Soft Tissue Integration of Different Abutment Surfaces

Edentulous Alveolar Ridge Clinical Trial

Official title:

Effect of Argon Plasma Abutment Activation on Soft Tissue Healing: RCT Study With Histological Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05821673
• Other study ID #: DD-02
• Status: Completed
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2023
• Source: Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2022
• Est. primary completion date: December 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Edentulous Alveolar Ridge
• Mouth, Edentulous
• Soft Tissue Healing

Intervention

Procedure:
• 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.
• abutment insertion
the abutments assigned to the control group were screwed onto the implants without receiving argon plasma pretreatment

Locations

Country	Name	City	State
Italy	Studio Odont.Associato Dr.P.Cicchese E L.Canullo	Rome	Italy/Rome

Sponsors (1)

Lead Sponsor	Collaborator
Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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