Evaluation of Soft Tissue Response to Titanium Healing Abutments Treated by Erbium: YAG Laser or Plasma Spray

NCT05800795 | Completed DMC

• 1 other identifier: FDASU-RecID021817
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The attachment of peri implant soft tissue to the implant serves as a biological seal that can prevent the development of inflammatory peri-implant diseases. Presence of contaminants has been suggested to be associated with tissue damaging inflammation and titanium wear microparticles were demonstrated to activate osteoclastic action. Er: YAG laser has been extensively investigated clinically for applications for treating periimplantitis either independently or in combination with other techniques, showing favorable outcomes. Plasma spray treatment can decontaminate surfaces without modifying their topography. It is also able to increase the surface energy by obtaining more hydrophilic surfaces, which may increase the capacity of the titanium oxide layer to interact with cells and proteins of surrounding tissue improving cell adhesion to the treated surface.

Conditions

Peri-implant Mucositis

Keywords

healing abutment; plasma spray; Er: YAG laser

Outcome Measures

Primary Outcomes (2)

• histological assessment measuring inflammatory cells count.

  sections of biopsies from peri-implant soft tissue stained with hematoxylin and eosin stain. H\&E stain was used for measuring inflammatory cells count and Masson's Trichrome stains for measuring collagen fibers area fraction.

  two weeks after stage two surgery

• histological assessment measuring collagen fibers area fraction.

  sections of biopsies from peri-implant soft tissue stained with Masson trichrome stain.

  two weeks after stage two surgery

Secondary Outcomes (3)

• scanning electron microscopic analysis

  two weeks after stage two surgery

• clinical assessment measuring plaque index

  two weeks after stage two surgery and after three months

• clinical assessment measuring gingival index

  two weeks after stage two surgery and after three months

Study Arms (3)

laser group

ACTIVE COMPARATOR

Healing abutments have been treated by Er:YAG laser. The laser-machine (with a wavelength of 2.940 nm) was used with settings of 100 mJ/pulse (12.7 J/cm₂) and 10 Hz. The healing abutments' surface was thoroughly decontaminated by the fiber tip in a semicircular contact mode with copious water irrigation.

Device: Er: YAG laser

plasma group

ACTIVE COMPARATOR

Healing abutments have been sprayed with an atmospheric pressure plasma device (Piezobrush® PZ2) , by using active gas, low-temperature plasma treatment under irradiation at 0.2 MPa for a total of 80 seconds at 10 mm (20 seconds per each surface)

Device: plasma spray

control group

NO INTERVENTION

Healing abutments were installed as they came from industry and received no further treatment.

Interventions

Er: YAG laser DEVICE

surface treatment with Er: YAG laser for heating abutments

laser group

plasma spray DEVICE

surface treatment with plasma spray for heating abutments

plasma group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female patients with age range from 20 to 45 years old.
• Patients need placement of fixed implant-supported prosthesis in maxillary arch.
• Patients who are medically free from any systemic diseases as evidenced by the health questionnaire, using modified Cornell medical index (Pendleton et al., 2004).
• patients with good oral hygiene (Plaque Index and bleeding on probing less than or equal to grade 1).
• Absence of any local conditions affecting bone-implant osseointegration (e.g., infection and poor bone density).
• The presence of sufficient bone width and height that permit the placement of implant with minimum diameter 3.5 mm and 8.5 mm length.

You may not qualify if:

• Presence of acute infections.
• Smokers.
• Pregnancy and lactation.
• Patients with a history of bisphosphonates therapy.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University -Faculty of dentistry

Cairo, 1156, Egypt

Location

MeSH Terms

Interventions

Lasers, Solid-State

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: assessor of clinical parameters, histological samples and scanning electron microscopy samples
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of oral medicine and periodontology

Model Details: comparison between three groups

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: April 6, 2023
• Study Start: June 20, 2021
• Primary Completion: June 13, 2022
• Study Completion: September 22, 2022
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)