Soft Tissue Integration of Different Abutment Surfaces

NCT ID: NCT05821673

Last Updated: 2023-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-21

Study Completion Date

2022-06-30

Brief Summary

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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

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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

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Edentulous Alveolar Ridge Soft Tissue Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
the histologist was blinded

Study Groups

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abutments with machine surface

abutments with machine surface characterized by circular micro-threads with a furrow of less than 2 um

Group Type PLACEBO_COMPARATOR

Argon plasma pre-treated abutment insertion

Intervention Type PROCEDURE

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 insertion

Intervention Type PROCEDURE

the abutments assigned to the control group were screwed onto the implants without receiving argon plasma pretreatment

abutments with rough Ultrathin Threaded Microsurface

abutments with rough Ultrathin Threaded Microsurface with a triangular contour tread with a pitch of 50 μm

Group Type PLACEBO_COMPARATOR

Argon plasma pre-treated abutment insertion

Intervention Type PROCEDURE

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 insertion

Intervention Type PROCEDURE

the abutments assigned to the control group were screwed onto the implants without receiving argon plasma pretreatment

argon plasma pre-treated (PT) abutments

abutments with rough Ultrathin Threaded Microsurface and abutments with machine surface were pretreated with Argon Plasma

Group Type EXPERIMENTAL

Argon plasma pre-treated abutment insertion

Intervention Type PROCEDURE

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.

non treated abutments

abutments with rough Ultrathin Threaded Microsurface and abutments with machine surface without Argon Plasma pretreatment.

Group Type PLACEBO_COMPARATOR

abutment insertion

Intervention Type PROCEDURE

the abutments assigned to the control group were screwed onto the implants without receiving argon plasma pretreatment

Interventions

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Argon plasma pre-treated abutment insertion

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

abutment insertion

the abutments assigned to the control group were screwed onto the implants without receiving argon plasma pretreatment

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patient requiring implant supported restoration.
2. Residual alveolar bone width of edentulous jaw of \> 8mm.
3. Keratinized mucosa width of \>6mm
4. Males and females between 18-80 years old
5. Patients with healthy periodontal conditions (Treated periodontitis, PI\<25%, BoP\<25%)
6. Patients that are willing to sign an informed consent and participate in a clinical study
7. Generally fit and healthy and able to undergo oral surgical procedures under local anesthesia.
8. Teeth at the surgical site which required removal were extracted a minimum of 12 weeks prior to sinus floor elevation

Exclusion Criteria

1. Patients who smoke over 10 cigarettes/day
2. Pregnancy (confirmed by verbal inquiry)
3. Chronic systemic pathologies (e.g. diabetes) and neoplastic of the Oro-Facial District 4.
4. Patients taking bisphosphonates
5. Any sites where an implant already failed sites
6. Untreated Periodontitis
7. Dental sites with acute infections
8. Chronic inflammatory diseases of the oral cavity
9. Autoimmune diseases (cortisone intake)
10. Allergy declared to one or more medicaments to be used during treatment
11. Alcoholics patients and/or drug addicts.
12. History or malignant tumours of the maxillary sinus
13. History of local radiation therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo

OTHER

Sponsor Role lead

Responsible Party

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Luigi Canullo

principal investigator; DDS PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Studio Odont.Associato Dr.P.Cicchese E L.Canullo

Rome, Italy/Rome, Italy

Site Status

Countries

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Italy

Other Identifiers

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DD-02

Identifier Type: -

Identifier Source: org_study_id

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