soft Tissue Healing
- Being tested
- Argon plasma pre-treated abutment insertion, abutment insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argon plasma pre-treated abutment insertionProcedure or surgery
abutments allocated to the test group were placed in an Argon plasma reactor (Diener Electronic GmbH, Jettingen, Germany) for decontamination and activation. In order to restrict any post-treatment contamination; abutments were inserted immediately after the end of the plasma process. The reactor was set at 75 W of power and -10 MPa of pressure for 12 min.
abutment insertionProcedure or surgery
the abutments assigned to the control group were screwed onto the implants without receiving argon plasma pretreatment
| Study group | Role | What they receive |
|---|---|---|
| abutments with machine surface | Placebo comparator | abutments with machine surface characterized by circular micro-threads with a furrow of less than 2 um Receives: Procedure: Argon plasma pre-treated abutment insertion; Procedure: abutment insertion |
| abutments with rough Ultrathin Threaded Microsurface | Placebo comparator | abutments with rough Ultrathin Threaded Microsurface with a triangular contour tread with a pitch of 50 μm Receives: Procedure: Argon plasma pre-treated abutment insertion; Procedure: abutment insertion |
| argon plasma pre-treated (PT) abutments | Experimental | abutments with rough Ultrathin Threaded Microsurface and abutments with machine surface were pretreated with Argon Plasma Receives: Procedure: Argon plasma pre-treated abutment insertion |
| non treated abutments | Placebo comparator | abutments with rough Ultrathin Threaded Microsurface and abutments with machine surface without Argon Plasma pretreatment. Receives: Procedure: abutment insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological and immunohistochemical assessment
soft peri-implant tissues and abutment were harvested and histologically processedSpecialized stainings (hematoxylin eosin and picrocirious red) coupled with immunohistochemistry (vimentin, collagen, and CK10) were performed to assess soft tissue inflammation and healing, as well as the collagen content keratinization.
Measured: 2 months after abutment placement
Plaque index (PI)
PI scores were recorded in 6 points around each abutment, averaged, and expressed in %. PI was evaluated with a score of 0,1,2, 3 depending on the amount of plaque at each site.
Measured: 2 months after abutment placement
Bleeding on probing (BoP)
BoP scores were recorded in 6 points around each abutment, averaged, and expressed in %.BoP was used as a dichotomous variable
Measured: 2 months after abutment placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start21 Jun 2021
- Primary completion18 Dec 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies 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
- Model description
- Participants received either abutments with machine surface characterized by circular micro-threads with a furrow of less than 2 um (surface roughness: Ra=0.2 and Sa=0.11) or abutments with rough Ultrathin Threaded Microsurface with a triangular contour tread with a pitch of 50 μm (surface roughness: Ra=0.62 and Sa=0.60) abutments allocated to the test group were placed in an Argon plasma reactor (Diener Electronic GmbH, Jettingen, Germany) for decontamination and activation. in control group were allocated argon plasma non-treated abutmentsParticipants underwent 2-level randomization for allocation of abutments with different surface configurations and experimental treatment using permuted block technique to limit any selection bias. Allocation concealment was preserved by sealing the tested abutments in sterile envelopes sealed in opaque sleeves opened at the time of the second surgical step.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Canullo, Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821673
- Sponsor's protocol ID
- DD-02
- Status last verified
- Apr 2023
- First submitted
- 7 Apr 2023
- Last updated
- 20 Apr 2023
- 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 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Argon Plasma Abutment Activation on Soft Tissue Healing: RCT Study With Histological Assessment
- ClinicalTrials.gov ID
- NCT05821673
- Acronym / sponsor ID
- DD-02
- Conditions
- Edentulous Alveolar Ridge, Soft Tissue Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Studio Odontoiatrico Associato Dr. P. Cicchese e L. CanulloUniversity, hospital or other
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 18 Dec 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 20 Apr 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.
Objective of the present study was to assess the peri-implant soft tissue profiles between argon plasma pre-treated (PT) and non-treated (NPT) abutments by comparing clinical and histological parameters 2 months after abutment placement.
Detailed description
Patients that need implant supported restoration were recruited for this study. At baseline a specific abutment was screwed at 20 N.Two months following healing abutment placement clinical measurements were evaluated.
Endopoints of the study:
Histological outcomes at 2 using traditional histological staining (ematossilin/eosin) Immunohistological outcomes at 2 using different stainings. Postoperative complications. Comparison between the histological outcomes and the preoperative clinical evaluation of the sites
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants received either abutments with machine surface characterized by circular micro-threads with a furrow of less than 2 um (surface roughness: Ra=0.2 and Sa=0.11) or abutments with rough Ultrathin Threaded Microsurface with a triangular contour tread with a pitch of 50 μm (surface roughness: Ra=0.62 and Sa=0.60) abutments allocated to the test group were placed in an Argon plasma reactor (Diener Electronic GmbH, Jettingen, Germany) for decontamination and activation. in control group were allocated argon plasma non-treated abutmentsParticipants underwent 2-level randomization for allocation of abutments with different surface configurations and experimental treatment using permuted block technique to limit any selection bias. Allocation concealment was preserved by sealing the tested abutments in sterile envelopes sealed in opaque sleeves opened at the time of the second surgical step.
| Arm | Type | Receives |
|---|---|---|
| abutments with machine surface | Placebo comparator | Procedure: Argon plasma pre-treated abutment insertion, Procedure: abutment insertionabutments with machine surface characterized by circular micro-threads with a furrow of less than 2 um |
| abutments with rough Ultrathin Threaded Microsurface | Placebo comparator | Procedure: Argon plasma pre-treated abutment insertion, Procedure: abutment insertionabutments with rough Ultrathin Threaded Microsurface with a triangular contour tread with a pitch of 50 μm |
| argon plasma pre-treated (PT) abutments | Experimental | Procedure: Argon plasma pre-treated abutment insertionabutments with rough Ultrathin Threaded Microsurface and abutments with machine surface were pretreated with Argon Plasma |
| non treated abutments | Placebo comparator | Procedure: abutment insertionabutments with rough Ultrathin Threaded Microsurface and abutments with machine surface without Argon Plasma pretreatment. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient requiring implant supported restoration.
- Residual alveolar bone width of edentulous jaw of > 8mm.
- Keratinized mucosa width of >6mm
- Males and females between 18-80 years old
- Patients with healthy periodontal conditions (Treated periodontitis, PI<25%, BoP<25%)
Key exclusion criteria (13 listed)
- Patients who smoke over 10 cigarettes/day
- Pregnancy (confirmed by verbal inquiry)
- Chronic systemic pathologies (e.g. diabetes) and neoplastic of the Oro-Facial District 4.
- Patients taking bisphosphonates
- Any sites where an implant already failed sites
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 |
|---|---|---|
| Argon plasma pre-treated abutment insertionabutments allocated to the test group were placed in an Argon plasma reactor (Diener Electronic GmbH, Jettingen, Germany) for decontamination and activation. In order to restrict any post-treatment contamination; abutments were inserted immediately after the end of the plasma process. The reactor was set at 75 W of power and -10 MPa of pressure for 12 min. | Procedure or surgery | abutments with machine surface, abutments with rough Ultrathin Threaded Microsurface, argon plasma pre-treated (PT) abutments |
| abutment insertionthe abutments assigned to the control group were screwed onto the implants without receiving argon plasma pretreatment | Procedure or surgery | abutments with machine surface, abutments with rough Ultrathin Threaded Microsurface, non treated abutments |
Primary outcome
Histological and immunohistochemical assessment
Time frame: 2 months after abutment placement
soft peri-implant tissues and abutment were harvested and histologically processedSpecialized stainings (hematoxylin eosin and picrocirious red) coupled with immunohistochemistry (vimentin, collagen, and CK10) were performed to assess soft tissue inflammation and healing, as well as the collagen content keratinization.
Plaque index (PI)
Time frame: 2 months after abutment placement
PI scores were recorded in 6 points around each abutment, averaged, and expressed in %. PI was evaluated with a score of 0,1,2, 3 depending on the amount of plaque at each site.
Bleeding on probing (BoP)
Time frame: 2 months after abutment placement
BoP scores were recorded in 6 points around each abutment, averaged, and expressed in %.BoP was used as a dichotomous variable
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 20 Apr 2023.
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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 Argon plasma pre-treated abutment insertion and abutment insertion in people with Edentulous Alveolar Ridge and Soft Tissue Healing, run by Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo 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 8 inclusion and 13 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 20 Apr 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. Some participants in this study may receive a placebo. 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?
Histological and immunohistochemical assessment (time frame: 2 months after abutment placement). The study lists 3 primary outcomes in all. 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 20 Apr 2023.