Clinical trial NCT05821673: 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
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Alveolar Ridge
Soft Tissue Healing
Lead sponsor: Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Histological and immunohistochemical assessment
timeFrame: 2 months after abutment placement
measure: Plaque index (PI)
timeFrame: 2 months after abutment placement
measure: Bleeding on probing (BoP)
timeFrame: 2 months after abutment placement
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Studio Odont.Associato Dr.P.Cicchese E L.Canullo
state: Italy/Rome
Study officials:
References: