Soft Tissue Integration of Different Abutment Surfaces

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

Status: Completed

Conditions: Edentulous Alveolar Ridge; Soft Tissue Healing

Treatments: Procedure: abutment insertion; Procedure: Argon plasma pre-treated abutment insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT05821673

DD-02

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 4 patient groups, including a placebo group

abutments with machine surface

Placebo Comparator group

Description:

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

Treatment:

Procedure: abutment insertion

Procedure: Argon plasma pre-treated abutment insertion

abutments with rough Ultrathin Threaded Microsurface

Placebo Comparator group

Description:

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

Treatment:

Procedure: abutment insertion

Procedure: Argon plasma pre-treated abutment insertion

argon plasma pre-treated (PT) abutments

Experimental group

Description:

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

Treatment:

Procedure: Argon plasma pre-treated abutment insertion

non treated abutments

Placebo Comparator group

Description:

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

Treatment:

Procedure: abutment insertion