Back to resultsSoft Tissue Integration of Different Abutment Surfaces
Primary Purpose
Edentulous Alveolar Ridge, Soft Tissue Healing
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Argon plasma pre-treated abutment insertion
abutment insertion
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous Alveolar Ridge
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Sites / Locations
- Studio Odont.Associato Dr.P.Cicchese E L.Canullo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
abutments with machine surface
abutments with rough Ultrathin Threaded Microsurface
argon plasma pre-treated (PT) abutments
non treated abutments
Arm Description
abutments with machine surface characterized by circular micro-threads with a furrow of less than 2 um
abutments with rough Ultrathin Threaded Microsurface with a triangular contour tread with a pitch of 50 μm
abutments with rough Ultrathin Threaded Microsurface and abutments with machine surface were pretreated with Argon Plasma
abutments with rough Ultrathin Threaded Microsurface and abutments with machine surface without Argon Plasma pretreatment.
Outcomes
Primary Outcome Measures
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.
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05821673
First Posted
April 7, 2023
Last Updated
April 7, 2023
Sponsor
Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
1. Study Identification
Unique Protocol Identification Number
NCT05821673
Brief Title
Soft Tissue Integration of Different Abutment Surfaces
Official Title
Effect of Argon Plasma Abutment Activation on Soft Tissue Healing: RCT Study With Histological Assessment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
December 18, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Alveolar Ridge, Soft Tissue Healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
the histologist was blinded
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
abutments with machine surface
Arm Type
Placebo Comparator
Arm Description
abutments with machine surface characterized by circular micro-threads with a furrow of less than 2 um
Arm Title
abutments with rough Ultrathin Threaded Microsurface
Arm Type
Placebo Comparator
Arm Description
abutments with rough Ultrathin Threaded Microsurface with a triangular contour tread with a pitch of 50 μm
Arm Title
argon plasma pre-treated (PT) abutments
Arm Type
Experimental
Arm Description
abutments with rough Ultrathin Threaded Microsurface and abutments with machine surface were pretreated with Argon Plasma
Arm Title
non treated abutments
Arm Type
Placebo Comparator
Arm Description
abutments with rough Ultrathin Threaded Microsurface and abutments with machine surface without Argon Plasma pretreatment.
Intervention Type
Procedure
Intervention Name(s)
Argon plasma pre-treated abutment insertion
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
abutment insertion
Intervention Description
the abutments assigned to the control group were screwed onto the implants without receiving argon plasma pretreatment
Primary Outcome Measure Information:
Title
Histological and immunohistochemical assessment
Description
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.
Time Frame
2 months after abutment placement
Title
Plaque index (PI)
Description
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.
Time Frame
2 months after abutment placement
Title
Bleeding on probing (BoP)
Description
BoP scores were recorded in 6 points around each abutment, averaged, and expressed in %.BoP was used as a dichotomous variable
Time Frame
2 months after abutment placement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Facility Information:
Facility Name
Studio Odont.Associato Dr.P.Cicchese E L.Canullo
City
Rome
State/Province
Italy/Rome
ZIP/Postal Code
00198
Country
Italy
12. IPD Sharing Statement
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Soft Tissue Integration of Different Abutment Surfaces
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