Soft Tissue Integration of Different Abutment Surfaces

NCT05821673 | Completed

• 1 other identifier: DD-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulous Alveolar Ridge; Soft Tissue Healing

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  2 months after abutment placement

Study Arms (4)

abutments with machine surface

PLACEBO COMPARATOR

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

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

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

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.

Procedure: abutment insertion

Interventions

Argon plasma pre-treated abutment insertion 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.

abutments with machine surface; abutments with rough Ultrathin Threaded Microsurface; argon plasma pre-treated (PT) abutments

abutment insertion PROCEDURE

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

abutments with machine surface; abutments with rough Ultrathin Threaded Microsurface; non treated abutments

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo: lead

Study Sites (1)

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

Rome, Italy/Rome, 00198, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: the histologist was blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator; DDS PHD

Model Details: 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.

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 20, 2023
• Study Start: June 21, 2021
• Primary Completion: December 18, 2021
• Study Completion: June 30, 2022
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

IT (1)